Infant, Premature
Conditions
Keywords
Hypothermia, Newborn
Brief summary
Infants with an estimated gestational age \< 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are delivered in a setting where an incubator is not available, will be randomized to either standard protocol of open crib or mylar-lined cardboard cot for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care.
Detailed description
Following parental consent, preterm infants with an estimated gestational age \< 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are in the newborn ICU in a setting where an incubator is not available, will be randomized to to transfer either standard protocol of open crib or mylar-lined cardboard cot when their temperatures are stable for transfer. The infants will remain in the cot or crib for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care, including WHO warm chain thermoregulation guidelines of early and exclusive breastfeeding, appropriate bundling and Kangaroo Mother Care as continuously as possible. If at any point a babies becomes moderately (32.0-35.9° C) or severely hypothermic (\< 32.0° C), an extra blanket will be added to their bodies and a hat placed on their heads.
Interventions
OTHERCardboard Cot Care
When ready to be weaned from radiant warmer, infant will be placed in a reflective film-lined cot for the duration of hospitalization. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge. If temperatures found \< 36.0 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 early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
OTHEROpen Crib
When ready to be weaned from radiant warmer, infant will be placed in a standard of care open crib for the duration of hospitalization. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge. If temperatures found \< 36.0 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 early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Infants will be randomized to either open crib (standard of care) or mylar-lined cardboard box following care in a radiant warmer
Eligibility
Sex/Gender
ALL
Age
24 Hours to 2 Weeks
Healthy volunteers
No
Inclusion criteria
* Estimated gestational age \< 36 6/7 weeks * Hospitalized in the newborn ICU at University Teaching Hospital * Nursed in an incubator for at least 24 hours * Thought to be ready to be weaned from incubator by the clinical staff
Exclusion criteria
* Major congenital anomalies * Requiring ongoing respiratory support * Suspected sepsis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature | Up to 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Mean Axillary Temperatures on All Infants Weaned to Open Cribs | 4 months |
| Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature | Up to14 days |
| Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature | 1 hour after placement in warming device |
| Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots | 4 months |
| Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature | 1 hour after placement in warming device |
| Rate of Hyperthemia (>38° C) measured by axillary temperature | 14 days |
| Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature | Up to 14 days |
| Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature | 6 hours |
Outcome results
None listed