Kangaroo Mother Care to Prevent Hypothermia in Term Infants

Hypothermia Clinical Trial

Official title:

A Randomized Trial of Kangaroo Mother Care to Prent Neonatal Hypothermia - Trials 2A & 2 B

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02189759
• Other study ID #: UAB Neo 012
• Status: Active, not recruiting
• Phase: N/A
• First received: July 11, 2014
• Last updated: January 29, 2016
• Start date: June 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardZambia: Research Ethics Committee
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2017
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia
• Newborn

Intervention

Other:
• Continuous Kangaroo Mother Care to one 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.
• Standard Kangaroo Mother Care to one 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.
• 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.
• 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.

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axillary temperature <36.0 degrees Celsius	Temperature taken per axilla for one minute	Time of birth to 1 hour	Yes
Primary	Axillary temperature < 36.0 degrees Celsius	Temperature taken per axilla for one minute	At discharge or 24 hours after birth (whichever is first)	Yes
Secondary	Blood pressure	Measure of extremity blood pressure per cuff taken during nursery stay	Duration of hospitalization--expected average of 2 weeks	Yes
Secondary	Blood glucose	Measure of blood glucose per laboratory value taken per heelstick	Duration of hospitalization-expected average of 2 weeks	Yes
Secondary	Seizure	Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.	Duration of hospitalization-expected average of 2 weeks	Yes
Secondary	Respiratory Distress	Documentation of increased work of breathing, retractions, and need for oxygen or intubation	Duration of Hospitalization-expected average 2 weeks	Yes
Secondary	Sepsis	Culture proven or culture negative clinically treated course consistent with sepsis	Duration of hospitalization-expected average of 2 weeks	Yes
Secondary	Neonatal Intensive Care Unit Admission	Any admission to the neonatal intensive care unit for higher level care	Duration of hospitalization-expected average of 2 weeks	Yes
Secondary	Death	Cardiorespiratory failure	Duration of hospitalization-expected average of 2 weeks	Yes
Secondary	Any Axillary Temperature <36.5 degrees Celsius	Temperature taken per axilla for one minute	Duration of hospitalization-expected average of 2 weeks	Yes
Secondary	Duration of Kangaroo Mother Care	Skin to skin contact between baby and mother	Duration of hospitalization-expected average of 2 weeks	No