Clinical trial NCT00531492: Efficacy of Continuous Skin to Skin Care (Technique Kangaroo: TK) After Birth for Low Birth Weight (LBW) Infants and Their Mothers in Developing Countries
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Birth Weight
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)
Lead sponsor: Foundation for Advanced Studies on International Development
Sponsor class: OTHER
Collaborators: name: St.Luke's Life Science Institute, Tokyo, Japan
First posted: 2007-09-18
Enrollment: 73
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mortality within 28 days after birth
timeFrame: within 28 days after birth
Secondary outcomes:
measure: Mobility within 28 days after birth
timeFrame: within 28 days after birth
measure: Mortality and Mobility within 28 days after birth
timeFrame: within 28 days after birth
measure: Difference of (Baby's) loss in weight within 2 days
timeFrame: within 2 days
measure: Difference of (Baby's) Body weight of 14th day after birth
timeFrame: 14th day after birth
measure: Difference of (Baby's) Body weight of 28th day after birth
timeFrame: 28th day after birth
measure: Incidence of hypothermia during hospitalisation and (or) during outpatient department （lower than 35.5℃）
timeFrame: Within 28 days after birth
measure: Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min)
timeFrame: within 28 days after birth
measure: Incidence of apnea during hospitalisation (> 20 sec)
timeFrame: within 28 days after birth
measure: Incidence of desaturation during hospitalisation ( <87%)
timeFrame: within 28 days after birth
measure: Length of hospitalisation
timeFrame: within 28 days after birth
measure: Discharge within 7days after birth
timeFrame: within 7days after birth
measure: Mobility within 6 months or 1 year after birth
timeFrame: within 6 months or 1 year
measure: Mortality and Morbility within 6 months or 1 year after birth
timeFrame: within 6 months or 1 year
measure: Mortality within 6 months or 1 year after birth
timeFrame: within 6 months or 1 year
measure: Incidence of hyperthermia during hospitalisation and (or) outpatient department （upper than 37.5℃）
timeFrame: Within 28 days after birth
Other outcomes:
Locations:
city: Mahajanga
country: Madagascar
facility: University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM),
Study officials:
affiliation: Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar
name: Shuko Nagai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.