- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03344978
Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial (CCot)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Investigators
- Principal Investigator: Colm P Travers, MB BCh BAO, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UAB Neo 018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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