Neonatal Package Study in Rural District of Pakistan

NCT02279381 | Completed Phase 4 DMC

• 1 other identifier: 3106-Ped-ERC-14
• Study Type: interventional
• Target: 1,450
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Infections

Keywords

Chlorhexidine; Kangaroo mother care; RCT

Outcome Measures

Primary Outcomes (1)

• Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.)

  Clinical presence of danger signs as per the IMNCI guidelines.

  28 days post recruitment

Secondary Outcomes (3)

• 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

Study Arms (3)

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

Drug: Chlorhexidine; Other: Kangaroo Mother Care; Other: Essential Neonatal Care

Intervention group B

EXPERIMENTAL

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

Drug: Chlorhexidine; Other: Essential Neonatal Care

Control group

ACTIVE COMPARATOR

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

Other: Essential Neonatal Care

Interventions

Chlorhexidine DRUG

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

Also known as: Antiseptic

Intervention group A; Intervention group B

Kangaroo Mother Care OTHER

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

Intervention group A

Essential Neonatal Care OTHER

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

Control group; Intervention group A; Intervention group B

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead
• University of Sydney: collaborator
• The International Federation of Red Cross and Red Crescent Societies: collaborator

Study Sites (1)

Taluka Hospital KN Shah

Dadu, Sindh, Pakistan

Location

MeSH Terms

Interventions

Chlorhexidine; Anti-Infective Agents, Local; Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Muhammad Atif Habib, MPH

  Aga Khan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 31, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

PA (1)