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

NCT ID: NCT00531492

Last Updated: 2011-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-03-31

Brief Summary

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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 Description

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Conditions

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Low Birth Weight

Keywords

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

TK as soon as possible within 24 hours after birth

Intervention Type BEHAVIORAL

Start TK as soon as possible within 24 hours after birth

B

Group Type ACTIVE_COMPARATOR

Conventional care

Intervention Type OTHER

Start conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)

Interventions

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TK as soon as possible within 24 hours after birth

Start TK as soon as possible within 24 hours after birth

Intervention Type BEHAVIORAL

Conventional care

Start conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St.Luke's Life Science Institute, Tokyo, Japan

UNKNOWN

Sponsor Role collaborator

Foundation for Advanced Studies on International Development

OTHER

Sponsor Role lead

Responsible Party

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Shuko Nagai

Groupe d'Etude de la Technique Kangourouà

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuko Nagai, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar

Locations

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University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM),

Mahajanga, Mahajanga, Madagascar

Site Status

Countries

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Madagascar

References

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Nagai S, Andrianarimanana D, Rabesandratana N, Yonemoto N, Nakayama T, Mori R. Earlier versus later continuous Kangaroo Mother Care (KMC) for stable low-birth-weight infants: a randomized controlled trial. Acta Paediatr. 2010 Jun;99(6):827-35. doi: 10.1111/j.1651-2227.2009.01676.x. Epub 2010 Jan 27.

Reference Type RESULT
PMID: 20121708 (View on PubMed)

Nagai S, Yonemoto N, Rabesandratana N, Andrianarimanana D, Nakayama T, Mori R. Long-term effects of earlier initiated continuous Kangaroo Mother Care (KMC) for low-birth-weight (LBW) infants in Madagascar. Acta Paediatr. 2011 Dec;100(12):e241-7. doi: 10.1111/j.1651-2227.2011.02372.x. Epub 2011 Jun 23.

Reference Type RESULT
PMID: 21635363 (View on PubMed)

Other Identifiers

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FASID-06-CE-56

Identifier Type: -

Identifier Source: org_study_id