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CompletedNCT00531492EtudeTKUpdated Dec 12, 2011

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

An interventional study of TK as soon as possible within 24 hours after birth and Conventional care in Low Birth Weight, sponsored by Foundation for Advanced Studies on International Development. Completed at 1 site in Madagascar. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2011-12-12.

Sponsored by Foundation for Advanced Studies on International Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
Up to 24 Hours
Sex
All
01

Study 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.

02

Conditions studied

  • Low Birth Weight

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Keywords

  • 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)
03

In context

Birth Weight

185 studies on the registry are indexed under Birth Weight; 25 are open to participants now.

This study's enrollment of 73 is below the median of 170 across 117 interventional studies indexed under Birth Weight.

Browse Birth Weight studies →

Lead sponsor

This is the only study on the registry with Foundation for Advanced Studies on International Development as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 24 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Apnea of prematurity >20 sec
  • With intravenous infusion
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    A

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

  • Active comparator
    B

    Other: Conventional care

Interventions

  • BehavioralTK as soon as possible within 24 hours after birth

    Start TK as soon as possible within 24 hours after birth

  • OtherConventional care

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

06

What researchers measure

Primary outcomes

  1. Mortality within 28 days after birth

    Time frame: within 28 days after birth

Secondary outcomes

  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

07

Study locations

1 site
  • University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM),
    Mahajanga, Madagascar
08

References and documents

Publications

  • 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. PubMed 20121708 ↗
  • 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. PubMed 21635363 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2007, a primary completion of Sep 2008 and a completion of Mar 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2007
First posted
Sep 18, 2007
Start
Aug 2007
Primary completionActual
Sep 2008
CompletionActual
Mar 2009
Last update
Dec 12, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00531492
Lead sponsor
Foundation for Advanced Studies on International Development
Collaborators
St.Luke's Life Science Institute, Tokyo, Japan
Responsible party
Shuko Nagai (Groupe d'Etude de la Technique Kangourouà, Foundation for Advanced Studies on International Development) — Principal investigator
First posted
Sep 18, 2007
Start date
Aug 2007
Primary completion
Sep 2008
Completion
Mar 2009
Last update
Dec 12, 2011

Study contacts

Shuko Nagai, MD
principal investigator · Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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