Neonatal Package Study in Rural District of Pakistan
- Conditions
- Neonatal Infections
- Interventions
- Registration Number
- NCT02279381
- Lead Sponsor
- Aga Khan University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1450
- All healthy newborns born in the study settings will be systematically enrolled in the trial after prior consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group A Chlorhexidine 1. Essential Neonatal Care 2. Kangaroo mother Care 3. Application of 4% Chlorhexidine 4. Education and counseling for mothers and care providers Intervention group A Kangaroo Mother Care 1. Essential Neonatal Care 2. Kangaroo mother Care 3. Application of 4% Chlorhexidine 4. Education and counseling for mothers and care providers Intervention group A Essential Neonatal Care 1. Essential Neonatal Care 2. Kangaroo mother Care 3. Application of 4% Chlorhexidine 4. Education and counseling for mothers and care providers Intervention group B Chlorhexidine 1. Essential Neonatal Care 2. Application of 4% Chlorhexidine 3. Education and counseling for mothers and care providers Intervention group B Essential Neonatal Care 1. Essential Neonatal Care 2. Application of 4% Chlorhexidine 3. Education and counseling for mothers and care providers Control group Essential Neonatal Care 1. Essential Neonatal Care 2. Education and counseling for mothers and care providers
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Taluka Hospital KN Shah
🇵🇰Dadu, Sindh, Pakistan