Clinical trial NCT02160002: Incubator Weaning of Moderately Preterm Infants
Official title: Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Newborn
Infant, Moderate Preterm
Keywords: Incubator Weaning
Moderately Preterm Infants
Growth Velocity
Lead sponsor: NICHD Neonatal Research Network
Sponsor class: NETWORK
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-06-10
Enrollment: 366
Sex: ALL
Minimum age (years): 29
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)
timeFrame: From birth through discharge
Secondary outcomes:
measure: Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)
timeFrame: From start of weaning from the incubator to crib through discharge (up to 120 days)
measure: Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)
timeFrame: Through completion of 2 weaning attempts
measure: Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)
timeFrame: Start of weaning from incubator through 36 weeks postmenstrual age (PMA)
measure: Growth Parameters: Weight at Status
timeFrame: Status (discharge, death, transfer to another facility, or 120 days)
measure: Growth Parameters: Length at Status
timeFrame: Status (discharge, death, transfer to another facility, or 120 days)
measure: Growth Parameters: Head Circumference at Status
timeFrame: Status (discharge, death, transfer to another facility, or 120 days)
measure: Postmenstrual Age (PMA) at Discharge
timeFrame: Discharge
measure: Readmission to the Hospital Within 1 Week of Discharge
timeFrame: Discharge through 1 week after discharge.
measure: Death Among Enrolled Infants
timeFrame: Status (discharge, death, transfer to another facility, or 120 days)
measure: Transferred to a Non-Network Hospital
timeFrame: Status (discharge, death, transfer to another facility, or 120 days)
measure: Length of Stay (LOS) Following Randomization to Hospital Discharge
timeFrame: From randomization through discharge.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: RTI International
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Columbus
country: United States
facility: Research Institute at Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Univeristy of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Brown University, Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: Case Western Reserve University, Rainbow Babies and Children's Hospital
name: Michele C Walsh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: Myra Wyckoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Seetha Shankaran, MD
role: STUDY_CHAIR
affiliation: Emory University
name: David Carlton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Kurt Schibler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Brenda B Poindexter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University, Women & Infants Hosptial of Rhode Island
name: Abbot Laptook, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Krisa P Van Meurs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Waldemar Carlo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Kathleen A Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Mike Cotten, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Edward F Bell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: Kristi Watterberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Barbara Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Carl T D'Angio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Uday Devaskar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute at Nationwide Children's Hospital
name: Pablo Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Mercy Hospital Kansas City
name: William Truog, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Abhik Das, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.