Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT02189746

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia, Newborn	Other: Continuous Kangaroo Mother Care to 1 hour after birth Other: Standard Kangaroo Mother Care to 1 hour after birth Other: Continuous Kangaroo Mother Care to discharge Other: Standard Kangaroo Mother Care to discharge	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Continuous Kangaroo Mother Care to 1 hour after birth 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 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.
Sham Comparator: Standard Kangaroo Mother Care to 1 hour after birth 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 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.
Active Comparator: Continuous Kangaroo Mother Care to discharge 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 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.
Sham Comparator: Standard Kangaroo Mother Care to discharge 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 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.

Outcome Measures

Primary Outcome Measures

Axillary temperature < 36.0 degrees Celsius [Time of birth to 1 hour]
Temperature taken per axilla for one minute
Axillary Temperature < 36.0 degrees Celsius [At discharge or 24 hours after birth (whichever is first)]
Temperature taken per axilla for one minute

Secondary Outcome Measures

Blood pressure [Duration of hospitalization-expected average of 4 weeks]
Measure of extremity blood pressure per cuff taken during nursery stay.
Blood glucose [Duration of hospitalization-expected average of 4 weeks]
Measure of blood glucose per laboratory value taken per heelstick
Seizure [Duration of hospitalization-expected average of 4 weeks]
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Respiratory Distress Syndrome (RDS) [Duration of hospitalization-expected average of 4 weeks]
Documentation of increased work of breathing, retractions, and need for oxygen, intubation or surfactant
Sepsis [Duration of hospitalization-expected average of 4 weeks]
Culture proven or culture negative clinically treated course consistent with sepsis
Neonatal Intensive Care Unit Admission [Duration of hospitalization-expected average of 4 weeks]
Any admission to NICU for need for higher level care
Death [Duration of hospitalization-expected average of 4 weeks]
Cardiorespiratory failure
Any Axillary Temperature < 36.0 degrees Celsius [Duration of hospitalization-expected average of 4 weeks]
Temperature taken per axilla for one minute
Duration of Kangaroo Mother Care [Duration of hospitalization-expected average 4 weeks]
Skin to skin contact between infant and mother

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Minute to 8 Weeks

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Teaching Hospital	Lusaka		Zambia

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Study Director: Waldemar A Carlo, MD, University of Alabama at Birmingham
Principal Investigator: Manimaran Ramani, MD, University of Alabama at Birmingham