Immediate skin to skin contact of the baby with mother or the surrogate
- Conditions
- Health Condition 1: P00- Newborn affected by maternal conditions that may be unrelated to present pregnancy
- Registration Number
- CTRI/2018/08/015369
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1377
All babies born alive in the participating hospitals, with birth weight between 1.0 to less then 1.8 kg, regardless of their gestational age, are eligible for participation in this trial with their mothers. The mother-baby pair is still eligible if the mode of delivery is caesarean section, if the babies are twins or if the mother experiences some complications during labour and delivery that are expected to resolve within 3 days.
(i) the mother is younger than 15 years of age
(ii) the mother (or her guardian in case mother is a minor aged 15-17 years) is unable or unwilling to provide consent;
(iii) the mother is unlikely to be able to provide KMC for the first 3 days after birth, e.g. she has eclampsia, shock or has undergone major surgery;
(iv) the baby is unable to breathe spontaneously within 1 hour of birth;
(v) multiple pregnancy: triplets or more;
(vi) the baby has a congenital malformation that interferes with the intervention, or the intervention interferes with the required care for the congenital malformation;
(vii) the place of residence is not a part of the defined study area (the study area will be defined to make 28-day follow up home visit feasible)
(viii) If for any reason the mother baby pair cannot be enrolled within 2 hours of birth of the baby.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MortalityTimepoint: (i) mortality between enrolment and 72 hours of age, and <br/ ><br>(ii) mortality between enrolment and 28 days of age. <br/ ><br>
- Secondary Outcome Measures
Name Time Method time to stabilization, hypothermia and risk of infection during hospital stay, time to hospital discharge, exclusive breastfeeding at the end of neonatal period, maternal satisfaction with care received in the hospital, and maternal depression,Time to being fully breastfed, suspected sepsis (Early onset: less than 72 hours of age, Late onset more than 72 hours of age), Probable sepsis, early or late onset, Hypoglycemia, Death in babies not enrolled in the study up to 72 hours of age.Timepoint: None