JMIR Publications

ABSTRACT

Background:

Neonatal mortality, due to preterm birth and low birthweight, remains a major challenge for Pakistan. Kangaroo mother care is a unique, low-cost intervention proven to reduce neonatal mortality and morbidity and increase exclusive breastfeeding rates. Kangaroo mother care has not been tried in community settings in Pakistan. We aim to implement and evaluate the effectiveness of community-based kangaroo mother care package to reduce neonatal morbidity and mortality among preterm/low birthweight infants. This will provide evidence for policy development and large-scale implementation of KMC across the country to reduce neonatal.

Objective:

The primary objective of this trial is to reduce neonatal mortality among preterm/low birthweight infants. The secondary objectives are growth measured as weight gain, reduction in incidence of possible serious bacterial infection (PSBI), increased exclusive breastfeeding and continued breastfeeding practices.

Methods:

We designed a community-based cluster randomized controlled trial in one rural district of Pakistan. Stable, low birth weight babies ≥1200-<2500 grams are included in the study. Kangaroo mother care package consisting of KMC kit, information and counseling material and community mobilization through KMC champion (village volunteers) is design after formative research in same geography is implement in intervention clusters. The standard essential newborn care offered in the control clusters. Infants would be recruited and followed up by independent teams of data collectors. Data is collected on the duration of skin-to-skin contact, growth, breastfeeding practices, morbidities, neonatal mortality and neurodevelopment status. Data analysis will be by intention to treat principle. The cox regression model will be used for the primary outcome of neonatal mortality. The secondary outcomes will be assessed using linear or logistic regression.

Results:

The study protocol was approved by the Ethics Review Committee of Aga Khan University, Pakistan in February 2017. Data collection began in August 2019 and will be completed in December 2021. Data analyses are yet to be completed.

Conclusions:

This intervention, if effective, has the “potential to be translated into a safe, effective, affordable, and widely utilized intervention” to prevent sepsis and subsequently improve survival in LBW neonates in Pakistan, and other low-and middle-income countries. Clinical Trial: Clinicaltrials.gov: NCT03545204