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Kangaroo Mother Care to Prevent Hypothermia in Term Infants

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypothermia; Newborn

Intervention: Continuous Kangaroo Mother Care to one hour after birth (Other); Standard Kangaroo Mother Care to one hour after birth (Other); Continuous Kangaroo Mother Care to discharge (Other); Standard Kangaroo Mother Care to discharge (Other)

Phase: N/A

Status: Recruiting

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Waldemar A Carlo, MD, Study Director, Affiliation: University of Alabama at Birmingham
Manimaran Ramani, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham

Overall contact:
Manimaran Ramani, MD, Phone: 205 934-4680, Email: mramani@peds.uab.edu

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.

Clinical Details

Official title: A Randomized Trial of Kangaroo Mother Care to Prent Neonatal Hypothermia - Trials 2A & 2 B

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Axillary temperature <36.0 degrees Celsius

Axillary temperature < 36.0 degrees Celsius

Secondary outcome:

Blood pressure

Blood glucose

Seizure

Respiratory Distress

Sepsis

Neonatal Intensive Care Unit Admission

Death

Any Axillary Temperature <36.5 degrees Celsius

Duration of Kangaroo Mother Care

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.

Eligibility

Minimum age: N/A. Maximum age: 2 Weeks. Gender(s): Both.

Criteria:

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

Locations and Contacts

Manimaran Ramani, MD, Phone: 205 934-4680, Email: mramani@peds.uab.edu

University Teaching Hospital, Lusaka, Zambia; Recruiting
Musaku Mwenechanya, MD
Elwyn Chomba, MD
Musaku Mwenechanya, MD, Sub-Investigator
Elwyn Chomba, MD, Sub-Investigator
Additional Information

Starting date: June 2014
Last updated: February 16, 2015

Page last updated: August 23, 2015

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