Clinical trial NCT03344991: Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Official title: Cardboard Cot in Neonatal Thermoregulation: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infant, Premature
Keywords: Hypothermia
Newborn
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 24
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature
timeFrame: Up to 14 days
Secondary outcomes:
measure: Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature
timeFrame: Up to14 days
measure: Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots
timeFrame: 4 months
measure: Mean Axillary Temperatures on All Infants Weaned to Open Cribs
timeFrame: 4 months
measure: Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature
timeFrame: 1 hour after placement in warming device
measure: Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
timeFrame: 6 hours
measure: Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
timeFrame: 24 hours after placement in warming device
measure: Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
timeFrame: 1 hour after placement in warming device
measure: Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
timeFrame: 6 hours after placement in warming device
measure: Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
timeFrame: 24 hours after placement in warming device
measure: Rate of Hyperthemia (>38° C) measured by axillary temperature
timeFrame: 14 days
measure: Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature
timeFrame: Up to 14 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Colm P Travers, MB BCh BAO
role: PRINCIPAL_INVESTIGATOR
References: