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Newborn Kit to Save Lives in Pakistan

NCT02130856 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8518

Last updated 2017-04-25

No results posted yet for this study

Summary

There are over 3 million annual neonatal deaths. Approximately 2/3 of neonatal deaths are due to infection, low birth weight (LBW), and prematurity. Low tech but high impact interventions and commodities used in unconventional ways could save hundreds of thousands of newborn lives. We propose an integrated evidence-based toolkit usable by community health workers (CHW) to reduce neonatal deaths. The kit will include: Chlorhexidine to be applied to the umbilical stump, sunflower oil emollient to be applied to the skin, ThermoSpot to identify hypo/hyperthermia, and a Mylar infant sleeve with non-electric warmer.

Conditions

  • Neonatal Mortality

Interventions

DEVICE

Neonatal kit

Contents of the neonatal kit: 1. Clean birth kit: sterile blade, a clean plastic square, plastic gloves, hand soap, and cord ties/clamp. 2. 4% Chlorhexidine (CHX) lotion (15 mL) and a bag of cotton balls. 3. Sunflower oil emollient (50 mL) 4. ThermoSpot 5. Mylar infant sleeve 6. Click to heat warmer (http://www.heatinaclick.ca/products/pocket\_size.html) in a fitted cloth pouch. 7. Handheld electric 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.

Sponsors & Collaborators

  • Grand Challenges Canada

    collaborator OTHER

  • UBS Optimus Foundation

    collaborator OTHER

  • Mother and Child Care Trust (MCCT), Pakistan

    collaborator UNKNOWN

  • Aga Khan University

    collaborator OTHER

  • March of Dimes

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

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

  • Zulfiqar A. Bhutta, PhD, MBBS · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-02-26
Completion
2017-02-26

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 NCT02130856 on ClinicalTrials.gov