Neonatal Package Study in Rural District of Pakistan

Neonatal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279381
• Other study ID #: 3106-Ped-ERC-14
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2014
• Last updated: June 8, 2016
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1450
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neonatal Infections

Intervention

Drug:
• Chlorhexidine
4% chlorhexidine will be applied to the umbilical stump from day 1 to day 10

Other:
• 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
• 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

Locations

Country	Name	City	State
Pakistan	Taluka Hospital KN Shah	Dadu	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	The International Federation of Red Cross and Red Crescent Societies, University of Sydney

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.)	Clinical presence of danger signs as per the IMNCI guidelines.	28 days post recruitment	Yes
Secondary	Reduction in the Incidence of omphalitis (Redness and Swelling of umbilical stump/cord (Inflammation))	Redness and Swelling of umbilical stump/cord (Inflammation):	28 days post recruitment	Yes
Secondary	Failure to thrive (Weight, length and OFC appropriate for age as per WHO guidelines)	Weight, length and OFC appropriate for age as per WHO guidelines	28 days post recruitment	Yes
Secondary	Utilization of KMC Compliance, Frequency and duration	Compliance, Frequency and duration - hours/day	28 days post recruitment	Yes