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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02189746
Date of registration:	11/07/2014
Prospective Registration:	No
Primary sponsor:	University of Alabama at Birmingham
Public title:	Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants
Scientific title:	A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B
Date of first enrolment:	June 2014
Target sample size:	140
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02189746
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Zambia

Contacts

Name:	Waldemar A Carlo, MD
Address:
Telephone:
Email:
Affiliation:	University of Alabama at Birmingham

Name:	Manimaran Ramani, MD
Address:
Telephone:
Email:
Affiliation:	University of Alabama at Birmingham

Key inclusion & exclusion criteria

Inclusion Criteria:

- Estimated gestational age 32-36 6/7 weeks

- Delivery in the hospital

Exclusion Criteria:

- Abdominal wall defect or myelomeningocele

- Major congenital anomalies

- Blistering skin disorder

Age minimum: N/A
Age maximum: 8 Weeks
Gender: All

Health Condition(s) or Problem(s) studied

Hypothermia, Newborn

Intervention(s)

Other: Continuous Kangaroo Mother Care to discharge

Other: Standard Kangaroo Mother Care to discharge

Other: Continuous Kangaroo Mother Care to 1 hour after birth

Other: Standard Kangaroo Mother Care to 1 hour after birth

Primary Outcome(s)

Axillary Temperature < 36.0 degrees Celsius [Time Frame: At discharge or 24 hours after birth (whichever is first)]

Axillary temperature < 36.0 degrees Celsius [Time Frame: Time of birth to 1 hour]

Secondary Outcome(s)

Any Axillary Temperature < 36.0 degrees Celsius [Time Frame: Duration of hospitalization-expected average of 4 weeks]

Sepsis [Time Frame: Duration of hospitalization-expected average of 4 weeks]

Blood glucose [Time Frame: Duration of hospitalization-expected average of 4 weeks]

Duration of Kangaroo Mother Care [Time Frame: Duration of hospitalization-expected average 4 weeks]

Blood pressure [Time Frame: Duration of hospitalization-expected average of 4 weeks]

Neonatal Intensive Care Unit Admission [Time Frame: Duration of hospitalization-expected average of 4 weeks]

Respiratory Distress Syndrome (RDS) [Time Frame: Duration of hospitalization-expected average of 4 weeks]

Seizure [Time Frame: Duration of hospitalization-expected average of 4 weeks]

Death [Time Frame: Duration of hospitalization-expected average of 4 weeks]

Secondary ID(s)

UAB Neo 011

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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