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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Low Birth Weight

Intervention / Treatment
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* Behavioral: TK as soon as possible within 24 hours after birth
* Other: Conventional care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality within 28 days after birth |  | within 28 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)