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Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189746


Locations
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Zambia
University Teaching Hospital
Lusaka, Zambia
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Study Director: Waldemar A Carlo, MD University of Alabama at Birmingham
Principal Investigator: Manimaran Ramani, MD University of Alabama at Birmingham
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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    Key Record Dates
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:
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Hypothermia
Body Temperature Changes
Signs and Symptoms