Clinical Trial: Efficacy of Continuous Skin to Skin Care (Technique Kangaroo: TK) After Birth for Low Birth Weight (LBW) Infants and Their Mothers in Developing Countries

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial of Continuous Skin to Skin Care (Technique Kangourou: TK) for Low Birth Weight (LBW) Infants and Their Mothers at University Hospital Center of

Brief Summary:

The purpose of this study is to examine the efficacy of Technique Kangourou (TK) between low birth weight (LBW) infants and their mothers started as soon as possible within 24 hours after birth in developing country.

For the purpose of this study, TK is defined as skin-to-skin direct and continuous (24 hours) contact between LBW infants and their mothers or any other people who substitute mothers.


Detailed Summary:
Sponsor: Foundation for Advanced Studies on International Development

Current Primary Outcome: Mortality within 28 days after birth [ Time Frame: within 28 days after birth ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mobility within 28 days after birth [ Time Frame: within 28 days after birth ]
  • Mortality and Mobility within 28 days after birth [ Time Frame: within 28 days after birth ]
  • Difference of (Baby's) loss in weight within 2 days [ Time Frame: within 2 days ]
  • Difference of (Baby's) Body weight of 14th day after birth [ Time Frame: 14th day after birth ]
  • Difference of (Baby's) Body weight of 28th day after birth [ Time Frame: 28th day after birth ]
  • Incidence of hypothermia during hospitalisation and (or) during outpatient department （lower than 35.5℃） [ Time Frame: Within 28 days after birth ]
  • Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min) [ Time Frame: within 28 days after birth ]
  • Incidence of apnea during hospitalisation (> 20 sec) [ Time Frame: within 28 days after birth ]
  • Incidence of desaturation during hospitalisation ( <87%) [ Time Frame: within 28 days after birth ]
  • Length of hospitalisation [ Time Frame: within 28 days after birth ]
  • Discharge within 7days after birth [ Time Frame: within 7days after birth ]
  • Mobility within 6 months or 1 year after birth [ Time Frame: within 6 months or 1 year ]
  • Mortality and Morbility within 6 months or 1 year after birth [ Time Frame: within 6 months or 1 year ]
  • Mortality within 6 months or 1 year after birth [ Time Frame: within 6 months or 1 year ]
  • Incidence of hyperthermia during hospitalisation and (or) outpatient department （upper than 37.5℃） [ Time Frame: Within 28 days after birth ]


Original Secondary Outcome:

  • Mobility within 28 days after birth [ Time Frame: within 28 days after birth ]
  • Mortality and Mobility within 28 days after birth [ Time Frame: within 28 days after birth ]
  • Difference of (Baby's) loss in weight within 2 days [ Time Frame: within 2 days ]
  • Difference of (Baby's) Body weight of 14th day after birth [ Time Frame: 14th day after birth ]
  • Difference of (Baby's) Body weight of 28th day after birth [ Time Frame: 28th day after birth ]
  • Incidence of hypothermia during hospitalisation（lower than 35.5℃） [ Time Frame: Within 28 days after birth ]
  • Incidence of bradycardia or tachycardia during hospitlisation (HR <100, or>180 /min) [ Time Frame: within 28 days after birth ]
  • Incidence of apnea during hospitalisation (> 20 sec) [ Time Frame: during hospitalisation ]
  • Incidence of desaturation during hospitalisation ( <87%) [ Time Frame: during hospitalisation ]
  • Length of hospitalisation [ Time Frame: During hospitalisation ]
  • Discharge within 7days after birth [ Time Frame: within 7days after birth ]


Information By: Foundation for Advanced Studies on International Development

Dates:
Date Received: September 17, 2007
Date Started: August 2007
Date Completion:
Last Updated: December 8, 2011
Last Verified: December 2011