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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)

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ClinicalTrials.gov Identifier: NCT00531492
Recruitment Status : Completed
First Posted : September 18, 2007
Last Update Posted : December 12, 2011
Sponsor:
Collaborator:
St.Luke's Life Science Institute, Tokyo, Japan
Information provided by (Responsible Party):
Shuko Nagai, Foundation for Advanced Studies on International Development

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.


Condition or disease Intervention/treatment Phase
Low Birth Weight Behavioral: TK as soon as possible within 24 hours after birth Other: Conventional care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Mortality within 28 days after birth [ Time Frame: within 28 days after birth ]

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


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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
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

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): 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

Publications of Results:
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
First Posted: September 18, 2007    Key Record Dates
Last Update Posted: December 12, 2011
Last Verified: December 2011

Keywords provided by Shuko Nagai, 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:
Body Weight
Birth Weight
Signs and Symptoms