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Neonatal Package Study in Rural District of Pakistan

NCT02279381 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1450

Last updated 2016-06-09

No results posted yet for this study

Summary

Neonatal mortality has been a notable health issue in Pakistan. Considering the importance of the issue and well recognized interventions the investigators are proposing a randomized controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, Kangaroo Mother Care (KMC) and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and essential neonatal care alone. The investigators anticipate that this study will provide an evidence base way forward benefiting the children of Pakistan.

Conditions

  • Neonatal Infections

Interventions

DRUG

Chlorhexidine

4% chlorhexidine will be applied to the umbilical stump from day 1 to day 10

OTHER

Kangaroo Mother Care

Skin to Skin Care which is Kangaroo mother care will be carried out by mother from Day 1 till the study completion

OTHER

Essential Neonatal Care

Essential Neonatal Care ensures delayed bathing, use of colostrum, exclusive breast feeding, skin to skin care for hypothermia, dry cord care, eye care and immunization for the newborn

Sponsors & Collaborators

  • University of Sydney

    collaborator OTHER

  • The International Federation of Red Cross and Red Crescent Societies

    collaborator OTHER

  • Aga Khan University

    lead OTHER

Principal Investigators

  • Muhammad Atif Habib, MPH · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-11-30
Completion
2015-11-30

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 NCT02279381 on ClinicalTrials.gov