None listed
Conditions
Interventions
Intervention1: immediate KMC: iKMC (continuous skin-to-skin contact/ kangaroo mother care initiated immediately after birth with mother or surrogate)
Control Intervention1: KMC after stabilisation: KM
Sponsors
World Health Organization
Eligibility
Inclusion criteria
Inclusion criteria: All babies born alive in the participating hospitals, with birth weight between 1.0 to less then 1.8 kg, enrolled in parent study & survive the first 28 days of life 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.
Exclusion criteria
Exclusion criteria: 1.Exclusion criteria (parent study) (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. 2. Exclusion criteria (current study) (i) The mother or guardian is unwilling to provide the consent. (ii)The mother infant duo are unwilling to come for follow-up visits. (iii)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I. Developmental delay II. Cerebral palsy III. Hearing impairment IV. Vision impairment V. EpilepsyTimepoint: I. Between 24 to 30 month chronological age. II. 6,12 and 24 month III. before 3 Month IV. 12 month V. 3,6,9,12,15,18,21,24 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Feeding practicesTimepoint: 3,6,9,12,15,18,21,24 month;GrowthTimepoint: at 6,12 and 24 months of age;Home environmentTimepoint: 18 months;Maternal depressionTimepoint: 6 and 12 months of age;MortalityTimepoint: between 3 months of age and 2 years of age | — |
Countries
Ghana, India, Malawi, Nigeria, Tanzania
Contacts
Public ContactDr Nitya Wadhwa
Vardhman Mahavir Medical College & Safdarjung Hospital
Outcome results
None listed