Infant, Premature, Hypothermia, Newborn
Conditions
Keywords
Neonate, Premature, Hypothermia, Cardboard, Cot
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).
Interventions
OTHERCardboard 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.
OTHERIncubator 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 5 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderate (32.-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature | 1 hour after placement in warming device | Temperature taken via axilla for 1 minute duration |
| Moderate (32.0-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature | 6 hours after placement in warming device | Temperature taken via axilla for 1 minute duration |
| Moderate (32.-35.9° C) or Severe (<32.0°C) hypothermia per Axillary Temperature | 24 hours after placement in warming device | Temperature taken via axilla for 1 minute duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypothermia (Axillary temperature < 36.0° C) | 1-96 hours after beginning of study | Temperature taken via axilla for 1 minute duration |
| Mean Axillary Temperature in each device | 4 months | Average of all axillary temperatures taken per device |
| Rate of Hyperthermia (>38.0°C) after placement in warming device | 4 months | Temperature taken via axilla for 1 minute duration |
| Rate of Moderate hypothermia (32.0-35.9°C) after placement in warming device | 6 hours after placement in warming device | Temperature taken via axilla for 1 minute duration |
| Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device | 1 hour after placement in warming device | Temperature taken via axilla for 1 minute duration |
| Rate of Severe hypothermia (<32.0° C) after placement in warming device | 1 hour after placemnt in warming device | Temperature taken via axilla for 1 minute duration |
| Normothermia (Axillary temperature 36.0 - 38.0° C) | 1-96 hours after beginning of study | Temperature taken via axilla for 1 minute duration |
Outcome results
None listed