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

NCT03344991 | Withdrawn

• 1 other identifier: UAB Neo 019
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infant, Premature

Keywords

Hypothermia; Newborn

Outcome Measures

Primary Outcomes (1)

• Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature

  Up to 14 days

Secondary Outcomes (11)

• Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature

  Up to14 days

• Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots

  4 months

• Mean Axillary Temperatures on All Infants Weaned to Open Cribs

  4 months

• Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature

  1 hour after placement in warming device

• Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature

  6 hours

Study Arms (2)

Cardboard Cot Care

ACTIVE COMPARATOR

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.

Other: Cardboard Cot Care

Open Crib

PLACEBO COMPARATOR

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.

Other: Open Crib

Interventions

Cardboard Cot Care OTHER

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.

Cardboard Cot Care

Open Crib OTHER

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.

Open Crib

Eligibility Criteria

• Age: 24 Hours - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Major congenital anomalies
• Requiring ongoing respiratory support
• Suspected sepsis

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Premature Birth; Hypothermia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Colm P Travers, MB BCh BAO

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Infants will be randomized to either open crib (standard of care) or mylar-lined cardboard box following care in a radiant warmer

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: June 11, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share