MedTrace Logo

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

NCT03344991 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-10-26

No results posted yet for this study

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.

Conditions

  • Infant, Premature

Interventions

OTHER

Cardboard 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.

OTHER

Open 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 & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Colm P Travers, MB BCh BAO · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Hours
Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2021-09-27
Completion
2021-09-27

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344991 on ClinicalTrials.gov