Clinical trial NCT02189746: Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants
Official title: A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia, Newborn
Keywords: Hypothermia
Newborn
Hyperthermia
Kangaroo mother care
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Axillary temperature < 36.0 degrees Celsius
timeFrame: Time of birth to 1 hour
measure: Axillary Temperature < 36.0 degrees Celsius
timeFrame: At discharge or 24 hours after birth (whichever is first)
Secondary outcomes:
measure: Blood pressure
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Blood glucose
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Seizure
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Respiratory Distress Syndrome (RDS)
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Sepsis
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Neonatal Intensive Care Unit Admission
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Death
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Any Axillary Temperature < 36.0 degrees Celsius
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Duration of Kangaroo Mother Care
timeFrame: Duration of hospitalization-expected average 4 weeks
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Manimaran Ramani, MD
role: PRINCIPAL_INVESTIGATOR
References: