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Neonatal Package Study in Rural District of Pakistan

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ClinicalTrials.gov Identifier: NCT02279381
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : June 9, 2016
Sponsor:
Collaborators:
University of Sydney
The International Federation of Red Cross and Red Crescent Societies
Information provided by (Responsible Party):
Dr Sajid Bashir Soofi, 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.

Condition or disease Intervention/treatment Phase
Neonatal Infections Drug: Chlorhexidine Other: Kangaroo Mother Care Other: Essential Neonatal Care Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : November 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015


Arm Intervention/treatment
Experimental: Intervention group A
  1. Essential Neonatal Care
  2. Kangaroo mother Care
  3. Application of 4% Chlorhexidine
  4. Education and counseling for mothers and care providers
Drug: Chlorhexidine
4% chlorhexidine will be applied to the umbilical stump from day 1 to day 10
Other Name: Antiseptic

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

Other: 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

Experimental: Intervention group B
  1. Essential Neonatal Care
  2. Application of 4% Chlorhexidine
  3. Education and counseling for mothers and care providers
Drug: Chlorhexidine
4% chlorhexidine will be applied to the umbilical stump from day 1 to day 10
Other Name: Antiseptic

Other: 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

Active Comparator: Control group
  1. Essential Neonatal Care
  2. Education and counseling for mothers and care providers
Other: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279381


Locations
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Pakistan
Taluka Hospital KN Shah
Dadu, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
University of Sydney
The International Federation of Red Cross and Red Crescent Societies
Investigators
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Study Director: Muhammad Atif Habib, MPH Aga Khan University
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Responsible Party: Dr Sajid Bashir Soofi, Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT02279381    
Other Study ID Numbers: 3106-Ped-ERC-14
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Keywords provided by Dr Sajid Bashir Soofi, Aga Khan University:
Chlorhexidine
Kangaroo mother care
RCT
Additional relevant MeSH terms:
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Infection
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants