Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants

NCT02189746 | Completed DMC

• 1 other identifier: UAB Neo 011
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia, Newborn

Keywords

Hypothermia; Newborn; Hyperthermia; Kangaroo mother care

Outcome Measures

Primary Outcomes (2)

• Axillary temperature < 36.0 degrees Celsius

  Temperature taken per axilla for one minute

  Time of birth to 1 hour

• Axillary Temperature < 36.0 degrees Celsius

  Temperature taken per axilla for one minute

  At discharge or 24 hours after birth (whichever is first)

Secondary Outcomes (9)

• Blood pressure

  Duration of hospitalization-expected average of 4 weeks

• Blood glucose

  Duration of hospitalization-expected average of 4 weeks

• Seizure

  Duration of hospitalization-expected average of 4 weeks

• Respiratory Distress Syndrome (RDS)

  Duration of hospitalization-expected average of 4 weeks

• Sepsis

  Duration of hospitalization-expected average of 4 weeks

Study Arms (4)

Continuous Kangaroo Mother Care to 1 hour after birth

ACTIVE COMPARATOR

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.

Other: Continuous Kangaroo Mother Care to 1 hour after birth

Standard Kangaroo Mother Care to 1 hour after birth

SHAM COMPARATOR

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.

Other: Standard Kangaroo Mother Care to 1 hour after birth

Continuous Kangaroo Mother Care to discharge

ACTIVE COMPARATOR

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.

Other: Continuous Kangaroo Mother Care to discharge

Standard Kangaroo Mother Care to discharge

SHAM COMPARATOR

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.

Other: Standard Kangaroo Mother Care to discharge

Interventions

Continuous Kangaroo Mother Care to 1 hour after birth OTHER

Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.

Continuous Kangaroo Mother Care to 1 hour after birth

Standard Kangaroo Mother Care to 1 hour after birth OTHER

Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\>38 degrees Celsius), the infant will receive standard care which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.

Standard Kangaroo Mother Care to 1 hour after birth

Continuous Kangaroo Mother Care to discharge OTHER

Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.

Continuous Kangaroo Mother Care to discharge

Standard Kangaroo Mother Care to discharge OTHER

Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\>38 degrees Celsius), standard treatment will be given which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.

Standard Kangaroo Mother Care to discharge

Eligibility Criteria

• Age: 1 Minute - 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Estimated gestational age 32-36 6/7 weeks
• Delivery in the hospital

You may not qualify if:

• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

MeSH Terms

Conditions

Hypothermia; Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Waldemar A Carlo, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

• Manimaran Ramani, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 15, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

ZA (1)