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 adopted after formative research consisting of KMC kit, information and counseling material, and community mobilization using KMC champions (volunteers) is implemented in the 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, the incidence of possible serious bacterial infection, neonatal mortality and impact on neurodevelopment.
RESULTS
The study protocol was approved by the Ethics Review Committee of Aga Khan University, Pakistan on February 2017. Data collection began in August 2019 and will be completed in December 2021. Data analyses are yet to be completed. Data analysis will be by intention to treat principle. The cox regression model will be used for the primary outcome of neonatal mortality, to calculate hazard ratios. The secondary outcomes will be assessed using linear or logistic regression. We expect the results to be published in peer-reviewed journals presentations at relevant conferences by autumn of 2022.
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.
CLINICALTRIAL
Clinicaltrials.gov: NCT03545204
Effect of community-based kangaroo mother care package on neonatal mortality among preterm and low birthweight infants in rural Pakistan: Protocol for a cluster randomized controlled trial (Preprint)
