- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02189746
Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants
January 8, 2018 updated by: Manimaran Ramani, MD, University of Alabama at Birmingham
A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lusaka, Zambia
- University Teaching Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 minute to 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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.
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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.
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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.
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Axillary temperature < 36.0 degrees Celsius
Time Frame: Time of birth to 1 hour
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Temperature taken per axilla for one minute
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Time of birth to 1 hour
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Axillary Temperature < 36.0 degrees Celsius
Time Frame: At discharge or 24 hours after birth (whichever is first)
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Temperature taken per axilla for one minute
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At discharge or 24 hours after birth (whichever is first)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Duration of hospitalization-expected average of 4 weeks
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Measure of extremity blood pressure per cuff taken during nursery stay.
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Duration of hospitalization-expected average of 4 weeks
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Blood glucose
Time Frame: Duration of hospitalization-expected average of 4 weeks
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Measure of blood glucose per laboratory value taken per heelstick
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Duration of hospitalization-expected average of 4 weeks
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Seizure
Time Frame: Duration of hospitalization-expected average of 4 weeks
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Seizure activity diagnosed by medical doctor or nurse.
No electroencephalogram will be done.
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Duration of hospitalization-expected average of 4 weeks
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Respiratory Distress Syndrome (RDS)
Time Frame: Duration of hospitalization-expected average of 4 weeks
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Documentation of increased work of breathing, retractions, and need for oxygen, intubation or surfactant
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Duration of hospitalization-expected average of 4 weeks
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Sepsis
Time Frame: Duration of hospitalization-expected average of 4 weeks
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Culture proven or culture negative clinically treated course consistent with sepsis
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Duration of hospitalization-expected average of 4 weeks
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Neonatal Intensive Care Unit Admission
Time Frame: Duration of hospitalization-expected average of 4 weeks
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Any admission to NICU for need for higher level care
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Duration of hospitalization-expected average of 4 weeks
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Death
Time Frame: Duration of hospitalization-expected average of 4 weeks
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Cardiorespiratory failure
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Duration of hospitalization-expected average of 4 weeks
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Any Axillary Temperature < 36.0 degrees Celsius
Time Frame: Duration of hospitalization-expected average of 4 weeks
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Temperature taken per axilla for one minute
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Duration of hospitalization-expected average of 4 weeks
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Duration of Kangaroo Mother Care
Time Frame: Duration of hospitalization-expected average 4 weeks
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Skin to skin contact between infant and mother
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Duration of hospitalization-expected average 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Manimaran Ramani, MD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
July 11, 2014
First Submitted That Met QC Criteria
July 11, 2014
First Posted (Estimate)
July 15, 2014
Study Record Updates
Last Update Posted (Actual)
January 10, 2018
Last Update Submitted That Met QC Criteria
January 8, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UAB Neo 011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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