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Incubator Weaning of Moderately Preterm Infants

Primary Purpose

Infant, Newborn, Infant, Moderate Preterm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Sponsored by
NICHD Neonatal Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Newborn focused on measuring Incubator Weaning, Moderately Preterm Infants, Growth Velocity

Eligibility Criteria

29 Weeks - 34 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • University of California - Los Angeles
  • Stanford University
  • Emory University
  • Indiana University
  • University of Iowa
  • Wayne State University
  • Children's Mercy Hospital
  • University of New Mexico
  • University of Rochester
  • RTI International
  • Duke University
  • Cincinnati Children's Medical Center
  • Case Western Reserve University
  • Research Institute at Nationwide Children's Hospital
  • Univeristy of Pennsylvania
  • Brown University, Women & Infants Hospital of Rhode Island
  • University of Texas Southwestern Medical Center at Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lower Weight (1600 grams)

Higher Weight (1800 grams)

Arm Description

Weaning from an incubator at a lower weight (1600 grams)

Weaning from an incubator at a higher weight (1800 grams)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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).
Growth Parameters: Weight at Status
Infant weight at status is measured at the time of 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.
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.
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.
Readmission to the Hospital Within 1 Week of Discharge
Number of infants re-hospitalized within 1 week (7 days) of discharge.
Death Among Enrolled Infants
Transferred to a Non-Network Hospital
Number of infants transferred to another non-Network hospital.
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.

Full Information

First Posted
May 8, 2014
Last Updated
March 20, 2019
Sponsor
NICHD Neonatal Research Network
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02160002
Brief Title
Incubator Weaning of Moderately Preterm Infants
Official Title
Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NICHD Neonatal Research Network
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Infant, Moderate Preterm
Keywords
Incubator Weaning, Moderately Preterm Infants, Growth Velocity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower Weight (1600 grams)
Arm Type
Active Comparator
Arm Description
Weaning from an incubator at a lower weight (1600 grams)
Arm Title
Higher Weight (1800 grams)
Arm Type
Active Comparator
Arm Description
Weaning from an incubator at a higher weight (1800 grams)
Intervention Type
Procedure
Intervention Name(s)
Weaning from an incubator at a lower weight (1600 grams)
Intervention Description
Infants will be weaned from an incubator at a lower weight (1600 grams)
Intervention Type
Procedure
Intervention Name(s)
Weaning from an incubator at a higher weight (1800 grams)
Intervention Description
Infants will be weaned from an incubator at a higher weight (1800 grams)
Primary Outcome Measure Information:
Title
Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)
Description
Number of days the infant stays in hospital after birth until discharge home (up to 120 days).
Time Frame
From birth through discharge
Secondary Outcome Measure Information:
Title
Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)
Description
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).
Time Frame
From start of weaning from the incubator to crib through discharge (up to 120 days)
Title
Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)
Description
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.
Time Frame
Through completion of 2 weaning attempts
Title
Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)
Description
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).
Time Frame
Start of weaning from incubator through 36 weeks postmenstrual age (PMA)
Title
Growth Parameters: Weight at Status
Description
Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
Time Frame
Status (discharge, death, transfer to another facility, or 120 days)
Title
Growth Parameters: Length at Status
Description
Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
Time Frame
Status (discharge, death, transfer to another facility, or 120 days)
Title
Growth Parameters: Head Circumference at Status
Description
Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
Time Frame
Status (discharge, death, transfer to another facility, or 120 days)
Title
Postmenstrual Age (PMA) at Discharge
Description
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.
Time Frame
Discharge
Title
Readmission to the Hospital Within 1 Week of Discharge
Description
Number of infants re-hospitalized within 1 week (7 days) of discharge.
Time Frame
Discharge through 1 week after discharge.
Title
Death Among Enrolled Infants
Time Frame
Status (discharge, death, transfer to another facility, or 120 days)
Title
Transferred to a Non-Network Hospital
Description
Number of infants transferred to another non-Network hospital.
Time Frame
Status (discharge, death, transfer to another facility, or 120 days)
Title
Length of Stay (LOS) Following Randomization to Hospital Discharge
Description
The number of days the infant stayed in hospital after randomization to the study until discharge.
Time Frame
From randomization through discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele C Walsh, MD
Organizational Affiliation
Case Western Reserve University, Rainbow Babies and Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myra Wyckoff, MD
Organizational Affiliation
University of Texas, Southwestern Medical Center at Dallas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seetha Shankaran, MD
Organizational Affiliation
Wayne State University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Carlton, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kurt Schibler, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brenda B Poindexter, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abbot Laptook, MD
Organizational Affiliation
Brown University, Women & Infants Hosptial of Rhode Island
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Krisa P Van Meurs, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waldemar Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathleen A Kennedy, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mike Cotten, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward F Bell, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristi Watterberg, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Schmidt, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carl T D'Angio, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Uday Devaskar, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pablo Sanchez, MD
Organizational Affiliation
Research Institute at Nationwide Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Truog, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abhik Das, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
RTI International
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Research Institute at Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Univeristy of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Brown University, Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31033050
Citation
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.
Results Reference
derived
PubMed Identifier
30337189
Citation
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.
Results Reference
derived
Links:
URL
http://neonatal.rti.org/
Description
NICHD Neonatal Research Network site
URL
http://www.nichd.nih.gov/about/org/der/branches/ppb/Pages/overview.aspx
Description
NICHD Pregnancy & Perinatology Branch

Learn more about this trial

Incubator Weaning of Moderately Preterm Infants

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