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Clinical Trials/NCT02279381
NCT02279381CompletedPhase 4

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

Aga Khan University1 site in 1 country1,450 target enrollmentStarted: November 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
1,450
Locations
1
Primary Endpoint
Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.)

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
1 Day to 28 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Intervention group A

Experimental
  1. Essential Neonatal Care
  2. Kangaroo mother Care
  3. Application of 4% Chlorhexidine
  4. Education and counseling for mothers and care providers

Intervention: Chlorhexidine (Drug)

Intervention group A

Experimental
  1. Essential Neonatal Care
  2. Kangaroo mother Care
  3. Application of 4% Chlorhexidine
  4. Education and counseling for mothers and care providers

Intervention: Kangaroo Mother Care (Other)

Intervention group A

Experimental
  1. Essential Neonatal Care
  2. Kangaroo mother Care
  3. Application of 4% Chlorhexidine
  4. Education and counseling for mothers and care providers

Intervention: Essential Neonatal Care (Other)

Intervention group B

Experimental
  1. Essential Neonatal Care
  2. Application of 4% Chlorhexidine
  3. Education and counseling for mothers and care providers

Intervention: Chlorhexidine (Drug)

Intervention group B

Experimental
  1. Essential Neonatal Care
  2. Application of 4% Chlorhexidine
  3. Education and counseling for mothers and care providers

Intervention: Essential Neonatal Care (Other)

Control group

Active Comparator
  1. Essential Neonatal Care
  2. Education and counseling for mothers and care providers

Intervention: Essential Neonatal Care (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Reduction in the Incidence of omphalitis (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)(28 days post recruitment)
  • Utilization of KMC Compliance, Frequency and duration(28 days post recruitment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Sajid Bashir Soofi

Associate Professor

Aga Khan University

Study Sites (1)

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