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

This study has been completed.
Sponsor:
Collaborator:
St.Luke's Life Science Institute, Tokyo, Japan
Information provided by (Responsible Party):
Shuko Nagai, Foundation for Advanced Studies on International Development
ClinicalTrials.gov Identifier:
NCT00531492
First received: September 17, 2007
Last updated: December 8, 2011
Last verified: December 2011

September 17, 2007
December 8, 2011
August 2007
September 2008   (final data collection date for primary outcome measure)
Mortality within 28 days after birth [ Time Frame: within 28 days after birth ] [ Designated as safety issue: Yes ]
Mortality within 28 days after birth [ Time Frame: within 28 days after birth ]
Complete list of historical versions of study NCT00531492 on ClinicalTrials.gov Archive Site
  • Mobility within 28 days after birth [ Time Frame: within 28 days after birth ] [ Designated as safety issue: Yes ]
  • Mortality and Mobility within 28 days after birth [ Time Frame: within 28 days after birth ] [ Designated as safety issue: Yes ]
  • Difference of (Baby's) loss in weight within 2 days [ Time Frame: within 2 days ] [ Designated as safety issue: Yes ]
  • Difference of (Baby's) Body weight of 14th day after birth [ Time Frame: 14th day after birth ] [ Designated as safety issue: Yes ]
  • Difference of (Baby's) Body weight of 28th day after birth [ Time Frame: 28th day after birth ] [ Designated as safety issue: Yes ]
  • Incidence of hypothermia during hospitalisation and (or) during outpatient department (lower than 35.5℃) [ Time Frame: Within 28 days after birth ] [ Designated as safety issue: Yes ]
  • Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min) [ Time Frame: within 28 days after birth ] [ Designated as safety issue: Yes ]
  • Incidence of apnea during hospitalisation (> 20 sec) [ Time Frame: within 28 days after birth ] [ Designated as safety issue: Yes ]
  • Incidence of desaturation during hospitalisation ( <87%) [ Time Frame: within 28 days after birth ] [ Designated as safety issue: Yes ]
  • Length of hospitalisation [ Time Frame: within 28 days after birth ] [ Designated as safety issue: No ]
  • Discharge within 7days after birth [ Time Frame: within 7days after birth ] [ Designated as safety issue: No ]
  • Mobility within 6 months or 1 year after birth [ Time Frame: within 6 months or 1 year ] [ Designated as safety issue: Yes ]
  • Mortality and Morbility within 6 months or 1 year after birth [ Time Frame: within 6 months or 1 year ] [ Designated as safety issue: Yes ]
  • Mortality within 6 months or 1 year after birth [ Time Frame: within 6 months or 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of hyperthermia during hospitalisation and (or) outpatient department (upper than 37.5℃) [ Time Frame: Within 28 days after birth ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Efficacy of Continuous Skin to Skin Care (Technique Kangaroo: TK) After Birth for Low Birth Weight (LBW) Infants and Their Mothers in Developing Countries
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 Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM), Madagascar

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Low Birth Weight
  • Behavioral: TK as soon as possible within 24 hours after birth
    Start TK as soon as possible within 24 hours after birth
  • Other: Conventional care
    Start conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)
  • Experimental: A
    Intervention: Behavioral: TK as soon as possible within 24 hours after birth
  • Active Comparator: B
    Intervention: Other: Conventional care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
March 2009
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Birth weight (BW) < 2500g
  • Delivery at maternity of CHUM (Birth < 24 hours)
  • Without serious congenital malformation
  • Sat O2 >=95%, HR > 100 / min, RR < 60 / min, Capillary refilling time < 3 sec
  • The mother and the family are motivated to practice TK.
  • The mother and the family available to practise TK should be healthy.

Exclusion Criteria:

  • Apnea of prematurity >20 sec
  • With intravenous infusion
Both
up to 24 Hours
No
Contact information is only displayed when the study is recruiting subjects
Madagascar
 
NCT00531492
FASID-06-CE-56
No
Shuko Nagai, Foundation for Advanced Studies on International Development
Foundation for Advanced Studies on International Development
St.Luke's Life Science Institute, Tokyo, Japan
Principal Investigator: Shuko Nagai, MD Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar
Foundation for Advanced Studies on International Development
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP