Kangaroo Mother Care to Prevent Hypothermia in Term Infants

Not Applicable

Completed

• Conditions: Newborn; Hypothermia

• Registration Number: NCT02189759
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\<32.0 degrees C) in term infants (greater than or equal to 37 weeks of gestational age) when compared with routine WHO thermoregulation alone.

Detailed Description

The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, KMC whenever possible, early and exclusive breastfeeding, postponement of bathing and weighing, appropriate bundling, and use of air incubator, radiant warmer, or heat mattress if the neonate develops hypothermia) will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\<32.0 degrees C) in term infants (greater than or equal to weeks of gestational age) when compared with routine WHO thermoregulation alone.

Study Timeline

• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Study Start: 2014-08
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2017-02-17
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Results First Posted: 2017-06-19
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• Estimated gestational age greater than or equal to 37 weeks
• Delivery in the hospital

Exclusion Criteria

• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Infants With Axillary Temperature <36.0 Degrees Celsius	Time of birth to 1 hour	Temperature taken per axilla using digital thermometer
Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge	At discharge or 24 hours after birth (whichever is first)	Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth

Secondary Outcome Measures

Name	Time	Method
Number Infants Admitted to the Neonatal Intensive Care Unit	Duration of hospitalization-an average of 2 weeks	Any admission to the neonatal intensive care unit for higher level care
Duration of Kangaroo Mother Care	Duration of hospitalization-an average of 2 weeks	Skin to skin contact between baby and mother

Trial Locations

Locations (1)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia