None listed
Conditions
Brief summary
The aim of this trial is to evaluate the efficacy of continuous Kangaroo mother care initiated as soon as after birth for newborns with birth weight from 1.0 to <1.8 kg compared to the current recommendation of initiating continuous KMC only after stabilisation. The hypothesis is that immediate KMC would reduce the mortality in this group of LBW babies in the first 72 hours and in the neonatal period (first 28 days of life). The study is a multi-country, multi-centre, randomized controlled trial. The randomised controlled trial is being conducted in tertiary care hospitals in Ghana, India, Malawi, Nigeria and Tanzania. The intervention has three main components: (i) promotion and support for continuous skin-to-skin contact initiated as soon as possible after birth with a mother or a surrogate, aiming for at least 20 hours per day, which is continued during entire hospital stay. Continuous KMC before stabilization will be provided in the neonatal special care unit, and continuous KMC after stabilization in the KMC ward. (ii) promotion and support for early exclusive breastfeeding during hospital stay, and (iii) provision of health care for mother and baby with as little separation as possible during hospital stay.
Interventions
The intervention is Kangaroo Mother Care (KMC) for low birth weight (LBW) babies >1 kg and < 1.8 kg starting as soon as possible after birth. The intervention has three main components:
(i) promotion and support for continuous skin-to-skin contact initiated as soon as possible after birth with a mother or a surrogate, aiming for at least 20 hours per day, which is continued during entire hospital stay. Continuous KMC before stabilization will be provided in the neonatal special care unit, and c
The intervention is Kangaroo Mother Care (KMC) for low birth weight (LBW) babies >1 kg and < 1.8 kg starting as soon as possible after birth. The intervention has three main components: (i) promotion and support for continuous skin-to-skin contact initiated as soon as possible after birth with a mother or a surrogate, aiming for at least 20 hours per day, which is continued during entire hospital stay. Continuous KMC before stabilization will be provided in the neonatal special care unit, and continuous KMC after stabilization in the KMC ward. (ii) promotion and support for early exclusive breastfeeding during hospital stay, and (iii) provision of health care for mother and baby with as little separation as possible during hospital stay. WHO manual on Kangaroo Mother Care, and specifically desgined training manuals for immediate KMC are used. Face to face counselling on KMC is provided to mothers/surrogates by KMC supporters as long as mother feels they need the counselling. Counselling includes explanation and demonstration of the method of providing skin to skin contact, the importance of KMC to the baby and ways to comfortably provide KMC. The most important factor for successful implementation of the intervention is keeping the mother comfortable. This includes among other things, taking care of her pain, comfortable bed, toilet, food and water, and a soothing environment. Breastfeeding support includes counselling on the importance of early and exclusive breastfeeding, and support for appropriate positioning and attachment. The worker also counsels the mother on how to cope with the fact that she has had a low birth weight baby. Immediate KMC is delivered by the paediatrician/neonatologist, nurses, and KMC support workers. Immediate KMC period is from randomization to stabilization while the baby is in SNCU. Minimum period is 24 hours and extends upto the time baby is shifted out of SNCU. In the intervention group, the mother and baby will remain in skin-to-skin contact from the time of randomization. The mother and baby will be provided health care in KMC position as much as possible. Mothers will be provided health care by obstetric staff while she is in the neonatal unit. If a mother has any complication for which she needs to be transferred to the postnatal ward, intensive care unit or operation theatre, skin-to-skin contact will be continued with a surrogate. If the baby requires a procedure or treatment that is not possible in skin-to-skin contact, the baby will be shifted to a cot or radiant warmer. skin-to-skin contact will be temporarily interrupted for the period of the procedure or treatment, and recommenced as soon as possible after that. If both the mother and surrogate are temporarily not available to provide KMC in the SCNU, the baby will be kept in a cot, incubator or radiant warmer as required. To monitor the compliance with intervention a daily sheet is completed by the KMC support workers in the SCNU and KMC ward. This sheet has an hourly record of duration of skin-to-skin contact with the mother or the surrogate, and the period of separation. This includes the brief KMC sessions that control group babies may receive in the SCNU. The number of times the baby is put to the breast is also recorded. At the home visit on day 29, mothers is asked if KMC was continued after discharge from hospital.
Sponsors
World Health Organization
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
All mothers and their newborn babies born alive in the participating hospitals, with birth weight between 1.0 kg to less then 1.8 kg, regardless of their gestational age.
Exclusion criteria
Among those who meet inclusion criteria, the following will be excluded: (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.
Outcome results
None listed