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Completed

NCT Number: NCT02279381

Neonatal Package Study in Rural District of Pakistan

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.

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Key information

Conditions

Neonatal Infections

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taluka Hospital KN Shah

Dadu, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chlorhexidine

Drug

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

Other names: Antiseptic

Kangaroo mother care

Other

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

Other

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

Primary outcomes

  1. Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.)

    Time frame: 28 days post recruitment

    Clinical presence of danger signs as per the IMNCI guidelines.

Secondary outcomes

  1. Reduction in the Incidence of omphalitis (Redness and Swelling of umbilical stump/cord (Inflammation))

    Time frame: 28 days post recruitment

    Redness and Swelling of umbilical stump/cord (Inflammation):

  2. Failure to thrive (Weight, length and OFC appropriate for age as per WHO guidelines)

    Time frame: 28 days post recruitment

    Weight, length and OFC appropriate for age as per WHO guidelines

  3. Utilization of KMC Compliance, Frequency and duration

    Time frame: 28 days post recruitment

    Compliance, Frequency and duration - hours/day

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • The International Federation of Red Cross and Red Crescent Societies
  • University of Sydney

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 31, 2014
Registry last updated
Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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