Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/16/2018 |
| Start Date: | June 30, 2019 |
| End Date: | May 31, 2021 |
| Contact: | Colm P Travers, MB BCh BAO |
| Email: | ctravers@peds.uab.edu |
| Phone: | 205-934-4680 |
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.
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.
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).
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).
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
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