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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Birth Weight
• Intervention / Treatment: Behavioral: TK as soon as possible within 24 hours after birth; Other: Conventional care

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Other: Conventional care; Start conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)
Experimental: A	Behavioral: TK as soon as possible within 24 hours after birth; Start TK as soon as possible within 24 hours after birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality within 28 days after birth	within 28 days after birth

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
Mobility within 6 months or 1 year after birth	within 6 months or 1 year
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

Collaborators and Investigators

• Sponsor: Foundation for Advanced Studies on International Development
• Collaborators: St.Luke's Life Science Institute, Tokyo, Japan
• Investigators: Principal Investigator: Shuko Nagai, MD, Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: September 17, 2007
• First Submitted That Met QC Criteria: September 17, 2007
• First Posted (Estimate): September 18, 2007

Study Record Updates

• Last Update Posted (Estimate): December 12, 2011
• Last Update Submitted That Met QC Criteria: December 8, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• 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)
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: FASID-06-CE-56