CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8,518 enrolled
Drug / intervention
Neonatal kitdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02130856
NCT02130856Phase 3Completed
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An Integrated Toolkit to Save Newborn Lives in Pakistan

The Hospital for Sick Children·interventional·Posted May 5, 2014·Updated Apr 25, 2017

In Brief

A Phase 3 clinical trial evaluating Neonatal kit for Neonatal Mortality. Completed, enrolled 8,518 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Mortality
CountriesPakistan
CollaboratorsGrand Challenges Canada, UBS Optimus Foundation, Mother and Child Care Trust (MCCT), Pakistan, Aga Khan University, March of Dimes

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 5, 2014
Enrollment StartApr 1, 2014
Primary CompletionFeb 26, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.2 years ago

Interventions

Neonatal kitdevice

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.