N/A
N=366
Incubator Weaning of Moderately Preterm Infants
Infant, Newborn · Infant, Moderate Preterm
Bottom Line
View on ClinicalTrials.gov: NCT02160002 ↗Enrolled (actual)
366
Serious AEs
0.3%
Results posted
Dec 2017
Primary outcome: Primary: Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days) — 43; 41 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Weaning from an incubator at a lower weight (1600 grams) (Procedure); Weaning from an incubator at a higher weight (1800 grams) (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- NICHD Neonatal Research Network
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days) |
43; 41 | — |
| SECONDARY Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days) |
24; 19 | — |
| SECONDARY Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts) |
15; 8 | — |
| SECONDARY Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA) |
15.8; 15.8 | — |
| SECONDARY Growth Parameters: Weight at Status |
2336.3; 2353.6 | — |
| SECONDARY Growth Parameters: Length at Status |
44.6; 44.9 | — |
| SECONDARY Growth Parameters: Head Circumference at Status |
31.9; 32.0 | — |
| SECONDARY Postmenstrual Age (PMA) at Discharge |
37.1; 37.0 | — |
| SECONDARY Readmission to the Hospital Within 1 Week of Discharge |
6; 2 | — |
| SECONDARY Death Among Enrolled Infants |
0; 0 | — |
| SECONDARY Transferred to a Non-Network Hospital |
11; 9 | — |
| SECONDARY Length of Stay (LOS) Following Randomization to Hospital Discharge |
28; 27.5 | — |
Summary
The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants.
The hypothesis of this study is that length of hospital stay (from birth to discharge) will be decreased among moderate preterm infants weaned from an incubator to an open crib at a lower versus higher weight, 1600g vs. 1800g.
Eligibility Criteria
Inclusion Criteria
- Gestational age 29 0/7 to 33 6/7 weeks at birth
- Birth weight less than 1600 grams
- Greater than 48 hours of age
- Current weight less than 1540 grams
- In an incubator
Exclusion Criteria
- Receiving phototherapy
- Receiving respiratory support (including CPAP, ventilation, HFNC > 2 LPM)
- Receiving blood pressure support
- Designated for transfer to referral hospital while in incubator
- Known major congenital or chromosomal anomaly
Data sourced from ClinicalTrials.gov (NCT02160002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.