Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial (CCot)

October 22, 2021 updated by: Colm Travers, University of Alabama at Birmingham

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

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.

Study Overview

Detailed 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).

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 5 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cardboard Cot Care
Stable infant will be nursed in a cardboard cot, lined with reflective film for 24 hour period of time. Infant's axillary temperature will be taken at 1 hour after randomization, at 6 hours after randomization, and 24 hours after randomization. After 24 hours, infant will be swapped to the other arm (Incubator Care), and back for a total of 2 24-hour periods in each arm.
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.
Other Names:
  • CCot
Placebo Comparator: Incubator Care
Stable infant will be nursed in an incubator for 24 hour period of time. Infant's axillary temperature will be taken at 1 hour after randomization, at 6 hours after randomization, and 24 hours after randomization. After 24 hours, infant will be swapped to the other arm (Cardboard Cot Care), and back for a total of 2 24-hour periods in each arm.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moderate (32.-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature
Time Frame: 1 hour after placement in warming device
Temperature taken via axilla for 1 minute duration
1 hour after placement in warming device
Moderate (32.0-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature
Time Frame: 6 hours after placement in warming device
Temperature taken via axilla for 1 minute duration
6 hours after placement in warming device
Moderate (32.-35.9° C) or Severe (<32.0°C) hypothermia per Axillary Temperature
Time Frame: 24 hours after placement in warming device
Temperature taken via axilla for 1 minute duration
24 hours after placement in warming device

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normothermia (Axillary temperature 36.0 - 38.0° C)
Time Frame: 1-96 hours after beginning of study
Temperature taken via axilla for 1 minute duration
1-96 hours after beginning of study
Hypothermia (Axillary temperature < 36.0° C)
Time Frame: 1-96 hours after beginning of study
Temperature taken via axilla for 1 minute duration
1-96 hours after beginning of study
Mean Axillary Temperature in each device
Time Frame: 4 months
Average of all axillary temperatures taken per device
4 months
Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device
Time Frame: 1 hour after placement in warming device
Temperature taken via axilla for 1 minute duration
1 hour after placement in warming device
Rate of Moderate hypothermia (32.0-35.9°C) after placement in warming device
Time Frame: 6 hours after placement in warming device
Temperature taken via axilla for 1 minute duration
6 hours after placement in warming device
Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device
Time Frame: 24 hours after placement in warming device
Temperature taken via axilla for 1 minute duration
24 hours after placement in warming device
Rate of Severe hypothermia (<32.0° C) after placement in warming device
Time Frame: 1 hour after placemnt in warming device
Temperature taken via axilla for 1 minute duration
1 hour after placemnt in warming device
Rate of Severe hypothermia (<32.0° C) after placement in warming device
Time Frame: 6 hours after placement in warming device
Temperature taken via axilla for 1 minute duration
6 hours after placement in warming device
Rate of Severe hypothermia (<32.0° C) after placement in warming device
Time Frame: 24 hours after placement in warming device
Temperature taken via axilla for 1 minute duration
24 hours after placement in warming device
Rate of Hyperthermia (>38.0°C) after placement in warming device
Time Frame: 4 months
Temperature taken via axilla for 1 minute duration
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Colm P Travers, MB BCh BAO, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2019

Primary Completion (Actual)

September 27, 2021

Study Completion (Actual)

September 27, 2021

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 14, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAB Neo 018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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