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

Low Birth Weight Clinical Trial

— EtudeTK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531492
• Other study ID #: FASID-06-CE-56
• Status: Completed
• Phase: N/A
• First received: September 17, 2007
• Last updated: December 8, 2011
• Start date: August 2007
• Est. completion date: March 2009

Study information

• Verified date: December 2011
• Source: Foundation for Advanced Studies on International Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Madagascar: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: March 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Low Birth Weight

Intervention

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

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

Locations

Country	Name	City	State
Madagascar	University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM),	Mahajanga

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Advanced Studies on International Development	St.Luke's Life Science Institute, Tokyo, Japan

Country where clinical trial is conducted

Madagascar, 

References & 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: 10.111 — View 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality within 28 days after birth		within 28 days after birth	Yes
Secondary	Mobility within 28 days after birth		within 28 days after birth	Yes
Secondary	Mortality and Mobility within 28 days after birth		within 28 days after birth	Yes
Secondary	Difference of (Baby's) loss in weight within 2 days		within 2 days	Yes
Secondary	Difference of (Baby's) Body weight of 14th day after birth		14th day after birth	Yes
Secondary	Difference of (Baby's) Body weight of 28th day after birth		28th day after birth	Yes
Secondary	Incidence of hypothermia during hospitalisation and (or) during outpatient department (lower than 35.5?)		Within 28 days after birth	Yes
Secondary	Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min)		within 28 days after birth	Yes
Secondary	Incidence of apnea during hospitalisation (> 20 sec)		within 28 days after birth	Yes
Secondary	Incidence of desaturation during hospitalisation ( <87%)		within 28 days after birth	Yes
Secondary	Length of hospitalisation		within 28 days after birth	No
Secondary	Discharge within 7days after birth		within 7days after birth	No
Secondary	Mobility within 6 months or 1 year after birth		within 6 months or 1 year	Yes
Secondary	Mortality and Morbility within 6 months or 1 year after birth		within 6 months or 1 year	Yes
Secondary	Mortality within 6 months or 1 year after birth		within 6 months or 1 year	Yes
Secondary	Incidence of hyperthermia during hospitalisation and (or) outpatient department (upper than 37.5?)		Within 28 days after birth	Yes