Incubator Weaning of Moderately Preterm Infants

Study Overview
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Brief Summary
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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.

Official Title
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Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial

Conditions
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Infant, Newborn, Infant, Moderate Preterm

Intervention / Treatment
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* Procedure: Weaning from an incubator at a lower weight (1600 grams)
* Procedure: Weaning from an incubator at a higher weight (1800 grams)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 29 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lower Weight (1600 grams)<br>Weaning from an incubator at a lower weight (1600 grams) | Procedure: Weaning from an incubator at a lower weight (1600 grams)<br>* Infants will be weaned from an incubator at a lower weight (1600 grams)<br>|
| Active Comparator: Higher Weight (1800 grams)<br>Weaning from an incubator at a higher weight (1800 grams) | Procedure: Weaning from an incubator at a higher weight (1800 grams)<br>* Infants will be weaned from an incubator at a higher weight (1800 grams)<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incubator Weaning, Moderately Preterm Infants, Growth Velocity