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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	1 November 2021
Main ID:	NCT03344978
Date of registration:	14/11/2017
Prospective Registration:	Yes
Primary sponsor:	University of Alabama at Birmingham
Public title:	Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial CCot
Scientific title:	Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial in Prevention of Moderate or Severe Hypothermia in Preterm Infants Requiring at Least 1 Week of Incubator
Date of first enrolment:	June 11, 2019
Target sample size:	0
Recruitment status:	Withdrawn
URL:	https://clinicaltrials.gov/show/NCT03344978
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
United States	Zambia

Contacts

Name:	Colm P Travers, MB BCh BAO
Address:
Telephone:
Email:
Affiliation:	University of Alabama at Birmingham

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- Abdominal wall defect or myelomeningocele

- Major congenital anomalies

- Blistering skin disorder

- Suspected Sepsis

- Requiring ongoing respiratory support

Age minimum: N/A
Age maximum: 5 Days
Gender: All

Health Condition(s) or Problem(s) studied

Infant, Premature

Hypothermia, Newborn

Intervention(s)

Other: Cardboard Cot Care

Other: Incubator Care

Primary Outcome(s)

Moderate (32.-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature [Time Frame: 1 hour after placement in warming device]

Moderate (32.-35.9° C) or Severe (<32.0°C) hypothermia per Axillary Temperature [Time Frame: 24 hours after placement in warming device]

Moderate (32.0-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature [Time Frame: 6 hours after placement in warming device]

Secondary Outcome(s)

Normothermia (Axillary temperature 36.0 - 38.0° C) [Time Frame: 1-96 hours after beginning of study]

Rate of Hyperthermia (>38.0°C) after placement in warming device [Time Frame: 4 months]

Rate of Severe hypothermia (<32.0° C) after placement in warming device [Time Frame: 6 hours after placement in warming device]

Hypothermia (Axillary temperature < 36.0° C) [Time Frame: 1-96 hours after beginning of study]

Mean Axillary Temperature in each device [Time Frame: 4 months]

Rate of Moderate hypothermia (32.0-35.9°C) after placement in warming device [Time Frame: 6 hours after placement in warming device]

Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device [Time Frame: 1 hour after placement in warming device]

Rate of Severe hypothermia (<32.0° C) after placement in warming device [Time Frame: 1 hour after placemnt in warming device]

Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device [Time Frame: 24 hours after placement in warming device]

Rate of Severe hypothermia (<32.0° C) after placement in warming device [Time Frame: 24 hours after placement in warming device]

Secondary ID(s)

UAB Neo 018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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