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Cardboard Cot Care for Neonatal Hypothermia (CCot Trial)

N/A
Waitlist Available
Led By Colm P Travers, MB BCh BAO
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Summary

This trial will determine if Mylar-lined cardboard cots are as effective as traditional incubators in preventing hypothermia in preterm neonates.

Eligible Conditions
  • Neonatal Hypothermia
  • Premature Infants

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Moderate (32.-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature
Moderate (32.-35.9° C) or Severe (<32.0°C) hypothermia per Axillary Temperature
Moderate (32.0-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature
Secondary outcome measures
Hypothermia (Axillary temperature < 36.0° C)
Mean Axillary Temperature in each device
Normothermia (Axillary temperature 36.0 - 38.0° C)
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Cardboard Cot CareActive Control1 Intervention
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.
Group II: Incubator CarePlacebo Group1 Intervention
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.

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,920 Total Patients Enrolled
Colm P Travers, MB BCh BAOPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
25 Total Patients Enrolled
~0 spots leftby Sep 2025
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