Clinical trial NCT03344978: Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infant, Premature
Hypothermia, Newborn
Keywords: Neonate
Premature
Hypothermia
Cardboard
Cot
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover. Participant will be randomly assigned initially to care in one of two devices for 24 hours, then crossed over to other device for 24 hours. This will be repeated once more for a total of 96 hours study time. Patterns may be A-B-A-B or B-A-B-A.
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Moderate (32.-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature
timeFrame: 1 hour after placement in warming device
measure: Moderate (32.0-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature
timeFrame: 6 hours after placement in warming device
measure: Moderate (32.-35.9° C) or Severe (<32.0°C) hypothermia per Axillary Temperature
timeFrame: 24 hours after placement in warming device
Secondary outcomes:
measure: Normothermia (Axillary temperature 36.0 - 38.0° C)
timeFrame: 1-96 hours after beginning of study
measure: Hypothermia (Axillary temperature < 36.0° C)
timeFrame: 1-96 hours after beginning of study
measure: Mean Axillary Temperature in each device
timeFrame: 4 months
measure: Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device
timeFrame: 1 hour after placement in warming device
measure: Rate of Moderate hypothermia (32.0-35.9°C) after placement in warming device
timeFrame: 6 hours after placement in warming device
measure: Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device
timeFrame: 24 hours after placement in warming device
measure: Rate of Severe hypothermia (<32.0° C) after placement in warming device
timeFrame: 1 hour after placemnt in warming device
measure: Rate of Severe hypothermia (<32.0° C) after placement in warming device
timeFrame: 6 hours after placement in warming device
measure: Rate of Severe hypothermia (<32.0° C) after placement in warming device
timeFrame: 24 hours after placement in warming device
measure: Rate of Hyperthermia (>38.0°C) after placement in warming device
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Colm P Travers, MB BCh BAO
role: PRINCIPAL_INVESTIGATOR
References: