Incubator Weaning of Moderately Preterm Infants

Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Infant, Newborn; Infant, Moderate Preterm
• Intervention / Treatment: Procedure: Weaning from an incubator at a lower weight (1600 grams); Procedure: Weaning from an incubator at a higher weight (1800 grams)

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90025
      • University of California - Los Angeles
    • Palo Alto, California, United States, 94304
      • Stanford University
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Durham, North Carolina, United States, 27705
      • RTI International
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Cincinnati Children's Medical Center
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Columbus, Ohio, United States, 43205
      • Research Institute at Nationwide Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Univeristy of Pennsylvania
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Brown University, Women & Infants Hospital of Rhode Island
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Southwestern Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lower Weight (1600 grams); Weaning from an incubator at a lower weight (1600 grams)	Procedure: Weaning from an incubator at a lower weight (1600 grams); Infants will be weaned from an incubator at a lower weight (1600 grams)
ACTIVE_COMPARATOR: Higher Weight (1800 grams); Weaning from an incubator at a higher weight (1800 grams)	Procedure: Weaning from an incubator at a higher weight (1800 grams); Infants will be weaned from an incubator at a higher weight (1800 grams)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)	Number of days the infant stays in hospital after birth until discharge home (up to 120 days).	From birth through discharge

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NICHD Neonatal Research Network
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Brenda B Poindexter, MD, Indiana University; Principal Investigator: Abbot Laptook, MD, Brown University, Women & Infants Hosptial of Rhode Island; Principal Investigator: Kathleen A Kennedy, MD, The University of Texas Health Science Center, Houston; Principal Investigator: Mike Cotten, MD, Duke University

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: J Pediatr. 2020 Mar;218:e5.

Helpful Links

• NICHD Neonatal Research Network site
• NICHD Pregnancy & Perinatology Branch

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2015
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: May 8, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (ESTIMATE): June 10, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Growth Velocity; Incubator Weaning; Moderately Preterm Infants
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: NICHD-NRN-0054