Incubator Weaning of Moderately Preterm Infants

Infant, Newborn Clinical Trial

Official title:

Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160002
• Other study ID #: NICHD-NRN-0054
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2019
• Source: NICHD Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: June 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Weeks to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Infant, Moderate Preterm
• Infant, Newborn
• Premature Birth

Intervention

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

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Research Institute at Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	RTI International	Durham	North Carolina
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of California - Los Angeles	Los Angeles	California
United States	Stanford University	Palo Alto	California
United States	Univeristy of Pennsylvania	Philadelphia	Pennsylvania
United States	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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.
Secondary	Death Among Enrolled Infants		Status (discharge, death, transfer to another facility, or 120 days)
Secondary	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)
Secondary	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.

External Links

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