Low Birth Weight
Conditions
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)
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.
Interventions
BEHAVIORALTK as soon as possible within 24 hours after birth
Start TK as soon as possible within 24 hours after birth
OTHERConventional care
Start conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)
Sponsors
St.Luke's Life Science Institute, Tokyo, Japan
Foundation for Advanced Studies on International Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality within 28 days after birth | within 28 days after birth |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of apnea during hospitalisation (> 20 sec) | 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 |
| Mobility within 28 days after birth | within 28 days after birth |
Countries
Madagascar
Outcome results
None listed