Trial Outcomes & Findings for Incubator Weaning of Moderately Preterm Infants (NCT NCT02160002)

NCT ID: NCT02160002

Last Updated: 2019-03-22

Results Overview

Number of days the infant stays in hospital after birth until discharge home (up to 120 days).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 366 participants
• Primary outcome timeframe: From birth through discharge
• Results posted on: 2019-03-22

Participant Flow

1565 infants were screened for eligibility. 1199 infants were excluded. 680 were excluded due to not meeting all eligibility conditions, 510 did not get consent for randomization, and 9 were consented but not randomized due to parent (1 infant) or doctor withdrawal (1 infant), becoming medically unstable (3 infants) or other reasons (4 infants).

Participant milestones

Measure	Lower Weight (1600 Grams) Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) Weaning from an incubator at a higher weight (1800 grams)
Overall Study STARTED	187	179
Overall Study Primary Outcome	185	178
Overall Study COMPLETED	185	178
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Lower Weight (1600 Grams) Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) Weaning from an incubator at a higher weight (1800 grams)
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Incubator Weaning of Moderately Preterm Infants

Baseline characteristics by cohort

Measure	Lower Weight (1600 Grams) n=187 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=179 Participants Weaning from an incubator at a higher weight (1800 grams)	Total n=366 Participants Total of all reporting groups
Postmenstrual (PMA) age at start of weaning	33.8 weeks STANDARD_DEVIATION 1.3 • n=5 Participants	34.3 weeks STANDARD_DEVIATION 1.2 • n=7 Participants	34.1 weeks STANDARD_DEVIATION 1.3 • n=5 Participants
Maternal Age	28.8 years STANDARD_DEVIATION 5.8 • n=5 Participants	28.9 years STANDARD_DEVIATION 6.1 • n=7 Participants	28.8 years STANDARD_DEVIATION 5.9 • n=5 Participants
Cesarean Delivery	136 Participants n=5 Participants	122 Participants n=7 Participants	258 Participants n=5 Participants
Age, Customized Gestational Age	31.2 weeks STANDARD_DEVIATION 1.3 • n=5 Participants	31.1 weeks STANDARD_DEVIATION 1.2 • n=7 Participants	31.1 weeks STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	87 Participants n=7 Participants	180 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants	92 Participants n=7 Participants	186 Participants n=5 Participants
Race/Ethnicity, Customized Black	76 Participants n=5 Participants	72 Participants n=7 Participants	148 Participants n=5 Participants
Race/Ethnicity, Customized White	99 Participants n=5 Participants	97 Participants n=7 Participants	196 Participants n=5 Participants
Race/Ethnicity, Customized Other	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: From birth through discharge

Population: 185 infants in the lower weight group and 178 infants in the higher weight group have the date of discharge available.

Number of days the infant stays in hospital after birth until discharge home (up to 120 days).

Outcome measures

Measure	Lower Weight (1600 Grams) n=185 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=178 Participants Weaning from an incubator at a higher weight (1800 grams)
Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)	43 days Interval 32.0 to 55.0	41 days Interval 33.0 to 52.0

SECONDARY outcome

Timeframe: From start of weaning from the incubator to crib through discharge (up to 120 days)

Population: There were 163 infants in the Lower Weight group that were successfully weaned from incubator to the crib; discharge date was missing for one of these infants. There were 159 infants in the Higher Weight group that were successfully weaned from incubator to the crib; 4 infants were missing start of weaning dates because of protocol violations.

Among infants who were successfully weaned, the number of days in the hospital counting from the start of weaning from the incubator to the crib through discharge from the hospital (up to 120 days).

Outcome measures

Measure	Lower Weight (1600 Grams) n=162 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=155 Participants Weaning from an incubator at a higher weight (1800 grams)
Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)	24 days Interval 14.0 to 35.0	19 days Interval 10.0 to 26.0

SECONDARY outcome

Timeframe: Through completion of 2 weaning attempts

Population: 178 infants in the Lower Weight group and 167 infants in the Higher Weight group have the data on whether weaning from incubator to crib was successful after two attempts at weaning.

Failure of wean is defined as axillary temperature less than 36.3°C after one hour in the crib on 2 successive readings, 3 to 4 hours apart, within 24 hours of weaning to the crib in spite of additional clothes/coverings.

Outcome measures

Measure	Lower Weight (1600 Grams) n=178 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=167 Participants Weaning from an incubator at a higher weight (1800 grams)
Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)	15 Participants	8 Participants

SECONDARY outcome

Timeframe: Start of weaning from incubator through 36 weeks postmenstrual age (PMA)

Population: There were 257 (136 LW and 121 HW) infants who remained in the hospital at 36 weeks PMA that have weights measured at 36 weeks PMA. Twenty six infants (10 LW and 16 HW) who were still in the incubator at 36 weeks PMA and 20 infants (7 LW and 13 HW) missing the date of start of weaning were excluded from the analysis.

Growth velocity in terms of weight (g/kg/day), considering infant weight at start of weaning from incubator to crib (following random assignment) and weight at 36 weeks postmenstrual age (PMA).

Outcome measures

Measure	Lower Weight (1600 Grams) n=119 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=92 Participants Weaning from an incubator at a higher weight (1800 grams)
Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)	15.8 grams/kilograms/day Standard Deviation 4.8	15.8 grams/kilograms/day Standard Deviation 4.1

SECONDARY outcome

Timeframe: Status (discharge, death, transfer to another facility, or 120 days)

Population: 185 infants in the Lower Weight group and 177 infants in the Higher Weight group had their weights recorded upon reaching status.

Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days.

Outcome measures

Measure	Lower Weight (1600 Grams) n=185 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=177 Participants Weaning from an incubator at a higher weight (1800 grams)
Growth Parameters: Weight at Status	2336.3 grams Standard Deviation 648.0	2353.6 grams Standard Deviation 522.0

SECONDARY outcome

Timeframe: Status (discharge, death, transfer to another facility, or 120 days)

Population: 174 infants in the Lower Weight group and 169 infants in the Higher Weight group have the length at status data.

Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days.

Outcome measures

Measure	Lower Weight (1600 Grams) n=174 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=169 Participants Weaning from an incubator at a higher weight (1800 grams)
Growth Parameters: Length at Status	44.6 centimeters Standard Deviation 3.2	44.9 centimeters Standard Deviation 2.9

SECONDARY outcome

Timeframe: Status (discharge, death, transfer to another facility, or 120 days)

Population: 182 infants in the Lower Weight group and 173 infants in the Higher Weight group have the head circumference at status data.

Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days.

Outcome measures

Measure	Lower Weight (1600 Grams) n=182 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=173 Participants Weaning from an incubator at a higher weight (1800 grams)
Growth Parameters: Head Circumference at Status	31.9 centimeters Standard Deviation 2.2	32.0 centimeters Standard Deviation 2.0

SECONDARY outcome

Timeframe: Discharge

Population: 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have postmenstrual age (PMA) at discharge data.

Postmenstrual age (PMA) at discharge is the sum of the gestational age of the infant and its length of stay in hospital from birth to discharge.

Outcome measures

Measure	Lower Weight (1600 Grams) n=185 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=178 Participants Weaning from an incubator at a higher weight (1800 grams)
Postmenstrual Age (PMA) at Discharge	37.1 weeks Interval 36.3 to 38.9	37.0 weeks Interval 36.0 to 38.3

SECONDARY outcome

Timeframe: Discharge through 1 week after discharge.

Population: 174 infants in the Lower Weight group and 168 infants in the Higher Weight group had post discharge follow-up.

Number of infants re-hospitalized within 1 week (7 days) of discharge.

Outcome measures

Measure	Lower Weight (1600 Grams) n=174 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=168 Participants Weaning from an incubator at a higher weight (1800 grams)
Readmission to the Hospital Within 1 Week of Discharge	6 Participants	2 Participants

SECONDARY outcome

Timeframe: Status (discharge, death, transfer to another facility, or 120 days)

Population: 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.

Outcome measures

Measure	Lower Weight (1600 Grams) n=185 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=178 Participants Weaning from an incubator at a higher weight (1800 grams)
Death Among Enrolled Infants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Status (discharge, death, transfer to another facility, or 120 days)

Population: 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.

Number of infants transferred to another non-Network hospital.

Outcome measures

Measure	Lower Weight (1600 Grams) n=185 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=178 Participants Weaning from an incubator at a higher weight (1800 grams)
Transferred to a Non-Network Hospital	11 Participants	9 Participants

SECONDARY outcome

Timeframe: From randomization through discharge.

Population: 185 infants in the Lower Weight group and 178 infants in the Higher Weight group have the date of discharge.

The number of days the infant stayed in hospital after randomization to the study until discharge.

Outcome measures

Measure	Lower Weight (1600 Grams) n=185 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=178 Participants Weaning from an incubator at a higher weight (1800 grams)
Length of Stay (LOS) Following Randomization to Hospital Discharge	28 days Interval 19.0 to 39.0	27.5 days Interval 20.0 to 37.0

POST_HOC outcome

Timeframe: 24 hours after successful wean to 36 weeks postmenstrual age (PMA)

Population: 257 infants (136 LW, 121 HW) remained in hospital at 36 weeks PMA w/ weight measured at 36 weeks PMA. 26 (10 LW, 16 HW) were still in incubator at 36 weeks PMA, 31 (16 LW, 15 HW) were missing weight after 24 hrs of successful wean, and 4 (LW) w/ weights measured at 24 hrs after successful wean were missing date of 24 hr weight after successful wean

Growth velocity in terms of weight (g/kg/day), considering infant weight at 24 hours after successful wean to crib and weight at 36 weeks postmenstrual age (PMA).

Outcome measures

Measure	Lower Weight (1600 Grams) n=106 Participants Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=90 Participants Weaning from an incubator at a higher weight (1800 grams)
Growth Velocity (g/kg/Day) After Transfer to Crib From Incubator to Crib to 36 Weeks Postmenstural Age (PMA)	11.0 grams/kilograms/day Standard Deviation 7.4	9.6 grams/kilograms/day Standard Deviation 7.0

Adverse Events

Lower Weight (1600 Grams)

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Higher Weight (1800 Grams)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lower Weight (1600 Grams) n=187 participants at risk Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=179 participants at risk Weaning from an incubator at a higher weight (1800 grams)
Gastrointestinal disorders Pneumoperitoneum	0.53% 1/187 • Number of events 1 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.	0.00% 0/179 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.

Other adverse events

Measure	Lower Weight (1600 Grams) n=187 participants at risk Weaning from an incubator at a lower weight (1600 grams)	Higher Weight (1800 Grams) n=179 participants at risk Weaning from an incubator at a higher weight (1800 grams)
Metabolism and nutrition disorders Moderate cold stress	5.3% 10/187 • Number of events 10 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.	1.7% 3/179 • Number of events 3 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.
Metabolism and nutrition disorders Severe cold stress	1.6% 3/187 • Number of events 4 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.	0.56% 1/179 • Number of events 1 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.
Cardiac disorders Bradycardia	1.1% 2/187 • Number of events 3 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.	1.1% 2/179 • Number of events 3 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.
Gastrointestinal disorders Feeding Intolerance	0.53% 1/187 • Number of events 3 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.	1.1% 2/179 • Number of events 3 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.
Respiratory, thoracic and mediastinal disorders Desaturations	0.00% 0/187 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.	0.56% 1/179 • Number of events 1 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.
Gastrointestinal disorders NEC IIa	0.53% 1/187 • Number of events 1 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.	0.00% 0/179 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.53% 1/187 • Number of events 1 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.	0.00% 0/179 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.
Cardiac disorders Tachycardia with desaturations	0.53% 1/187 • Number of events 1 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.	0.00% 0/179 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.
Cardiac disorders Increasing heart failure	0.53% 1/187 • Number of events 1 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.	0.00% 0/179 • Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure. Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.

Additional Information

Seetha Shankaran

Wayne State University

Phone: (313) 745-1436

Email: sshankar@med.wayne.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