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
  Purpose

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.


Condition Intervention
Low Birth Weight
Behavioral: TK as soon as possible within 24 hours after birth
Other: Conventional care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM), Madagascar

Resource links provided by NLM:


Further study details as provided by Foundation for Advanced Studies on International Development:

Primary Outcome Measures:
  • Mortality within 28 days after birth [ Time Frame: within 28 days after birth ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 73
Study Start Date: August 2007
Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Behavioral: TK as soon as possible within 24 hours after birth
Start TK as soon as possible within 24 hours after birth
Active Comparator: B Other: Conventional care
Start conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531492

Locations
Madagascar
University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM),
Mahajanga, Madagascar
Sponsors and Collaborators
Foundation for Advanced Studies on International Development
St.Luke's Life Science Institute, Tokyo, Japan
Investigators
Principal Investigator: Shuko Nagai, MD Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar
  More Information

Publications:
Responsible Party: Shuko Nagai, Groupe d'Etude de la Technique Kangourouà, Foundation for Advanced Studies on International Development
ClinicalTrials.gov Identifier: NCT00531492     History of Changes
Other Study ID Numbers: FASID-06-CE-56
Study First Received: September 17, 2007
Last Updated: December 8, 2011
Health Authority: Madagascar: Ministry of Health

Keywords provided by Foundation for Advanced Studies on International Development:
Maternal and child health
Developing country
Skin to skin care
Newly born low birth weight infants and their mothers
(Delivery at University Hospital Center, Mahajanga, Madagascar)

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014