Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib

Study Overview
=================
Brief Summary
-----------------
Infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are delivered in a setting where an incubator is not available, will be randomized to either standard protocol of open crib or mylar-lined cardboard cot for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care.

Detailed Description
-----------------
Following parental consent, preterm infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are in the newborn ICU in a setting where an incubator is not available, will be randomized to to transfer either standard protocol of open crib or mylar-lined cardboard cot when their temperatures are stable for transfer. The infants will remain in the cot or crib for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care, including WHO warm chain thermoregulation guidelines of early and exclusive breastfeeding, appropriate bundling and Kangaroo Mother Care as continuously as possible. If at any point a babies becomes moderately (32.0-35.9° C) or severely hypothermic (< 32.0° C), an extra blanket will be added to their bodies and a hat placed on their heads.

Official Title
-----------------
Cardboard Cot in Neonatal Thermoregulation: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib

Conditions
-----------------
Infant, Premature

Intervention / Treatment
-----------------
* Other: Cardboard Cot Care
* Other: Open Crib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Estimated gestational age < 36 6/7 weeks Hospitalized in the newborn ICU at University Teaching Hospital Nursed in an incubator for at least 24 hours Thought to be ready to be weaned from incubator by the clinical staff Exclusion Criteria: Major congenital anomalies Requiring ongoing respiratory support Suspected sepsis

Ages Eligible for Study
-----------------
Minimum Age: 24 Hours
Maximum Age: 2 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Infants will be randomized to either open crib (standard of care) or mylar-lined cardboard box following care in a radiant warmer
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cardboard Cot Care<br>Stable infant will be transferred to cardboard cot, lined with reflective film for duration of hospital stay following weaning from radiant warmer. Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge. | Other: Cardboard Cot Care<br>* When ready to be weaned from radiant warmer, infant will be placed in a reflective film-lined cot for the duration of hospitalization. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge. If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature. All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.<br>|
| Placebo Comparator: Open Crib<br>Stable infant will be transferred to standard of care open crib for duration of hospital stay following weaning from radiant warmer. Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge. | Other: Open Crib<br>* When ready to be weaned from radiant warmer, infant will be placed in a standard of care open crib for the duration of hospitalization. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge. If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature. All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature |  | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature |  | Up to14 days | 
| Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots |  | 4 months | 
| Mean Axillary Temperatures on All Infants Weaned to Open Cribs |  | 4 months | 
| Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature |  | 1 hour after placement in warming device | 
| Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature |  | 6 hours | 
| Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature |  | 24 hours after placement in warming device | 
| Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature |  | 1 hour after placement in warming device | 
| Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature |  | 6 hours after placement in warming device | 
| Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature |  | 24 hours after placement in warming device | 
| Rate of Hyperthemia (>38° C) measured by axillary temperature |  | 14 days | 
| Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature |  | Up to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypothermia, Newborn