Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial

NCT03344978 | Withdrawn

• 1 other identifier: UAB Neo 018
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Neonate; Premature; Hypothermia; Cardboard; Cot

Outcome Measures

Primary Outcomes (3)

• Moderate (32.-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature

  Temperature taken via axilla for 1 minute duration

  1 hour after placement in warming device

• Moderate (32.0-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature

  Temperature taken via axilla for 1 minute duration

  6 hours after placement in warming device

• Moderate (32.-35.9° C) or Severe (<32.0°C) hypothermia per Axillary Temperature

  Temperature taken via axilla for 1 minute duration

  24 hours after placement in warming device

Secondary Outcomes (10)

• Normothermia (Axillary temperature 36.0 - 38.0° C)

  1-96 hours after beginning of study

• Hypothermia (Axillary temperature < 36.0° C)

  1-96 hours after beginning of study

• Mean Axillary Temperature in each device

  4 months

• Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device

  1 hour after placement in warming device

• Rate of Moderate hypothermia (32.0-35.9°C) after placement in warming device

  6 hours after placement in warming device

Study Arms (2)

Cardboard Cot Care

ACTIVE COMPARATOR

Stable infant will be nursed in a cardboard cot, lined with reflective film for 24 hour period of time. Infant's axillary temperature will be taken at 1 hour after randomization, at 6 hours after randomization, and 24 hours after randomization. After 24 hours, infant will be swapped to the other arm (Incubator Care), and back for a total of 2 24-hour periods in each arm.

Other: Cardboard Cot Care

Incubator Care

PLACEBO COMPARATOR

Stable infant will be nursed in an incubator for 24 hour period of time. Infant's axillary temperature will be taken at 1 hour after randomization, at 6 hours after randomization, and 24 hours after randomization. After 24 hours, infant will be swapped to the other arm (Cardboard Cot Care), and back for a total of 2 24-hour periods in each arm.

Other: Incubator Care

Interventions

Cardboard Cot Care OTHER

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.

Also known as: CCot

Cardboard Cot Care

Incubator Care OTHER

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.

Incubator Care

Eligibility Criteria

• Age: 1 Minute - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Estimated gestational age \< 36 6/7 weeks
• Hospitalized in the NICU at University Teaching Hospital in Zambia
• Requiring incubator/radiant warmer for at least 1 week

You may not qualify if:

• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder
• Suspected Sepsis
• Requiring ongoing respiratory support

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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized crossover. Participant will be randomly assigned initially to care in one of two devices for 24 hours, then crossed over to other device for 24 hours. This will be repeated once more for a total of 96 hours study time. Patterns may be A-B-A-B or B-A-B-A.

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