Neonatal Package Study in Rural District of Pakistan

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02279381

Enrollment

1450

Registered

2014-10-31

Start date

2014-11-30

Completion date

2015-11-30

Last updated

2016-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Infections

Keywords

Chlorhexidine, Kangaroo mother care, RCT

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.

Interventions

DRUGChlorhexidine

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

OTHERKangaroo Mother Care

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

OTHEREssential 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

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.

Design outcomes

Primary

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

Secondary

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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026