The follow-up study to evaluate the impact of continuous KMC initiated immediately after birthcompared to KMC initiated after stabilization in newborns with birth weight 1.0 to less then 1.8 kg on their neurodevelopmental outcomes in low-resource settings.

World Health Organization0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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
•(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
•(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.

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