Neonatal Package Study in Rural District of Pakistan

Aga Khan University

Status and phase: Completed; Phase 4

Conditions: Neonatal Infections

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02279381

3106-Ped-ERC-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,450 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,450 participants in 3 patient groups

Intervention group A

Experimental group

Description:

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

Treatment:

Drug: Chlorhexidine

Other: Essential Neonatal Care

Other: Kangaroo Mother Care

Intervention group B

Experimental group

Description:

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

Treatment:

Drug: Chlorhexidine

Other: Essential Neonatal Care

Control group

Active Comparator group

Description:

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

Treatment:

Other: Essential Neonatal Care