Trial Outcomes & Findings for Hydrocortisone for BPD (NCT NCT01353313)

NCT ID: NCT01353313

Last Updated: 2025-02-27

Results Overview

Survival without moderate or severe physiologic BPD at 36 weeks postmenstrual age. Moderate or severe physiologic BPD is defined as a requirement for supplemental oxygen and/or positive airway pressure to maintain oxygen saturation greater than 90 percent. A room air challenge was performed for infants estimated to be receiving less than 0.30 FiO2 by nasal cannula.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 800 participants
• Primary outcome timeframe: From day of randomization to 36 weeks post menstrual age
• Results posted on: 2025-02-27

Participant Flow

Participant milestones

Measure	Hydrocortisone Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo Saline placebo administered intravenously or orally if no intravenous line was available.
Overall Study STARTED	398	402
Overall Study Completed Assessment for Neurodevelopmental Impairment	321	318
Overall Study Died After Discharge	8	6
Overall Study Died Before Discharge	35	40
Overall Study Survived to Discharge	363	362
Overall Study COMPLETED	364	364
Overall Study NOT COMPLETED	34	38

Reasons for withdrawal

Measure	Hydrocortisone Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo Saline placebo administered intravenously or orally if no intravenous line was available.
Overall Study Lost to Follow-up	22	23
Overall Study Incomplete Follow-up or No Study Data	12	15

Baseline Characteristics

Hydrocortisone for BPD

Baseline characteristics by cohort

Measure	Hydrocortisone n=398 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=402 Participants Saline placebo administered intravenously or orally if no intravenous line was available.	Total n=800 Participants Total of all reporting groups
Age, Continuous	24.9 weeks STANDARD_DEVIATION 2 • n=5 Participants	24.9 weeks STANDARD_DEVIATION 2 • n=7 Participants	24.9 weeks STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	212 Participants n=5 Participants	167 Participants n=7 Participants	379 Participants n=5 Participants
Sex: Female, Male Male	186 Participants n=5 Participants	235 Participants n=7 Participants	421 Participants n=5 Participants
Race/Ethnicity, Customized Black	139 Participants n=5 Participants	168 Participants n=7 Participants	307 Participants n=5 Participants
Race/Ethnicity, Customized Missing	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Other	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized White	231 Participants n=5 Participants	206 Participants n=7 Participants	437 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	66 Participants n=5 Participants	60 Participants n=7 Participants	126 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	326 Participants n=5 Participants	337 Participants n=7 Participants	663 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Infant Body Weight	710.3 grams STANDARD_DEVIATION 162.7 • n=5 Participants	720.4 grams STANDARD_DEVIATION 171.8 • n=7 Participants	715.4 grams STANDARD_DEVIATION 167.3 • n=5 Participants
Maternal Education College degree/more	66 Participants n=5 Participants	69 Participants n=7 Participants	135 Participants n=5 Participants
Maternal Education High school degree	101 Participants n=5 Participants	108 Participants n=7 Participants	209 Participants n=5 Participants
Maternal Education Less than High school degree	68 Participants n=5 Participants	59 Participants n=7 Participants	127 Participants n=5 Participants
Maternal Education Partial college	78 Participants n=5 Participants	85 Participants n=7 Participants	163 Participants n=5 Participants
Maternal Education Unknown	85 Participants n=5 Participants	81 Participants n=7 Participants	166 Participants n=5 Participants

PRIMARY outcome

Timeframe: From day of randomization to 36 weeks post menstrual age

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Survival without moderate or severe physiologic BPD at 36 weeks postmenstrual age. Moderate or severe physiologic BPD is defined as a requirement for supplemental oxygen and/or positive airway pressure to maintain oxygen saturation greater than 90 percent. A room air challenge was performed for infants estimated to be receiving less than 0.30 FiO2 by nasal cannula.

Outcome measures

Measure	Hydrocortisone n=398 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=402 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) Moderate/severe BPD or death	332 Participants	349 Participants
Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) Survival without moderate/severe physiologic bronchopulmonary dysplasia (BPD)	66 Participants	53 Participants

PRIMARY outcome

Timeframe: From day of randomization to 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data at the two-year followup.

Survival without moderate or severe neurodevelopmental impairment (NDI) at 22-26 months corrected age. NDI is defined as defined as any of: Bayley Scales of Infant and Toddler Development-III (Bayley-III) cognitive composite score less than 85 (standardized mean 100, SD 15, range 55-145) or motor composite score less than 85 (standardized mean 100, range 45-155) (lower scores indicating greater impairment), Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment), severe vision impairment in both eyes (consistent with refraction from less than 20 to 200), or bilateral hearing impairment with or without amplification (by report).

Outcome measures

Measure	Hydrocortisone n=358 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=360 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) Moderate/severe NDI or death	226 Participants	226 Participants
Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) Survival without moderate/severe neurodevelopmental impairment (NDI)	132 Participants	134 Participants

SECONDARY outcome

Timeframe: From day of randomization to day 14 post randomization

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Successful extubation during the intervention period, defined as remaining extubated for greater than or equal to 1 week, including greater than or equal to 3 days after the last dose of study medication. An extubation attempt was required after 72 hours of study drug and 24 hours after meeting the following: FiO2 less than 0.40 to maintain a saturation of greater than or equal to 88 percent, mean airway pressure less than 8 cm H2O, and hemodynamically stable in the opinion of the clinical team.

Outcome measures

Measure	Hydrocortisone n=398 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=402 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Successful Extubation Successful extubation	178 Participants	135 Participants
Number of Participants With Successful Extubation Unsuccessful or no extubation	220 Participants	267 Participants

SECONDARY outcome

Timeframe: From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Infant died before discharge home.

Outcome measures

Measure	Hydrocortisone n=398 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=402 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Total Deaths Before Discharge Survival to discharge	363 Participants	362 Participants
Total Deaths Before Discharge Death before discharge	35 Participants	40 Participants

SECONDARY outcome

Timeframe: At 36 weeks postmenstrual age

Population: The analysis population includes all randomized infants with available data at hospital discharge.

BPD grade at 36 weeks postmenstrual age. BPD grades are defined as: 1. No support/room air; 2. Nasal cannula (NC) O2 less than or equal to 2L; 3. NC O2 greater than 2L or CPAP/NIPPV; 4. Invasive PPV

Outcome measures

Measure	Hydrocortisone n=375 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=367 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age Invasive PPV	63 Participants	51 Participants
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age NC O2 greater than 2L or CPAP/NIPPV	152 Participants	159 Participants
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age Nasal cannula O2 less than or equal to 2L	120 Participants	124 Participants
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age No support, room air	40 Participants	33 Participants

SECONDARY outcome

Timeframe: From birth to 36 weeks postmenstrual age

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of days on mechanical ventilation (using high frequency ventilator or conventional ventilator)

Outcome measures

Measure	Hydrocortisone n=368 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=368 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Days of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA)	37 Days Interval 27.0 to 54.0	40 Days Interval 30.0 to 55.0

SECONDARY outcome

Timeframe: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

Population: The analysis population includes all randomized infants with available data who survived up to hospital discharge.

Number of days of oxygen supplementation from birth to discharge home

Outcome measures

Measure	Hydrocortisone n=362 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=362 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Duration of Oxygen Supplementation up to Status	104.5 Days Interval 84.0 to 120.0	104 Days Interval 83.0 to 120.0

SECONDARY outcome

Timeframe: From birth up to one year

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of days infant stayed in hospitals, among those who survived to discharge

Outcome measures

Measure	Hydrocortisone n=362 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=362 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Length of Hospital Stay in Days Among Survivors to Discharge	127.5 Days Interval 104.0 to 158.0	125.5 Days Interval 106.0 to 155.0

SECONDARY outcome

Timeframe: From birth to 36 weeks postmenstrual age

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Infant received dexamethasone anytime before 36 weeks postmenstrual age.

Outcome measures

Measure	Hydrocortisone n=379 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=377 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA) Dexamethasone not given before 36 weeks PMA	229 Participants	220 Participants
Number of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA) Dexamethasone given before 36 weeks PMA	150 Participants	157 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data who survived up to the two-year followup.

Severity of neurodevelopmental impairment, defined as one or more of: Bayley Scales of Infant Development-III (Bayley-III) cognitive score <85 (standardized mean 100, SD 15, range 55-145), Bayley-III motor score <85 (standardized mean 100, range 45-155), Gross Motor Function Classification System (GMFCS) level ≥2, severe vision impairment in both eyes (consistent with refraction <20-200), or bilateral hearing impairment with or without amplification (by report).

Bayley-III = Bayley Scales of Infant Development III (Cognitive score standardized mean 100, SD 15, range 55-145 motor score standardized mean 100, range 45-155; higher score indicates better performance (20))

Outcome measures

Measure	Hydrocortisone n=315 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=314 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI Moderate	98 Participants	98 Participants
Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI Normal/mild	132 Participants	134 Participants
Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI Severe/profound	85 Participants	82 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data who survived up to the two-year followup.

Number of infants with Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment)

Outcome measures

Measure	Hydrocortisone n=331 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=329 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Gross Motor Function Greater Than or Equal to Level 2 Gross motor function less than II	283 Participants	288 Participants
Number of Participants With Gross Motor Function Greater Than or Equal to Level 2 Gross motor function level II or greater	48 Participants	41 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data who survived up to the two-year followup.

Number of infants with moderate or severe grade of cerebral palsy. Cerebral Palsy was diagnosed when there were definite abnormalities observed in the neuromotor exam, and functional challenges as classified by GMFCS level, and classified as moderate if GMFCS level was II or III and severe if level IV or V (40).

Outcome measures

Measure	Hydrocortisone n=330 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=330 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Moderate-severe Cerebral Palsy Moderate or severe cerebral palsy	41 Participants	33 Participants
Number of Participants With Moderate-severe Cerebral Palsy Not moderate or severe cerebral palsy	289 Participants	297 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data who survived up to the two-year followup.

Number of infants with bilateral hearing impairment with or without amplification (by report)

Outcome measures

Measure	Hydrocortisone n=328 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=327 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Severe Hearing Impairment (by Report) Not severe hearing impairment	319 Participants	313 Participants
Number of Participants With Severe Hearing Impairment (by Report) Severe hearing impairment	9 Participants	14 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data who survived up to the two-year followup.

Number of infants with severe vision impairment in both eyes (consistent with refraction less than 20-200)

Outcome measures

Measure	Hydrocortisone n=330 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=330 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With no/Some Functional Vision Not severe vision impairment	325 Participants	321 Participants
Number of Participants With no/Some Functional Vision Severe vision impairment	5 Participants	9 Participants

SECONDARY outcome

Timeframe: At 36 weeks post-menstrual age

Population: The analysis population includes all randomized infants with available data between 35 and 37 weeks at discharge.

This is measured as the weight Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average weight, and negative scores denote less than average weight.

Outcome measures

Measure	Hydrocortisone n=366 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=363 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Weight Growth Measure Following Extremely Preterm Birth	-1.68 Z-score Standard Deviation 1.01	-1.65 Z-score Standard Deviation 0.98

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data between 18 and 30 months at follow-up.

This is measured as the weight Z-score at 22-26 months corrected age. The Z-score is determined using the WHO weight-for-age chart, and is derived from a standardized normal distribution, where 0 designates average weight-for-age, and negative scores denote less than average weight-for-age.

Outcome measures

Measure	Hydrocortisone n=319 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=316 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Follow-up Weight Growth Measure Following Extremely Preterm Birth	-0.51 Z-score Standard Deviation 1.04	-0.44 Z-score Standard Deviation 1.15

SECONDARY outcome

Timeframe: At 36 weeks post-menstrual age

Population: The analysis population includes all randomized infants with available data between 35 and 37 weeks at discharge.

This is measured as the length Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average length, and negative scores denote less than average length.

Outcome measures

Measure	Hydrocortisone n=340 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=340 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Length Growth Measure Following Extremely Preterm Birth	-2.33 Z-score Standard Deviation 1.16	-2.21 Z-score Standard Deviation 1.14

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data between 18 and 30 months at follow-up.

This is measured as the length Z-score at 22-26 months corrected age. The Z-score is determined using the WHO length-for-age chart, and is derived from a standardized normal distribution, where 0 designates average length-for-age, and negative scores denote less than average length-for-age.

Outcome measures

Measure	Hydrocortisone n=316 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=314 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Follow-up Length Growth Measure Following Extremely Preterm Birth	-0.93 Z-score Standard Deviation 1.17	-0.94 Z-score Standard Deviation 1.22

SECONDARY outcome

Timeframe: At 36 weeks post-menstrual age

Population: The analysis population includes all randomized infants with available data between 35 and 37 weeks at discharge.

This is measured as the head circumference Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average head circumference, and negative scores denote less than average head circumference.

Outcome measures

Measure	Hydrocortisone n=353 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=354 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Head Circumference Growth Measure Following Extremely Preterm Birth	-1.68 Z-score Standard Deviation 1.34	-1.74 Z-score Standard Deviation 1.17

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data between 18 and 30 months at follow-up.

This is measured as the head circumference Z-score at 22-26 months corrected age. The Z-score is determined using the WHO head circumference-for-age chart, and is derived from a standardized normal distribution, where 0 designates average head circumference-for-age, and negative scores denote less than average head circumference-for-age.

Outcome measures

Measure	Hydrocortisone n=314 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=301 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Follow-up Head Circumference Growth Measure Following Extremely Preterm Birth	-0.45 Z-score Standard Deviation 1.41	-0.35 Z-score Standard Deviation 1.42

SECONDARY outcome

Timeframe: At 40 weeks post menstrual age

Population: The analysis population includes all randomized infants with available data at hospital discharge.

BPD grade at 40 weeks postmenstrual age. BPD grades are defined as: 1. No support/room air; 2. Nasal cannula (NC) O2 less than or equal to 2L; 3. NC O2 greater than 2L or CPAP/NIPPV; 4. Invasive PPV

Outcome measures

Measure	Hydrocortisone n=279 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=284 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade 40 Weeks Postmenstrual Age Invasive PPV	46 Participants	38 Participants
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade 40 Weeks Postmenstrual Age NC O2 greater than 2L or CPAP/NIPPV	73 Participants	65 Participants
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade 40 Weeks Postmenstrual Age Nasal cannula O2 less than or equal to 2L	124 Participants	129 Participants
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade 40 Weeks Postmenstrual Age No support, room air	36 Participants	52 Participants

SECONDARY outcome

Timeframe: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

Population: The analysis population includes all randomized infants with available data who survived up to hospital discharge.

Number of days on mechanical ventilation (using high frequency ventilator or conventional ventilator) up to status

Outcome measures

Measure	Hydrocortisone n=361 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=362 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Days of Mechanical Ventilation up to Status	37 Days Interval 27.0 to 56.0	41 Days Interval 30.0 to 56.0

SECONDARY outcome

Timeframe: From birth to 36 weeks postmenstrual age

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of days of oxygen supplementation from birth to 36 weeks post menstrual age

Outcome measures

Measure	Hydrocortisone n=369 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=368 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Duration of Oxygen Supplementation Among Survivors to 36 Weeks	74 Days Interval 65.0 to 81.0	73 Days Interval 64.0 to 82.0

SECONDARY outcome

Timeframe: From postnatal day 15 to 36 weeks post menstrual age or Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

Population: The analysis population includes all randomized infants with available data who were extubated prior to hospital discharge.

Number of days on invasive PPV after postnatal day 14

Outcome measures

Measure	Hydrocortisone n=161 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=124 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Duration of Invasive Positive Pressure Ventilation (PPV) After Postnatal Day 14	29 Days Interval 16.0 to 40.0	27 Days Interval 16.0 to 34.5

SECONDARY outcome

Timeframe: From postnatal day 15 to 36 weeks post menstrual age or Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

Population: The analysis population includes all randomized infants with available data who were extubated prior to hospital discharge.

Number of days of non-invasive PPV after postnatal day 14

Outcome measures

Measure	Hydrocortisone n=161 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=124 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Duration of Non-invasive Positive Pressure Ventilation (PPV) (Nasal IPPV/CPAP) After Postnatal Day 14	13 Days Interval 8.0 to 18.0	13 Days Interval 7.0 to 19.0

SECONDARY outcome

Timeframe: From randomization to day 14 post randomization

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants who received Inhaled glucocorticoids during the study intervention period

Outcome measures

Measure	Hydrocortisone n=396 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=399 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants Who Received Inhaled Glucocorticoids During Study Period Did not receive inhaled glucocorticoids during study period	345 Participants	355 Participants
Number of Participants Who Received Inhaled Glucocorticoids During Study Period Received inhaled glucocorticoids during study period	51 Participants	44 Participants

SECONDARY outcome

Timeframe: From randomization to day 14 post randomization

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants who received other systemic glucocorticoids during the study intervention period

Outcome measures

Measure	Hydrocortisone n=396 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=399 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants Who Received Other Systemic Glucocorticoids During Study Period Did not receive other systemic glucocorticoids during study period	342 Participants	334 Participants
Number of Participants Who Received Other Systemic Glucocorticoids During Study Period Received other systemic glucocorticoids during study period	54 Participants	65 Participants

SECONDARY outcome

Timeframe: From birth to 36 weeks postmenstrual age

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of days infant received dexamethasone anytime before 36 weeks postmenstrual age.

Outcome measures

Measure	Hydrocortisone n=150 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=157 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Days Dexamethasone Given Before 36 Weeks PMA	10 Days Interval 8.0 to 12.0	10 Days Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants with a Patent Ductus Arteriosus (PDA) that was treated with medicine or surgery

Outcome measures

Measure	Hydrocortisone n=398 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=402 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Patent Ductus Arteriosus (PDA) Treated With Medication or Surgery Not PDA treated with medication or surgery	206 Participants	209 Participants
Number of Participants With Patent Ductus Arteriosus (PDA) Treated With Medication or Surgery PDA treated with medication or surgery	192 Participants	193 Participants

SECONDARY outcome

Timeframe: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants diagnosed with Necrotizing Enterocolitis (NEC)

Outcome measures

Measure	Hydrocortisone n=398 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=402 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants Diagnosed With Necrotizing Enterocolitis (NEC) Diagnosed with NEC	33 Participants	46 Participants
Number of Participants Diagnosed With Necrotizing Enterocolitis (NEC) Not diagnosed with NEC	365 Participants	356 Participants

SECONDARY outcome

Timeframe: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants diagnosed with ROP stage 3 or worse in either eye. ROP stage 3 or worse is determined based on the extent of extraretinal fibrovascular proliferation. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease.

Outcome measures

Measure	Hydrocortisone n=382 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=376 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Retinopathy of Prematurity (ROP) Stage 3 or Worse Diagnosed with ROP stage 3 or worse	105 Participants	116 Participants
Number of Participants With Retinopathy of Prematurity (ROP) Stage 3 or Worse Not diagnosed with ROP stage 3 or worse	277 Participants	260 Participants

SECONDARY outcome

Timeframe: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants receiving therapy for Retinopathy of prematurity (ROP)

Outcome measures

Measure	Hydrocortisone n=379 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=376 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants Receiving Therapy for Retinopathy of Prematurity (ROP) Did not receive therapy for ROP	311 Participants	293 Participants
Number of Participants Receiving Therapy for Retinopathy of Prematurity (ROP) Received therapy for ROP	68 Participants	83 Participants

SECONDARY outcome

Timeframe: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants with severe IVH, grade 3 or 4. Severity of IVH is hierarchical. Grade 3 occurs when the ventricular size is enlarged and blood/echodensity is in the ventricle. Grade 4 occurs when blood/echodensity is in the parenchyma.

Outcome measures

Measure	Hydrocortisone n=397 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=402 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Severe Intraventricular Hemorrhage (IVH) Not severe IVH, grade 3 or 4	316 Participants	331 Participants
Number of Participants With Severe Intraventricular Hemorrhage (IVH) Severe IVH, grade 3 or 4	81 Participants	71 Participants

SECONDARY outcome

Timeframe: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

Population: The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants with Periventricular leukomalacia

Outcome measures

Measure	Hydrocortisone n=398 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=402 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Periventricular Leukomalacia No periventricular leukomalacia	376 Participants	378 Participants
Number of Participants With Periventricular Leukomalacia Periventricular leukomalacia	22 Participants	24 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data at the two-year followup.

Number of infants with NDI. NDI is defined as defined as any of: Bayley Scales of Infant and Toddler Development-III (Bayley-III) cognitive composite score less than 85 (standardized mean 100, SD 15, range 55-145) or motor composite score less than 85 (standardized mean 100, range 45-155) (lower scores indicating greater impairment), Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment), severe vision impairment in both eyes (consistent with refraction less than 20-200), or bilateral hearing impairment with or without amplification (by report).

Outcome measures

Measure	Hydrocortisone n=321 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=319 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Neurodevelopmental Impairment (NDI) Neurodevelopmental impairment	189 Participants	185 Participants
Number of Participants With Neurodevelopmental Impairment (NDI) No neurodevelopmental impairment	132 Participants	134 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data at the two-year followup.

Number of infants with a BSID-III cognitive composite score less than 85. (standardized mean 100, SD 15, range 55-145). Higher scores indicate better performance. Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.

Outcome measures

Measure	Hydrocortisone n=318 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=318 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 85 Composite cognitive score greater or equal to 85	168 Participants	176 Participants
Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 85 Composite cognitive score less than 85	150 Participants	142 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data at the two-year followup.

Number of infants with a BSID-III cognitive composite score less than 70. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.

Outcome measures

Measure	Hydrocortisone n=318 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=318 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 70 Composite cognitive score greater or equal to 70	259 Participants	269 Participants
Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 70 Composite cognitive score less than 70	59 Participants	49 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data at the two-year followup.

Number of infants with a BSID-III motor composite score less than 85. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.

Outcome measures

Measure	Hydrocortisone n=310 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=310 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 85 Composite motor score greater or equal to 85	164 Participants	158 Participants
Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 85 Composite motor score less than 85	146 Participants	152 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data at the two-year followup.

Number of infants with a BSID-III motor composite score less than 70. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.

Outcome measures

Measure	Hydrocortisone n=310 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=310 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 70 Composite motor score greater or equal to 70	241 Participants	246 Participants
Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 70 Composite motor score less than 70	69 Participants	64 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants with available data at the two-year followup.

Number of infants with cerebral palsy. Cerebral Palsy was diagnosed when there were definite abnormalities observed in the neuromotor exam, and functional challenges as classified by GMFCS level, and classified as moderate if GMFCS level was II or III and severe if level IV or V (40).

Outcome measures

Measure	Hydrocortisone n=330 Participants Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=330 Participants Saline placebo administered intravenously or orally if no intravenous line was available.
Number of Participants With Any Cerebral Palsy Any cerebral palsy	84 Participants	71 Participants
Number of Participants With Any Cerebral Palsy No cerebral palsy	246 Participants	259 Participants

Adverse Events

Hydrocortisone

Serious events: 84 serious events

Other events: 106 other events

Deaths: 43 deaths

Placebo

Serious events: 95 serious events

Other events: 95 other events

Deaths: 46 deaths

Serious adverse events

Measure	Hydrocortisone n=398 participants at risk Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=402 participants at risk Saline placebo administered intravenously or orally if no intravenous line was available.
Blood and lymphatic system disorders Thrombocytopenia	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Cardiac disorders Tachycardia	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Congenital, familial and genetic disorders Adrenal insufficiency neonatal	1.3% 5/398 • Birth to 36 weeks PMA	4.0% 16/402 • Birth to 36 weeks PMA
Congenital, familial and genetic disorders Patent ductus arteriosus	0.25% 1/398 • Birth to 36 weeks PMA	1.00% 4/402 • Birth to 36 weeks PMA
Gastrointestinal disorders Abdominal compartment syndrome	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Gastrointestinal disorders Intestinal perforation	2.3% 9/398 • Birth to 36 weeks PMA	3.2% 13/402 • Birth to 36 weeks PMA
Gastrointestinal disorders Lip ulceration	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Gastrointestinal disorders Necrotizing enterocolitis neonatal	0.50% 2/398 • Birth to 36 weeks PMA	1.2% 5/402 • Birth to 36 weeks PMA
Gastrointestinal disorders Necrotizing enterocolitis neonatal (Totalis)	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Hepatobiliary disorders Liver injury	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Infections and infestations Nosocomial infection	8.0% 32/398 • Birth to 36 weeks PMA	7.2% 29/402 • Birth to 36 weeks PMA
Infections and infestations Osteomyelitis	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Infections and infestations Pneumonia	1.5% 6/398 • Birth to 36 weeks PMA	0.50% 2/402 • Birth to 36 weeks PMA
Infections and infestations Pneumonia (MRSA)	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Infections and infestations Sepsis neonatal	0.50% 2/398 • Birth to 36 weeks PMA	0.75% 3/402 • Birth to 36 weeks PMA
Infections and infestations Septic shock	0.25% 1/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Infections and infestations Ureaplasma infection	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Infections and infestations Urinary tract infection	0.50% 2/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Injury, poisoning and procedural complications Extra-axial hemorrhage	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Metabolism and nutrition disorders Hyperglycaemia	7.0% 28/398 • Birth to 36 weeks PMA	4.7% 19/402 • Birth to 36 weeks PMA
Metabolism and nutrition disorders Hyperkalemia	0.50% 2/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Metabolism and nutrition disorders Hyponatremia	0.25% 1/398 • Birth to 36 weeks PMA	1.00% 4/402 • Birth to 36 weeks PMA
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/398 • Birth to 36 weeks PMA	0.50% 2/402 • Birth to 36 weeks PMA
Musculoskeletal and connective tissue disorders Rickets	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Nervous system disorders Hydrocephalus	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Pregnancy, puerperium and perinatal conditions Hydrops foetalis	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Renal and urinary disorders Acute kidney injury	0.25% 1/398 • Birth to 36 weeks PMA	0.50% 2/402 • Birth to 36 weeks PMA
Renal and urinary disorders Acute renal failure	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Renal and urinary disorders Anuria	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Renal and urinary disorders Oliguria	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Renal and urinary disorders Renal failure	0.00% 0/398 • Birth to 36 weeks PMA	0.50% 2/402 • Birth to 36 weeks PMA
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Respiratory, thoracic and mediastinal disorders Respiratory failure	15.3% 61/398 • Birth to 36 weeks PMA	15.2% 61/402 • Birth to 36 weeks PMA
Vascular disorders Hypertension	3.8% 15/398 • Birth to 36 weeks PMA	1.00% 4/402 • Birth to 36 weeks PMA
Vascular disorders Hypotension	0.50% 2/398 • Birth to 36 weeks PMA	0.50% 2/402 • Birth to 36 weeks PMA

Other adverse events

Measure	Hydrocortisone n=398 participants at risk Hydrocortisone sodium succinate administered intravenously or orally if no intravenous line was available, tapered over 10 days.	Placebo n=402 participants at risk Saline placebo administered intravenously or orally if no intravenous line was available.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Cardiac disorders Supraventricular tachycardia	0.00% 0/398 • Birth to 36 weeks PMA	0.50% 2/402 • Birth to 36 weeks PMA
Cardiac disorders Tachycardia	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Congenital, familial and genetic disorders Adrenal insufficiency neonatal	5.5% 22/398 • Birth to 36 weeks PMA	6.0% 24/402 • Birth to 36 weeks PMA
Congenital, familial and genetic disorders Patent ductus arteriosus	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Gastrointestinal disorders Intestinal perforation	1.3% 5/398 • Birth to 36 weeks PMA	1.2% 5/402 • Birth to 36 weeks PMA
Gastrointestinal disorders Necrotizing enterocolitis neonatal (Suspected)	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Infections and infestations Bacterial disease carrier	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Infections and infestations Nosocomial infection	4.5% 18/398 • Birth to 36 weeks PMA	6.7% 27/402 • Birth to 36 weeks PMA
Infections and infestations Pneumonia	0.25% 1/398 • Birth to 36 weeks PMA	0.75% 3/402 • Birth to 36 weeks PMA
Infections and infestations Pneumonia mycoplasmal	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Infections and infestations Sepsis neonatal	1.3% 5/398 • Birth to 36 weeks PMA	1.7% 7/402 • Birth to 36 weeks PMA
Infections and infestations Tracheitis	0.50% 2/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Infections and infestations Urinary tract infection	0.00% 0/398 • Birth to 36 weeks PMA	0.75% 3/402 • Birth to 36 weeks PMA
Infections and infestations Wound infection (Neck)	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Investigations Alkaline phosphatase NOS increased	0.25% 1/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Metabolism and nutrition disorders Hyperglycaemia	6.3% 25/398 • Birth to 36 weeks PMA	3.0% 12/402 • Birth to 36 weeks PMA
Metabolism and nutrition disorders Hyperkalemia	1.3% 5/398 • Birth to 36 weeks PMA	1.5% 6/402 • Birth to 36 weeks PMA
Metabolism and nutrition disorders Hypernatremia	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Metabolism and nutrition disorders Hyponatremia	1.0% 4/398 • Birth to 36 weeks PMA	0.50% 2/402 • Birth to 36 weeks PMA
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Nervous system disorders Hydrocephalus	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Renal and urinary disorders Oliguria	0.50% 2/398 • Birth to 36 weeks PMA	0.00% 0/402 • Birth to 36 weeks PMA
Renal and urinary disorders Prerenal failure	0.00% 0/398 • Birth to 36 weeks PMA	0.25% 1/402 • Birth to 36 weeks PMA
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.3% 41/398 • Birth to 36 weeks PMA	11.9% 48/402 • Birth to 36 weeks PMA
Vascular disorders Hypertension	14.1% 56/398 • Birth to 36 weeks PMA	7.2% 29/402 • Birth to 36 weeks PMA

Additional Information

Kristi Watterberg

University of New Mexico Health Sciences

Phone: 505-272-8609

Email: kwatterberg@salud.unm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee Investigators must adhere to the Neonatal Research Network Publication Policies
• Publication restrictions are in place

Restriction type: OTHER