Long term neurodevelopment in low-birth-weight babies who received Kangaroo Mother Care (KMC) compared to those who did not: A follow-up study from community initiated KMC Trial

We did a trial to assess the effect of community-initiated kangaroo mother care (ciKMC) provided to low birth weight (LBW) babies weighing 1500–2250 g on neonatal and infant survival in the first 6 months of life (CTRI/2016/01/006524). Mothers and infants in the intervention group were visited by study team at home (days 1–3, 5, 7, 10, 14, 21, and 28) to support kangaroo mother care (i.e., skin-to-skin contact and exclusive breastfeeding). The control group received routine care.

The present study is a follow-up study of LBW infants enrolled in the primary trial. The aim of this follow-up study is to assess the effect of community-initiated Kangaroo Mother Care (ciKMC) compared to routine care during neonatal period on neurodevelopment at 6-7 years of child age. Children enrolled in the main trial will be contacted when they are 6-7 years of age and if consent is available from their parents/caregiver(s), neurodevelopment assessments will be conducted by the trained psychologists. The assessments among the enrolled children will be done by using the following tools: Wechsler Intelligence scale for children (WISC-IVINDIA), neuropsychological test battery (NEPSY-II), Behavior rating inventory of executive function (BRIEF-2), and Annual status of education report (ASER). Eye tracking assessments will be conducted in a sub-sample of children.

The duration of this study is 5 years. In the first year, study preparatory activities such as obtaining ethical clearance, procurement of psychometric assessment tools, setting up of assessment clinic and recruitment and training of the team was undertaken. Enrolment of the first child will be done after the CTRI registration.