Neonatal Package Study in Rural District of Pakistan

NCT ID: NCT02279381

Last Updated: 2016-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-11-30

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.

Conditions

Neonatal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group B

1. Essential Neonatal Care

2. Application of 4% Chlorhexidine

3. Education and counseling for mothers and care providers

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: DRUG

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

Essential Neonatal Care

Intervention Type: 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

1. Essential Neonatal Care

2. Education and counseling for mothers and care providers

Group Type: ACTIVE_COMPARATOR

Essential Neonatal Care

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: DRUG

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

Kangaroo Mother Care

Intervention Type: OTHER

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

Essential Neonatal Care

Intervention Type: 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

Interventions

Chlorhexidine

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

Intervention Type: DRUG

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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Antiseptic

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sydney

OTHER

Sponsor Role: collaborator

The International Federation of Red Cross and Red Crescent Societies

OTHER

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Dr Sajid Bashir Soofi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Atif Habib, MPH

Role: STUDY_DIRECTOR

Aga Khan University

Locations

Taluka Hospital KN Shah

Dadu, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

3106-Ped-ERC-14

Identifier Type: -

Identifier Source: org_study_id