NCT00531492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

December 12, 2011

Status Verified

December 1, 2011

Enrollment Period

1.1 years

First QC Date

September 17, 2007

Last Update Submit

December 8, 2011

Conditions

Low Birth Weight

Keywords

Maternal and child healthDeveloping countrySkin to skin careNewly born low birth weight infants and their mothers(Delivery at University Hospital Center, Mahajanga, Madagascar)

Outcome Measures

Primary Outcomes (1)

  • Mortality within 28 days after birth

    within 28 days after birth

Secondary Outcomes (15)

  • Mobility within 28 days after birth

    within 28 days after birth

  • Mortality and Mobility within 28 days after birth

    within 28 days after birth

  • Difference of (Baby's) loss in weight within 2 days

    within 2 days

  • Difference of (Baby's) Body weight of 14th day after birth

    14th day after birth

  • Difference of (Baby's) Body weight of 28th day after birth

    28th day after birth

  • +10 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Behavioral: TK as soon as possible within 24 hours after birth

B

ACTIVE COMPARATOR
Other: Conventional care

Interventions

TK as soon as possible within 24 hours after birthBEHAVIORAL

Start TK as soon as possible within 24 hours after birth

A
Conventional careOTHER

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

B

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Apnea of prematurity \>20 sec
  • With intravenous infusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mahajanga, Mahajanga, Madagascar

Location

Related Publications (2)

  • 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.

    PMID: 20121708RESULT

  • 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.

    PMID: 21635363RESULT

Study Officials

  • Shuko Nagai, MD

    Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Groupe d'Etude de la Technique Kangourouà

Study Record Dates

First Submitted

September 17, 2007

First Posted

September 18, 2007

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Study Completion

March 1, 2009

Last Updated

December 12, 2011

Record last verified: 2011-12

Locations

MA(1)