Neonatal Package Study in Rural District of Pakistan

June 8, 2016 updated by: Dr Sajid Bashir Soofi, Aga Khan University

A Randomized Controlled Trial to Evaluate the Acceptability, Feasibility and Efficacy of the Use of a Neonatal Package to Reduce Neonatal Infection in a Rural District of Pakistan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The global neonatal mortality burden is one of the imminent factors which derail the achievement of the MDG 4 in many developing countries including Pakistan. Four million infants infants die in their first 28 days of their lives which account for about 40% of the total under-five mortality. The burden of neonatal mortality in Pakistan is alarming as the current neonatal mortality rate (NMR) is 55 per 1000 live births, third worst in the world. The major causes of these deaths are infections, preterm births and birth asphyxia which are avoidable. Despite many initiatives the NMR remains unchanged since last decade in Pakistan.

Literature shows that low cost facility and community based interventions can reduce NMR significantly. Early neonatal care, application of chlorhexidine for cord care and Kangaroo Mother Care (KMC) have been recognized as effective intervention in reduction of neonatal morbidity and subsequently neonatal mortality in many developing countries. However these interventions have never been tested as a package and data about their combined effect is scarce both in Pakistan and developing countries.

Considering the importance of the issue and well recognized interventions we 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, KMC and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and standard neonatal care alone. We anticipate that this study will provide an evidence base way forward benefiting the children of Pakistan.

Study Type

Interventional

Enrollment (Actual)

1450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Dadu, Sindh, Pakistan
        • Taluka Hospital KN Shah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All healthy newborns born in the study settings will be systematically enrolled in the trial after prior consent.

Exclusion Criteria:

  • Infants with congenital/birth defects,
  • any localized infection on the peri umbilical region at the time of birth or application of
  • any other material such as dung etc before enrollment on the cord.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group A
  1. Essential Neonatal Care
  2. Kangaroo mother Care
  3. Application of 4% Chlorhexidine
  4. Education and counseling for mothers and care providers
Drug: Chlorhexidine
4% chlorhexidine will be applied to the umbilical stump from day 1 to day 10
Other Names:
  • Antiseptic
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
Experimental: Intervention group B
  1. Essential Neonatal Care
  2. Application of 4% Chlorhexidine
  3. Education and counseling for mothers and care providers
Drug: Chlorhexidine
4% chlorhexidine will be applied to the umbilical stump from day 1 to day 10
Other Names:
  • Antiseptic
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
Active Comparator: Control group
  1. Essential Neonatal Care
  2. Education and counseling for mothers and care providers
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.)
Time Frame: 28 days post recruitment
Clinical presence of danger signs as per the IMNCI guidelines.
28 days post recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in the Incidence of omphalitis (Redness and Swelling of umbilical stump/cord (Inflammation))
Time Frame: 28 days post recruitment
Redness and Swelling of umbilical stump/cord (Inflammation):
28 days post recruitment
Failure to thrive (Weight, length and OFC appropriate for age as per WHO guidelines)
Time Frame: 28 days post recruitment
Weight, length and OFC appropriate for age as per WHO guidelines
28 days post recruitment
Utilization of KMC Compliance, Frequency and duration
Time Frame: 28 days post recruitment
Compliance, Frequency and duration - hours/day
28 days post recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

University of Sydney
The International Federation of Red Cross and Red Crescent Societies

Investigators

  • Study Director: Muhammad Atif Habib, MPH, Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

October 30, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3106-Ped-ERC-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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