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Table 2 Lessons Emerging from Formative Research for the Randomized Controlled Trial

From: Kangaroo mother care: using formative research to design an acceptable community intervention

Issues

Role of formative Research in Shaping Intervention Package for the RCT

How long to practice KMC and for how many days

Scientific guidance on optimal duration of practicing KMC per day (in hours) and the total duration (in days) was lacking. We advised mothers to give KMC, preferably for 24 h in a day and continue giving till 28 days of infant age or till the baby wriggles out (whichever was earlier). Both these suggestions emerged feasible and acceptable in the formative research. These findings served as an input in the main RCT

Position of mother in SSC

Supine and semi-reclining positions were most comfortable and preferred. The same were advised in the main trial

Use of Binders

Women were not comfortable or confident moving around or doing household chores, with baby in SSC supported by binders, feared that baby will fall. Binders therefore, were decided to be provided to only those who ask for them

Use of Diapers

Diapers were considered unhygienic and thought to cause skin rash. Also, it was believed that they increase the gap between baby’s legs leading to deformity. Therefore, it was planned to offer only to those who asked for.

Personnel to deliver the intervention

SSC initiation and support for initial few days required skilled counselling, effective demonstration, persistent encouragement, empathy and problem solving ability to bring about behaviour change activation. ANM like workers, with higher education and skills were considered appropriate for initiation; ASHAs were able to support mothers during follow up visits

Frequency of visit

Frequent visits needed initially, could be reduced later. Substantial support and encouragement needed during first 3 to 4 days. Less frequent visits needed subsequently once the mother was comfortable doing KMC.

Weight cut off for enrolment

Babies with birth weight ≥ 1500 to ≤2250 g were planned to be included in the study, as babies weighing > 2250 g did not stay in SSC for more than 4 to 5 days (wriggled out earlier) and those weighing < 1500 g required hospital care.

Age cut off for enrolment

Very early enrolment would not be feasible for facility births. A window period of 72 h of birth was considered feasible to initiate KMC at home

Involvement of male members in providing KMC to the baby

Male family members participated enthusiastically in providing SSC; they were planned to be involved from the outset in the RCT