Incubator Weaning of Moderately Preterm Infants

• Weaning from an incubator at a lower weight (1600 grams) (Procedure): Infants will be weaned from an incubator at a lower weight (1600 grams)
• Weaning from an incubator at a higher weight (1800 grams) (Procedure): Infants will be weaned from an incubator at a higher weight (1800 grams)

Primary outcomes

• Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days) [From birth through discharge]: Number of days the infant stays in hospital after birth until discharge home (up to 120 days).

Secondary outcomes

• Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days) [From start of weaning from the incubator to crib through discharge (up to 120 days)]: 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).
• Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts) [Through completion of 2 weaning attempts]: 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.
• Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA) [Start of weaning from incubator through 36 weeks postmenstrual age (PMA)]: 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).
• Growth Parameters: Weight at Status [Status (discharge, death, transfer to another facility, or 120 days)]: Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
• Growth Parameters: Length at Status [Status (discharge, death, transfer to another facility, or 120 days)]: Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
• Growth Parameters: Head Circumference at Status [Status (discharge, death, transfer to another facility, or 120 days)]: Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
• Postmenstrual Age (PMA) at Discharge [Discharge]: 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.
• Readmission to the Hospital Within 1 Week of Discharge [Discharge through 1 week after discharge.]: Number of infants re-hospitalized within 1 week (7 days) of discharge.
• Death Among Enrolled Infants [Status (discharge, death, transfer to another facility, or 120 days)]
• Transferred to a Non-Network Hospital [Status (discharge, death, transfer to another facility, or 120 days)]: Number of infants transferred to another non-Network hospital.
• Length of Stay (LOS) Following Randomization to Hospital Discharge [From randomization through discharge.]: The number of days the infant stayed in hospital after randomization to the study until discharge.

Sex: All, ages: 29 Weeks to 34 Weeks

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

Participant flow

Outcome results

• Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days) (Primary), Median, days: Lower Weight (1600 Grams) 43 (32 to 55); Higher Weight (1800 Grams) 41 (33 to 52)
• Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days) (Secondary), Median, days: Lower Weight (1600 Grams) 24 (14 to 35); Higher Weight (1800 Grams) 19 (10 to 26)
• Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts) (Secondary), Count of participants, Participants: Lower Weight (1600 Grams) 15; Higher Weight (1800 Grams) 8
• Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA) (Secondary), Mean, grams/kilograms/day: Lower Weight (1600 Grams) 15.8 +/- 4.8; Higher Weight (1800 Grams) 15.8 +/- 4.1
• Growth Parameters: Weight at Status (Secondary), Mean, grams: Lower Weight (1600 Grams) 2336.3 +/- 648.0; Higher Weight (1800 Grams) 2353.6 +/- 522.0
• Growth Parameters: Length at Status (Secondary), Mean, centimeters: Lower Weight (1600 Grams) 44.6 +/- 3.2; Higher Weight (1800 Grams) 44.9 +/- 2.9
• Growth Parameters: Head Circumference at Status (Secondary), Mean, centimeters: Lower Weight (1600 Grams) 31.9 +/- 2.2; Higher Weight (1800 Grams) 32.0 +/- 2.0
• Postmenstrual Age (PMA) at Discharge (Secondary), Median, weeks: Lower Weight (1600 Grams) 37.1 (36.3 to 38.9); Higher Weight (1800 Grams) 37.0 (36.0 to 38.3)
• Readmission to the Hospital Within 1 Week of Discharge (Secondary), Count of participants, Participants: Lower Weight (1600 Grams) 6; Higher Weight (1800 Grams) 2
• Death Among Enrolled Infants (Secondary), Count of participants, Participants: Lower Weight (1600 Grams) 0; Higher Weight (1800 Grams) 0
• Transferred to a Non-Network Hospital (Secondary), Count of participants, Participants: Lower Weight (1600 Grams) 11; Higher Weight (1800 Grams) 9
• Length of Stay (LOS) Following Randomization to Hospital Discharge (Secondary), Median, days: Lower Weight (1600 Grams) 28 (19 to 39); Higher Weight (1800 Grams) 27.5 (20 to 37)
• Growth Velocity (g/kg/Day) After Transfer to Crib From Incubator to Crib to 36 Weeks Postmenstural Age (PMA) (Post hoc), Mean, grams/kilograms/day: Lower Weight (1600 Grams) 11.0 +/- 7.4; Higher Weight (1800 Grams) 9.6 +/- 7.0

Adverse events

Time frame: 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.

Serious adverse events by term

Other adverse events by term

• Results publication: Chowdhary V, Shukla A. Weaning of moderately preterm infants from the incubator to the crib: a randomized clinical trial. Acta Paediatr. 2019 Jul;108(7):1364. doi: 10.1111/apa.14774. Epub 2019 Apr 29. No abstract available. PMID 31033050
• Results publication: Shankaran S, Bell EF, Laptook AR, Saha S, Newman NS, Kazzi SNJ, Barks J, Stoll BJ, Bara R, Gabrio J, Childs K, Das A, Higgins RD, Carlo WA, Sanchez PJ, Carlton DP, Pavageau L, Malcolm WF, D'Angio CT, Ohls RK, Poindexter BB, Sokol GM, Van Meurs KP, Colaizy TT, Khmour A, Puopolo KM, Garg M, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health, and Human Development Neonatal Research Network. Weaning of Moderately Preterm Infants from the Incubator to the Crib: A Randomized Clinical Trial. J Pediatr. 2019 Jan;204:96-102.e4. doi: 10.1016/j.jpeds.2018.08.079. Epub 2018 Oct 15. PMID 30337189

• Michele C Walsh, MD, Principal investigator, Case Western Reserve University, Rainbow Babies and Children's Hospital
• Myra Wyckoff, MD, Principal investigator, University of Texas, Southwestern Medical Center at Dallas
• Seetha Shankaran, MD, Study chair, Wayne State University
• David Carlton, MD, Principal investigator, Emory University
• Kurt Schibler, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
• Brenda B Poindexter, MD, Principal investigator, Indiana University
• Abbot Laptook, MD, Principal investigator, Brown University, Women & Infants Hosptial of Rhode Island
• Krisa P Van Meurs, MD, Principal investigator, Stanford University
• Waldemar Carlo, MD, Principal investigator, University of Alabama at Birmingham
• Kathleen A Kennedy, MD, Principal investigator, The University of Texas Health Science Center, Houston
• Mike Cotten, MD, Principal investigator, Duke University
• Edward F Bell, MD, Principal investigator, University of Iowa
• Kristi Watterberg, MD, Principal investigator, University of New Mexico
• Barbara Schmidt, MD, Principal investigator, University of Pennsylvania
• Carl T D'Angio, MD, Principal investigator, University of Rochester
• Uday Devaskar, MD, Principal investigator, University of California, Los Angeles
• Pablo Sanchez, MD, Principal investigator, Research Institute at Nationwide Children's Hospital
• William Truog, MD, Principal investigator, Children's Mercy Hospital Kansas City
• Abhik Das, PhD, Principal investigator, RTI International