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Newborn Care Kit to Save Lives in GB, Pakistan

NCT04798833 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27448

Last updated 2025-06-06

No results posted yet for this study

Summary

Neonatal deaths account for almost half of all deaths in children under 5 years of age. Pakistan has the world's highest neonatal mortality rate (NMR), and many of these deaths are preventable. In this study, the investigators propose the use of an evidence-based, integrated newborn care kit (iNCK) to promote safer delivery, provide early identification of danger signs, improve newborn health, and reduce NMR. The investigators hypothesize that use of the iNCK will result in at least a 25% reduction in NMR among participants who receive the iNCK compared with participants who do not receive the iNCK.

Conditions

  • Neonatal Mortality
  • Omphalitis
  • Post-Partum Hemorrhage

Interventions

DEVICE

Integrated Newborn Care Kit (iNCK)

Contents of the integrated newborn care kit: * Clean birth kit: sterile blade, clean plastic sheet, plastic gloves, hand soap, cord ties/clamp, maternity pad to absorb post-natal bleeding, 10 cotton balls for applying Chlorhexidine (CHX) to the umbilical stump. * 3x200 µg dissolvable tablets of misoprostol to be ingested prophylactically following delivery of the baby and before delivery of the placenta to prevent post-partum hemorrhage * 4% CHX solution (15 mL) * Sunflower oil emollient (50 mL) * Temperature monitoring strip or sticker * Fleece blanket for the newborn * Click to heat warmer * Pictorial guide that illustrates how and when to use each kit component * Handheld electronic scale with suspended cloth sling (the scale will not be included with the kit but rather one will be issued to each Lady Health Worker in the experimental arm) Other Names: Neonatal Care Kit

Sponsors & Collaborators

  • The Aga Khan Foundation

    collaborator OTHER

  • Aga Khan Health Services

    collaborator OTHER

  • Aga Khan University

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Shaun Morris, MD, MPH · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-09-30
Completion
2025-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04798833 on ClinicalTrials.gov