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

Not Applicable

Withdrawn

• Conditions: Infant, Premature
• Interventions: Other: Cardboard Cot Care; Other: Open Crib

• Registration Number: NCT03344991
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Study Start: 2019-06-11
• Primary Completion: 2021-09-27
• Study Completion: 2021-09-27
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

Exclusion Criteria

• Major congenital anomalies
• Requiring ongoing respiratory support
• Suspected sepsis

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardboard Cot Care	Cardboard Cot Care	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.
Open Crib	Open Crib	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.

Primary Outcome Measures

Name	Time	Method
Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature	Up to 14 days

Secondary Outcome Measures

Name	Time	Method
Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots	4 months
Mean Axillary Temperatures on All Infants Weaned to Open Cribs	4 months
Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature	Up to14 days
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	24 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