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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00531492
• Date of registration: 17/09/2007
• Prospective Registration: No
• Primary sponsor: Foundation for Advanced Studies on International Development
• Public title: 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
• Scientific 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
• Date of first enrolment: August 2007
• Target sample size: 73
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00531492
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Madagascar

Contacts

• Name: Shuko Nagai, MD
• Affiliation: Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 24 Hours
Gender: Both

Health Condition(s) or Problem(s) studied

Low Birth Weight

Intervention(s)

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

Other: Conventional care

Primary Outcome(s)

Mortality within 28 days after birth [Time Frame: within 28 days after birth]

Secondary Outcome(s)

Difference of (Baby's) loss in weight within 2 days [Time Frame: within 2 days]

Incidence of desaturation during hospitalisation ( <87%) [Time Frame: within 28 days after birth]

Incidence of hypothermia during hospitalisation and (or) during outpatient department (lower than 35.5?) [Time Frame: Within 28 days after birth]

Incidence of apnea during hospitalisation (> 20 sec) [Time Frame: within 28 days after birth]

Mortality and Mobility within 28 days after birth [Time Frame: within 28 days after birth]

Mortality within 6 months or 1 year after birth [Time Frame: within 6 months or 1 year]

Difference of (Baby's) Body weight of 14th day after birth [Time Frame: 14th day after birth]

Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min) [Time Frame: within 28 days after birth]

Incidence of hyperthermia during hospitalisation and (or) outpatient department (upper than 37.5?) [Time Frame: Within 28 days after birth]

Difference of (Baby's) Body weight of 28th day after birth [Time Frame: 28th day after birth]

Length of hospitalisation [Time Frame: within 28 days after birth]

Discharge within 7days after birth [Time Frame: within 7days after birth]

Mobility within 28 days after birth [Time Frame: within 28 days after birth]

Mobility within 6 months or 1 year after birth [Time Frame: within 6 months or 1 year]

Mortality and Morbility within 6 months or 1 year after birth [Time Frame: within 6 months or 1 year]

Secondary ID(s)

FASID-06-CE-56

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St.Luke's Life Science Institute, Tokyo, Japan