Trial Outcomes & Findings for Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants (NCT NCT01534481)

Last Updated: 2023-02-06

Results Overview

Mean cognitive composite score (standardized mean 100, SD 15, range 54-145). Subjects who died prior to follow-up assigned the score of 54. (lower scores indicating greater impairment)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

483 participants

Primary outcome timeframe

At 22-26 months corrected age

Results posted on

2023-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Donor Milk Pasteurized donor milk	Formula Preterm infant formula
Overall Study STARTED	239	244
Overall Study Complete Data for BSID III Cognitive Score at 22-26 Months	175	192
Overall Study Died After Discharge	5	7
Overall Study Died Before Discharge	24	18
Overall Study Survived to Discharge	215	226
Overall Study COMPLETED	204	217
Overall Study NOT COMPLETED	35	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Donor Milk Pasteurized donor milk	Formula Preterm infant formula
Overall Study Lost to Follow-up	29	24
Overall Study Incomplete Follow-up or No Study Data	6	3

Baseline Characteristics

Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DONORMILK n=239 Participants Pasteurized donor milk	FORMULA n=244 Participants Preterm infant formula	Total n=483 Participants Total of all reporting groups
Race/Ethnicity, Customized Black	126 Participants n=5 Participants	121 Participants n=7 Participants	247 Participants n=5 Participants
Age, Continuous	26 weeks STANDARD_DEVIATION 1.8 • n=5 Participants	26.1 weeks STANDARD_DEVIATION 1.6 • n=7 Participants	26 weeks STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	133 Participants n=5 Participants	116 Participants n=7 Participants	249 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	128 Participants n=7 Participants	234 Participants n=5 Participants
Race/Ethnicity, Customized Missing	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized White	98 Participants n=5 Participants	108 Participants n=7 Participants	206 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	37 Participants n=5 Participants	31 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	201 Participants n=5 Participants	212 Participants n=7 Participants	413 Participants n=5 Participants
Weight of Infant at Birth	848.6 grams STANDARD_DEVIATION 232 • n=5 Participants	842.5 grams STANDARD_DEVIATION 219.8 • n=7 Participants	845.5 grams STANDARD_DEVIATION 225.8 • n=5 Participants
Maternal Education College degree/more	17 Participants n=5 Participants	23 Participants n=7 Participants	40 Participants n=5 Participants
Maternal Education High school degree	82 Participants n=5 Participants	93 Participants n=7 Participants	175 Participants n=5 Participants
Maternal Education Less than high school degree	64 Participants n=5 Participants	57 Participants n=7 Participants	121 Participants n=5 Participants
Maternal Education Missing	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Maternal Education Partial college	57 Participants n=5 Participants	54 Participants n=7 Participants	111 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants who died or were followed at 22-26 months.

Mean cognitive composite score (standardized mean 100, SD 15, range 54-145). Subjects who died prior to follow-up assigned the score of 54. (lower scores indicating greater impairment)

Outcome measures

Outcome measures
Measure	Donor Milk n=206 Participants Pasteurized donor milk	Formula n=217 Participants Preterm infant formula
Bayley Scales of Infant Development (BSID) Cognitive Composite Score	80.7 Score on a scale Standard Deviation 17.4	81.1 Score on a scale Standard Deviation 16.7

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 1 year following birth

Population: The analysis population includes all randomized infants.

Infant died before discharge home.

Outcome measures

Outcome measures
Measure	Donor Milk n=239 Participants Pasteurized donor milk	Formula n=244 Participants Preterm infant formula
Total Deaths Before Discharge Death before discharge	24 Participants	18 Participants
Total Deaths Before Discharge Survival to discharge	215 Participants	226 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.

Number of infants diagnosed with LOS

Outcome measures

Outcome measures
Measure	Donor Milk n=239 Participants Pasteurized donor milk	Formula n=244 Participants Preterm infant formula
Late Onset Sepsis (LOS) Missing data	1 Participants	0 Participants
Late Onset Sepsis (LOS) Late-onset sepsis	47 Participants	37 Participants
Late Onset Sepsis (LOS) No late-onset sepsis	191 Participants	207 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.

Number of infants diagnosed with NEC

Outcome measures

Outcome measures
Measure	Donor Milk n=239 Participants Pasteurized donor milk	Formula n=244 Participants Preterm infant formula
Necrotizing Enterocolitis (NEC) Necrotizing enterocolitis	10 Participants	22 Participants
Necrotizing Enterocolitis (NEC) No necrotizing enterocolitis	229 Participants	222 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.

A composite outcome that measures the occurrence of death or NEC

Outcome measures

Outcome measures
Measure	Donor Milk n=239 Participants Pasteurized donor milk	Formula n=244 Participants Preterm infant formula
Death or Necrotizing Enterocolitis (NEC) Death or NEC	27 Participants	33 Participants
Death or Necrotizing Enterocolitis (NEC) Survival without NEC	212 Participants	211 Participants

SECONDARY outcome

Timeframe: During Study Intervention, the time between study randomization and discontinuation of study protocol. Infants exited from the study protocol 1-2 weeks prior to anticipated hospital discharge or 120 days, whichever is sooner

Population: The analysis population includes all randomized infants with non-missing data for weight at both the beginning and the end of the study.

Weight-for-age Z-scores were calculated at both baseline (study initiation) and study end (within one week of last study data collected) based on Fenton growth curves (2013). This outcome represents the change in weight-for-age Z-score during the course of the study (i.e., the Z-score at baseline was subtracted from the Z-score at study end). A value of 0 represents that the infant's weight-for-age Z-score is the same at the beginning and the end of the study. Positive values indicate the increase in the infant's weight-for-age Z-score during the study; negative values indicate the decrease in the infant's weight-for-age Z-score during the study.

Outcome measures

Outcome measures
Measure	Donor Milk n=235 Participants Pasteurized donor milk	Formula n=243 Participants Preterm infant formula
Change in Weight-for-age Z-score During Study	-0.4 Change in Z-score (difference) Standard Deviation 0.9	-0.1 Change in Z-score (difference) Standard Deviation 0.9

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants who died or were followed at 22-26 months.

Mean motor composite score (standardized mean 100, range 44-155). Subjects who died prior to follow-up assigned the score of 44. (lower scores indicating greater impairment)

Outcome measures

Outcome measures
Measure	Donor Milk n=202 Participants Pasteurized donor milk	Formula n=213 Participants Preterm infant formula
Bayley Scales of Infant Development (BSID) Motor Composite Score	80.3 Score on a scale Standard Deviation 21.6	80.1 Score on a scale Standard Deviation 19.9

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants who died or were followed at 22-26 months.

Mean language composite score (standardized mean 100, range 46-155). Subjects who died prior to follow-up assigned the score of 46. (lower scores indicating greater impairment)

Outcome measures

Outcome measures
Measure	Donor Milk n=203 Participants Pasteurized donor milk	Formula n=212 Participants Preterm infant formula
Bayley Scales of Infant Development (BSID) Language Composite Score	76.7 Score on a scale Standard Deviation 19.6	75.8 Score on a scale Standard Deviation 18.6

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants who were followed (or adjudicated) at 22-26 months.

Number of infants with moderate or severe grade of cerebral palsy

Outcome measures

Outcome measures
Measure	Donor Milk n=188 Participants Pasteurized donor milk	Formula n=199 Participants Preterm infant formula
Moderate to Severe Cerebral Palsy Missing data	3 Participants	2 Participants
Moderate to Severe Cerebral Palsy Moderate-severe cerebral palsy	14 Participants	20 Participants
Moderate to Severe Cerebral Palsy No moderate-severe cerebral palsy	171 Participants	177 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants who were followed (or adjudicated) at 22-26 months.

Number of infants with NDI. NDI is defined as any of the following: Gross Motor Function Classification System score greater than or equal to 2, Bayley III cognitive or motor score less than 85 (1 standard deviation), Vision Impairment or Hearing impairment

Outcome measures

Outcome measures
Measure	Donor Milk n=188 Participants Pasteurized donor milk	Formula n=199 Participants Preterm infant formula
Neurodevelopmental Impairment (NDI). Missing data	11 Participants	10 Participants
Neurodevelopmental Impairment (NDI). Neurodevelopmental impairment	89 Participants	98 Participants
Neurodevelopmental Impairment (NDI). No neurodevelopmental impairment	88 Participants	91 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants who were followed (or adjudicated) at 22-26 months.

Number of infants with profound impairment.

Outcome measures

Outcome measures
Measure	Donor Milk n=188 Participants Pasteurized donor milk	Formula n=199 Participants Preterm infant formula
Profound Impairment Missing data	4 Participants	5 Participants
Profound Impairment No profound NDI	154 Participants	152 Participants
Profound Impairment Profound NDI	30 Participants	42 Participants

SECONDARY outcome

Timeframe: At 22-26 months corrected age

Population: The analysis population includes all randomized infants who died or were followed (or adjudicated) at 22-26 months.

A composite outcome that measures the occurrence of death through 22-26 months or NDI.

Outcome measures

Outcome measures
Measure	Donor Milk n=217 Participants Pasteurized donor milk	Formula n=224 Participants Preterm infant formula
Death or Neurodevelopmental Impairment (NDI) Missing data	11 Participants	10 Participants
Death or Neurodevelopmental Impairment (NDI) Survival without NDI	88 Participants	91 Participants
Death or Neurodevelopmental Impairment (NDI) Death or NDI	118 Participants	123 Participants

Adverse Events

Donor Milk

Serious events: 48 serious events

Other events: 19 other events

Deaths: 29 deaths

Formula

Serious events: 47 serious events

Other events: 17 other events

Deaths: 25 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Tarah Colaizy

University of Iowa

Phone: 319-356-3508

Email: [email protected]

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

Measure	Donor Milk n=239 participants at risk Pasteurized donor milk	Formula n=244 participants at risk Preterm infant formula
Congenital, familial and genetic disorders Patent ductus arteriosus	0.84% 2/239 • Number of events 2 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.00% 0/244 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Eye disorders Retinopathy of prematurity	0.42% 1/239 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.00% 0/244 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Gastrointestinal disorders Abdominal distension	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Gastrointestinal disorders Gastroesophageal reflux disease	0.42% 1/239 • Number of events 2 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.00% 0/244 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Gastrointestinal disorders Necrotising enterocolitis neonatal	0.84% 2/239 • Number of events 2 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	3.7% 9/244 • Number of events 9 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Hepatobiliary disorders Acute on chronic liver failure	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Hepatobiliary disorders Neonatal cholestasis	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Infections and infestations Coronavirus infection	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Infections and infestations Cytomegalovirus infection	0.42% 1/239 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	1.2% 3/244 • Number of events 3 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Infections and infestations Metapneumovirus infection	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Infections and infestations Neonatal infection	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Infections and infestations Sepsis neonatal	5.4% 13/239 • Number of events 15 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	2.5% 6/244 • Number of events 6 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Infections and infestations Staphylococcal infection	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Metabolism and nutrition disorders Feeding intolerance	0.42% 1/239 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.00% 0/244 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 2 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Metabolism and nutrition disorders Metabolic acidosis	0.42% 1/239 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.00% 0/244 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Metabolism and nutrition disorders Neonatal hypoglycemia	0.42% 1/239 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.00% 0/244 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Nervous system disorders Intraventricular haemorrhage neonatal	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Nervous system disorders Neonatal seizure	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Pregnancy, puerperium and perinatal conditions Hypothermia neonatal	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Renal and urinary disorders Neonatal anuria	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Respiratory, thoracic and mediastinal disorders Apnea	0.42% 1/239 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.00% 0/244 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Respiratory, thoracic and mediastinal disorders Apnea Neonatal	0.42% 1/239 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.00% 0/244 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.
Vascular disorders Hypertension neonatal	0.00% 0/239 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.	0.41% 1/244 • Number of events 1 • From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth. For All-Cause Mortality, the time frame extends to follow-up (22-26 months) since deaths after discharge are included.