Clinical Trial: Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B

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 Summary: 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.
Sponsor: University of Alabama at Birmingham

Current Primary Outcome:

• Axillary temperature < 36.0 degrees Celsius [ Time Frame: Time of birth to 1 hour ]
  Temperature taken per axilla for one minute
• 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

Original Primary Outcome:

• Axillary temperature 36.5-37.5 degrees Celsius [ Time Frame: Time of birth to 1 hour ]
  Temperature taken per axilla for one minute
• Axillary Temperature 36.5-37.5 degrees Celsius [ Time Frame: At discharge or 24 hours after birth (whichever is first) ]
  Temperature taken per axilla for one minute

Current Secondary Outcome:

• Blood pressure [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Measure of extremity blood pressure per cuff taken during nursery stay.
• Blood glucose [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Measure of blood glucose per laboratory value taken per heelstick
• Seizure [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
• 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
• Sepsis [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Culture proven or culture negative clinically treated course consistent with sepsis
• 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
• Death [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Cardiorespiratory failure
• Any Axillary Temperature < 36.0 degrees Celsius [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Temperature taken per axilla for one minute
• Duration of Kangaroo Mother Care [ Time Frame: Duration of hospitalization-expected average 4 weeks ]
  Skin to skin contact between infant and mother

Original Secondary Outcome:

• Blood pressure [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Measure of extremity blood pressure per cuff taken during nursery stay.
• Blood glucose [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Measure of blood glucose per laboratory value taken per heelstick
• Seizure [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
• 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
• Sepsis [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Culture proven or culture negative clinically treated course consistent with sepsis
• NICU Admission [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Any admission to NICU for need for higher level care
• Death [ Time Frame: Duration of hospitalization-expected average of 4 weeks ]
  Cardiorespiratory failure

Information By: University of Alabama at Birmingham

Dates:
Date Received: July 11, 2014
Date Started: June 2014
Date Completion: December 2017
Last Updated: February 17, 2017
Last Verified: February 2017