An integrated newborn care kit (iNCK) to save newborn lives and improve health outcomes in Gilgit Baltistan (GB), Pakistan: study protocol for a cluster randomized controlled trial

Sarah M.Abu Fadaleh, Lisa G. Pell, Muhammad Yasin, Daniel S. Farrar, Sher Hafiz Khan, Zachary Tanner, Shariq Paracha, Falak Madhani, Diego G. Bassani, Imran Ahmed, Sajid B. Soofi, Monica Taljaard, Rachel F. Spitzer, Zulfiqar A. Bhutta, Shaun K. Morris

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Ongoing high neonatal mortality rates (NMRs) represent a global challenge. In 2021, of the 5 million deaths reported worldwide for children under five years of age, 47% were newborns. Pakistan has one of the five highest national NMRs in the world, with an estimated 39 neonatal deaths per 1,000 live births. Reducing newborn deaths requires sustainable, evidence-based, and cost-effective interventions that can be integrated within existing community healthcare infrastructure across regions with high NMR. Methods: This pragmatic, community-based, parallel-arm, open-label, cluster randomized controlled trial aims to estimate the effect of Lady Health Workers (LHWs) providing an integrated newborn care kit (iNCK) with educational instructions to pregnant women in their third trimester, compared to the local standard of care in Gilgit-Baltistan, Pakistan, on neonatal mortality and other newborn and maternal health outcomes. The iNCK contains a clean birth kit, 4% chlorhexidine topical gel, sunflower oil emollient, a ThermoSpot™ temperature monitoring sticker, a fleece blanket, a click-to-heat reusable warmer, three 200 μg misoprostol tablets, and a pictorial instruction guide and diary. LHWs are also provided with a handheld scale to weigh the newborn. The primary study outcome is neonatal mortality, defined as a newborn death in the first 28 days of life. Discussion: This study will generate policy-relevant knowledge on the effectiveness of integrating evidence-based maternal and newborn interventions and delivering them directly to pregnant women via existing community health infrastructure, for reducing neonatal mortality and morbidity, in a remote, mountainous area with a high NMR. Trial registration: NCT04798833, March 15, 2021.

Original languageEnglish
Article number2480
JournalBMC Public Health
Volume23
Issue number1
DOIs
Publication statusPublished - Dec 2023

Keywords

  • Cluster randomized trial
  • Gilgit-Baltistan
  • Hypothermia
  • Neonatal mortality
  • Newborn
  • Omphalitis
  • Pakistan
  • Sepsis

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