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Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial

NCT03344978 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-10-26

No results posted yet for this study

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.

Conditions

  • Infant, Premature
  • Hypothermia, Newborn

Interventions

OTHER

Cardboard 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.

OTHER

Incubator 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 & 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
CROSSOVER

Eligibility

Min Age
1 Minute
Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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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 NCT03344978 on ClinicalTrials.gov