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

Infant, Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03344991
• Other study ID #: UAB Neo 019
• Status: Withdrawn
• Phase: N/A
• Start date: June 11, 2019
• Est. completion date: September 27, 2021

Study information

• Verified date: October 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Infant, Premature

Intervention

Other:
• Cardboard Cot Care
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.
• Open Crib
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

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