Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants

Not Applicable

Completed

• Conditions: Hypothermia, Newborn

• Registration Number: NCT02189746
• 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 preterm infants (32-36 6/7 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 preterm infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation alone.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Axillary temperature < 36.0 degrees Celsius	Time of birth to 1 hour	Temperature taken per axilla for one minute
Axillary Temperature < 36.0 degrees Celsius	At discharge or 24 hours after birth (whichever is first)	Temperature taken per axilla for one minute

Secondary Outcome Measures

Name	Time	Method
Blood pressure	Duration of hospitalization-expected average of 4 weeks	Measure of extremity blood pressure per cuff taken during nursery stay.
Respiratory Distress Syndrome (RDS)	Duration of hospitalization-expected average of 4 weeks	Documentation of increased work of breathing, retractions, and need for oxygen, intubation or surfactant
Blood glucose	Duration of hospitalization-expected average of 4 weeks	Measure of blood glucose per laboratory value taken per heelstick
Seizure	Duration of hospitalization-expected average of 4 weeks	Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Sepsis	Duration of hospitalization-expected average of 4 weeks	Culture proven or culture negative clinically treated course consistent with sepsis
Neonatal Intensive Care Unit Admission	Duration of hospitalization-expected average of 4 weeks	Any admission to NICU for need for higher level care
Death	Duration of hospitalization-expected average of 4 weeks	Cardiorespiratory failure
Any Axillary Temperature < 36.0 degrees Celsius	Duration of hospitalization-expected average of 4 weeks	Temperature taken per axilla for one minute
Duration of Kangaroo Mother Care	Duration of hospitalization-expected average 4 weeks	Skin to skin contact between infant and mother

Trial Locations

Locations (1)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia