Kangaroo Mother Care to Prevent Hypothermia in Term Infants

The University of Alabama at Birmingham

Status: Completed

Conditions: Newborn; Hypothermia

Treatments: Other: Standard Kangaroo Mother Care to discharge; Other: Standard Kangaroo Mother Care to one hour after birth; Other: Continuous Kangaroo Mother Care to one hour after birth; Other: Continuous Kangaroo Mother Care to discharge

Study type: Interventional

Funder types: Other

Identifiers

NCT02189759

UAB Neo 012

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 term infants (greater than or equal to 37 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 term infants (greater than or equal to weeks of gestational age) when compared with routine WHO thermoregulation alone.

Enrollment: 375 patients

Sex: All

Ages: 1 minute to 2 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

375 participants in 4 patient groups

Continuous Kangaroo Mother Care to one 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 one hour after birth

Standard Kangaroo Mother Care to one 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 one 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