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 CelsiusAxillary temperature < 36.0 degrees Celsius
Secondary outcome: Blood pressureBlood 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
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