Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants

• ClinicalTrials.gov Identifier: NCT02189746
• Recruitment Status: Completed
• First Posted: July 15, 2014
• Last Update Posted: January 10, 2018
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Manimaran Ramani, MD, University of Alabama at Birmingham

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	Not Applicable

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 (Clinical Trial)
• 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: June 2014
• Actual Primary Completion Date: August 2017
• Actual Study Completion Date: August 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 :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: up to 8 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Zambia

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

More Information

• Responsible Party: Manimaran Ramani, MD, Assistant Professor of Pediatrics, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02189746
• Other Study ID Numbers: UAB Neo 011
• First Posted: July 15, 2014
• Last Update Posted: January 10, 2018
• Last Verified: January 2018

Keywords provided by Manimaran Ramani, MD, University of Alabama at Birmingham:

Hypothermia; Newborn; Hyperthermia; Kangaroo mother care

Additional relevant MeSH terms:

Hypothermia; Body Temperature Changes; Signs and Symptoms