Back to resultsKangaroo Mother Care to Prevent Hypothermia in Preterm Infants
Primary Purpose
Hypothermia, Newborn
Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Continuous Kangaroo Mother Care to 1 hour after birth
Standard Kangaroo Mother Care to 1 hour after birth
Continuous Kangaroo Mother Care to discharge
Standard Kangaroo Mother Care to discharge
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia, Newborn focused on measuring Hypothermia, Newborn, Hyperthermia, Kangaroo mother care
Eligibility 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
Sites / Locations
- University Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Sham Comparator
Active Comparator
Sham Comparator
Arm Label
Continuous Kangaroo Mother Care to 1 hour after birth
Standard Kangaroo Mother Care to 1 hour after birth
Continuous Kangaroo Mother Care to discharge
Standard Kangaroo Mother Care to discharge
Arm 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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Axillary temperature < 36.0 degrees Celsius
Temperature taken per axilla for one minute
Axillary Temperature < 36.0 degrees Celsius
Temperature taken per axilla for one minute
Secondary Outcome Measures
Blood pressure
Measure of extremity blood pressure per cuff taken during nursery stay.
Blood glucose
Measure of blood glucose per laboratory value taken per heelstick
Seizure
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Respiratory Distress Syndrome (RDS)
Documentation of increased work of breathing, retractions, and need for oxygen, intubation or surfactant
Sepsis
Culture proven or culture negative clinically treated course consistent with sepsis
Neonatal Intensive Care Unit Admission
Any admission to NICU for need for higher level care
Death
Cardiorespiratory failure
Any Axillary Temperature < 36.0 degrees Celsius
Temperature taken per axilla for one minute
Duration of Kangaroo Mother Care
Skin to skin contact between infant and mother
Full Information
NCT ID
NCT02189746
First Posted
July 11, 2014
Last Updated
January 8, 2018
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT02189746
Brief Title
Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants
Official Title
A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Newborn
Keywords
Hypothermia, Newborn, Hyperthermia, Kangaroo mother care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Kangaroo Mother Care to 1 hour after birth
Arm Type
Active Comparator
Arm 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.
Arm Title
Standard Kangaroo Mother Care to 1 hour after birth
Arm Type
Sham Comparator
Arm 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.
Arm Title
Continuous Kangaroo Mother Care to discharge
Arm Type
Active Comparator
Arm 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.
Arm Title
Standard Kangaroo Mother Care to discharge
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Continuous Kangaroo Mother Care to 1 hour after birth
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Kangaroo Mother Care to 1 hour after birth
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Continuous Kangaroo Mother Care to discharge
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Kangaroo Mother Care to discharge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Axillary temperature < 36.0 degrees Celsius
Description
Temperature taken per axilla for one minute
Time Frame
Time of birth to 1 hour
Title
Axillary Temperature < 36.0 degrees Celsius
Description
Temperature taken per axilla for one minute
Time Frame
At discharge or 24 hours after birth (whichever is first)
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Measure of extremity blood pressure per cuff taken during nursery stay.
Time Frame
Duration of hospitalization-expected average of 4 weeks
Title
Blood glucose
Description
Measure of blood glucose per laboratory value taken per heelstick
Time Frame
Duration of hospitalization-expected average of 4 weeks
Title
Seizure
Description
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Time Frame
Duration of hospitalization-expected average of 4 weeks
Title
Respiratory Distress Syndrome (RDS)
Description
Documentation of increased work of breathing, retractions, and need for oxygen, intubation or surfactant
Time Frame
Duration of hospitalization-expected average of 4 weeks
Title
Sepsis
Description
Culture proven or culture negative clinically treated course consistent with sepsis
Time Frame
Duration of hospitalization-expected average of 4 weeks
Title
Neonatal Intensive Care Unit Admission
Description
Any admission to NICU for need for higher level care
Time Frame
Duration of hospitalization-expected average of 4 weeks
Title
Death
Description
Cardiorespiratory failure
Time Frame
Duration of hospitalization-expected average of 4 weeks
Title
Any Axillary Temperature < 36.0 degrees Celsius
Description
Temperature taken per axilla for one minute
Time Frame
Duration of hospitalization-expected average of 4 weeks
Title
Duration of Kangaroo Mother Care
Description
Skin to skin contact between infant and mother
Time Frame
Duration of hospitalization-expected average 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waldemar A Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manimaran Ramani, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Teaching Hospital
City
Lusaka
Country
Zambia
12. IPD Sharing Statement
Learn more about this trial
Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants
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