Incubator Weaning of Moderately Preterm Infants
- Conditions
- Infant, NewbornInfant, Moderate Preterm
- Interventions
- Procedure: Weaning from an incubator at a higher weight (1800 grams)Procedure: Weaning from an incubator at a lower weight (1600 grams)
- Registration Number
- NCT02160002
- Lead Sponsor
- NICHD Neonatal Research Network
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 366
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Higher Weight (1800 grams) Weaning from an incubator at a higher weight (1800 grams) Weaning from an incubator at a higher weight (1800 grams) Lower Weight (1600 grams) Weaning from an incubator at a lower weight (1600 grams) Weaning from an incubator at a lower weight (1600 grams)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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).
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.
Death Among Enrolled Infants Status (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.
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.
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.
Trial Locations
- Locations (18)
Wayne State University
🇺🇸Detroit, Michigan, United States
University of California - Los Angeles
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
University of Rochester
🇺🇸Rochester, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
RTI International
🇺🇸Durham, North Carolina, 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
Univeristy of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Brown University, Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States