Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib

The University of Alabama at Birmingham

Status: Withdrawn

Conditions: Infant, Premature

Treatments: Other: Open Crib; Other: Cardboard Cot Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03344991

UAB Neo 019

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 24 hours to 2 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Cardboard Cot Care

Active Comparator group

Description:

Stable infant will be transferred to cardboard cot, lined with reflective film for duration of hospital stay following weaning from radiant warmer. Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.

Treatment:

Other: Cardboard Cot Care

Open Crib

Placebo Comparator group

Description:

Stable infant will be transferred to standard of care open crib for duration of hospital stay following weaning from radiant warmer. Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.

Treatment:

Other: Open Crib