ClinicalTrials.Veeva

Menu

Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Hypothermia, Newborn

Treatments

Other: Continuous Kangaroo Mother Care to discharge
Other: Continuous Kangaroo Mother Care to 1 hour after birth
Other: Standard Kangaroo Mother Care to discharge
Other: Standard Kangaroo Mother Care to 1 hour after birth

Study type

Interventional

Funder types

Other

Identifiers

NCT02189746
UAB Neo 011

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

1 minute to 8 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 4 patient groups

Continuous Kangaroo Mother Care to 1 hour after birth
Active Comparator group
Description:
In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from birth to one hour after birth.
Treatment:
Other: Continuous Kangaroo Mother Care to 1 hour after birth
Standard Kangaroo Mother Care to 1 hour after birth
Sham Comparator group
Description:
Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from birth to 1 hour after birth.
Treatment:
Other: Standard Kangaroo Mother Care to 1 hour after birth
Continuous Kangaroo Mother Care to discharge
Active Comparator group
Description:
In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from one hour after birth to discharge.
Treatment:
Other: Continuous Kangaroo Mother Care to discharge
Standard Kangaroo Mother Care to discharge
Sham Comparator group
Description:
Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from 1 hour after birth to discharge.
Treatment:
Other: Standard Kangaroo Mother Care to discharge

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems