Clinical trial NCT02279381: Neonatal Package Study in Rural District of Pakistan
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neonatal Infections
Keywords: Chlorhexidine
Kangaroo mother care
RCT
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: University of Sydney
name: The International Federation of Red Cross and Red Crescent Societies
First posted: 2014-10-31
Enrollment: 1450
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.)
timeFrame: 28 days post recruitment
Secondary outcomes:
measure: Reduction in the Incidence of omphalitis (Redness and Swelling of umbilical stump/cord (Inflammation))
timeFrame: 28 days post recruitment
measure: Failure to thrive (Weight, length and OFC appropriate for age as per WHO guidelines)
timeFrame: 28 days post recruitment
measure: Utilization of KMC Compliance, Frequency and duration
timeFrame: 28 days post recruitment
Other outcomes:
Locations:
city: Dadu
country: Pakistan
facility: Taluka Hospital KN Shah
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Muhammad Atif Habib, MPH
role: STUDY_DIRECTOR
References: