Risk-differentiated home-based care to reduce infant mortality: an individually randomized trial

The declines in infant and under-5 child mortality rates in India have slowed. Further improvements will require focused approaches for particularly vulnerable children. Recent analyses demonstrate that infants and young children at the highest risk of mortality can be identified by combinations of four child-level characteristics: age less than 2 years; weight-for-age z score less than 3 SD; low birth weight (or preterm birth); and non-initiation of breastfeeding. The findings point to programmatic opportunities to identify vulnerable infants and to deliver care strategies commensurate with their mortality risk. This individual randomized controlled study will evaluate the efficacy of an approach to reduce all-cause mortality in the first 6 months of life, providing home-based care to newborns according to their mortality risk. Infants’ risk status will initially be assessed at enrollment and categorized as Low, Moderate, or High; Low risk (Healthy/Well): Gestational age greater than or equal to 37 weeks, birth weight greater than or equal to 2500 g, absence of signs of possible serious bacterial infection (PSBI), no illness or only transient conditions such as short phototherapy for jaundice or transient tachypnoea not requiring oxygen, no major congenital malformations, established breastfeeding, and healthy mother; Moderate risk: Infants born at 35 to less than 37 weeks or with birth weight 1800 to 2499 g; nursery stay 48 to 72h; respiratory distress or jaundice requiring support or phototherapy greater than 48h; local infection managed with oral antibiotics; minor congenital anomalies interfering with feeding; failure to establish breastfeeding by 72h; maternal illness resolving within 48 to 72h before discharge; High risk: Infants born less than 35 weeks or with birth weight less than 1800 g; nursery stay greater than 72h; history of lethargy, convulsions, refusal to feed, fever, hypothermia, severe jaundice needing exchange transfusion, respiratory distress requiring oxygen for greater than 48h, suspected neurological problem; or maternal mortality/complicated postnatal course (severe bleeding, sepsis, severe anemia, seizures, unconsciousness, or major depressive symptoms). Infants may later transition to higher risk groups if they develop severe illnesses or growth faltering. However, they cannot move to a lower risk category. The frequency of home visits will be adjusted according to the mortality risk. This approach will strengthen the existing Home-Based Newborn Care and Home-Based Young Childcare strategies and extend support for high-risk infants. The study will generate evidence on the efficacy and feasibility of a risk-differentiated home-based care strategy for improving infant survival, providing evidence for scalable interventions and policies in India.