Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial

Infant, Premature Clinical Trial

— CCot  

Official title:

Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial in Prevention of Moderate or Severe Hypothermia in Preterm Infants Requiring at Least 1 Week of Incubator

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03344978
• Other study ID #: UAB Neo 018
• Status: Withdrawn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

This study will determine whether the efficacy of Mylar-lined cardboard cots is equivalent to traditional incubators in their ability to prevent hypothermia (axillary temperature < 36° C) in preterm neonates <36 6/7 weeks gestational age in a randomized cross-over designed trial. Infants will be randomized to receive care in the cardboard cot or incubator and then cross over to the other device for 24 hour periods, rotating for a total of 96 hours total trial time.

Description:

The aim of the trial is to determine whether a corrugated cardboard cot will assist in maintaining infant axillary temperatures comparing it to the temperatures of the same infant being nursed in low heat incubators. The study will be done in the context of standard medical care, including the WHO thermoregulation protocol (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling).

The cardboard cot is approximately 24 inches long to accommodate the length of the infant and about 12 inches wide to accommodate term infants, even beyond the first months after birth. The cots are fully lined with a reflective metallized film sheet of Mylar. The cot will be covered with a cardboard piece also lined in reflective film up to about the infant's shoulders so that the infant's face is visible. Attached to the lid is a 5 inch cardboard flap lined with reflective film which folds down into the body of the cot to reduce heat loss.

Infants ≤ 36 6/7 weeks gestation will be randomized to receive care in a cardboard cot or an incubator. Infants will begin care in one device and after 24 hours will cross over to the other device for another 24 hours. The process will be repeated once more for a total of 96 hours of study duration. The infants will be normothermic and stable when they are enrolled in the trial. Axillary temperatures will be measured at 1 hr, 6 hours and 24 hours after being placed in the cost or incubator. Infants with observed hypothermia (<36° C) will have measures taken to increase temperature (i.e. adding blankets, hat).

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 5 Days

Eligibility

Inclusion Criteria:

• Estimated gestational age < 36 6/7 weeks

• Hospitalized in the NICU at University Teaching Hospital in Zambia

• Requiring incubator/radiant warmer for at least 1 week

Exclusion Criteria:

• Abdominal wall defect or myelomeningocele

• Major congenital anomalies

• Blistering skin disorder

• Suspected Sepsis

• Requiring ongoing respiratory support

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia, Newborn
• Infant, Premature

Intervention

Other:
• Cardboard Cot Care
Infant maintained in reflective film-lined cot for a period of 24 hours. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after randomization. If temperatures found < 36° C. at any time, an additional blanket and hat will be added to infant to improve temperature. Infant may be moved to incubator or radiant warmer. All other care will be standard of care at University Teaching Hospital, including warm delivery rooms, immediate drying, postponed bathing and weighing, early and exclusive breastfeeding, and Kangaroo Mother Care as continuously as possible.
• Incubator Care
Infant maintained in standard incubator for a period of 24 hours. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after randomization. If temperatures found < 36° C. 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 warm delivery rooms, immediate drying, postponed bathing and weighing, early and exclusive breastfeeding, 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.-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature	Temperature taken via axilla for 1 minute duration	1 hour after placement in warming device
Primary	Moderate (32.0-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature	Temperature taken via axilla for 1 minute duration	6 hours after placement in warming device
Primary	Moderate (32.-35.9° C) or Severe (<32.0°C) hypothermia per Axillary Temperature	Temperature taken via axilla for 1 minute duration	24 hours after placement in warming device
Secondary	Normothermia (Axillary temperature 36.0 - 38.0° C)	Temperature taken via axilla for 1 minute duration	1-96 hours after beginning of study
Secondary	Hypothermia (Axillary temperature < 36.0° C)	Temperature taken via axilla for 1 minute duration	1-96 hours after beginning of study
Secondary	Mean Axillary Temperature in each device	Average of all axillary temperatures taken per device	4 months
Secondary	Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device	Temperature taken via axilla for 1 minute duration	1 hour after placement in warming device
Secondary	Rate of Moderate hypothermia (32.0-35.9°C) after placement in warming device	Temperature taken via axilla for 1 minute duration	6 hours after placement in warming device
Secondary	Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device	Temperature taken via axilla for 1 minute duration	24 hours after placement in warming device
Secondary	Rate of Severe hypothermia (<32.0° C) after placement in warming device	Temperature taken via axilla for 1 minute duration	1 hour after placemnt in warming device
Secondary	Rate of Severe hypothermia (<32.0° C) after placement in warming device	Temperature taken via axilla for 1 minute duration	6 hours after placement in warming device
Secondary	Rate of Severe hypothermia (<32.0° C) after placement in warming device	Temperature taken via axilla for 1 minute duration	24 hours after placement in warming device
Secondary	Rate of Hyperthermia (>38.0°C) after placement in warming device	Temperature taken via axilla for 1 minute duration	4 months