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

Not Applicable

Completed

• Conditions: Low Birth Weight
• Interventions: Behavioral: TK as soon as possible within 24 hours after birth; Other: Conventional care

• Registration Number: NCT00531492
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-17
• Study First Submitted QC: 2007-09-17
• Study First Posted: 2007-09-18
• Primary Completion: 2008-09
• Study Completion: 2009-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-08
• Last Update Posted: 2011-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	TK as soon as possible within 24 hours after birth	-
B	Conventional care	-

Primary Outcome Measures

Name	Time	Method
Mortality within 28 days after birth	within 28 days after birth

Secondary Outcome Measures

Name	Time	Method
Difference of (Baby's) loss in weight within 2 days	within 2 days
Mobility within 6 months or 1 year after birth	within 6 months or 1 year
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) 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
Incidence of hypothermia during hospitalisation and (or) during outpatient department （lower than 35.5℃）	Within 28 days after birth
Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min)	within 28 days after birth
Incidence of apnea during hospitalisation (> 20 sec)	within 28 days after birth
Incidence of desaturation during hospitalisation ( <87%)	within 28 days after birth
Length of hospitalisation	within 28 days after birth
Discharge within 7days after birth	within 7days after birth
Mortality and Morbility within 6 months or 1 year after birth	within 6 months or 1 year
Mortality within 6 months or 1 year after birth	within 6 months or 1 year
Incidence of hyperthermia during hospitalisation and (or) outpatient department （upper than 37.5℃）	Within 28 days after birth

Trial Locations

Locations (1)

University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM),; 🇲🇬 Mahajanga, Madagascar