Birth Cohort in Rahimyar Khan, Pakistan

April 24, 2017 updated by: Shaun Morris, The Hospital for Sick Children

A Longitudinal Birth Cohort Study in Rahimyar Khan, Pakistan

In 2010, 7.6 million children under the age of five died worldwide and yet the causes of only 2.7% (0.205 million) of these deaths were medically certified. A thorough understanding of the causes of child mortality is necessary to guide research efforts aimed at tackling this important global health problem. Prospective birth cohort studies present an opportunity to examine the relationships between early-life exposures and multiple health and non-health related outcomes including death, illness, and socioeconomic factors. In this study, we will provide insight into the underlying causes of child mortality by collecting high-quality data on early-life exposures and health and non-health related outcomes in the first year of life.

Study Overview

Status

Completed

Conditions

Detailed Description

In 2010, 7.6 million children under the age of five died worldwide (Liu et al., 2012). Notably, the burden of under-five mortality varies dramatically by country. The majority of total child deaths in 2010 were seen in Africa (3.6 million) and southeast Asia (2.1 million deaths), compared to 0.16 million and 0.28 million under-five deaths in Europe and the Americas, respectively (Liu et al., 2012). Strikingly, nearly half of the world's under-five child deaths in 2010 could be attributed to only five countries: India, Nigeria, Democratic Republic of the Congo, Pakistan, and China (Liu et al., 2012). In Pakistan alone, over 420,000 under-five child deaths occurred in 2010 (Liu et al., 2012).

A thorough understanding of the etiology of child mortality is necessary to guide research efforts aimed at tackling this important global health problem. Importantly, in 2010, the causes of only 2.7% (0.205 million) of all deaths in children under the age of five were medically certified (Liu et al., 2012), highlighting the need to gather high-quality data on the causes of mortality.

Prospective longitudinal birth cohort studies present an opportunity to examine temporal relationships between early-life exposures (i.e. prenatal, pregnancy, and early postnatal exposures) and multiple health and non-health related outcomes including mortality, morbidity, and socioeconomic position. It is well documented that exposures that occur early in life, including genetic, environmental, socioeconomic, and lifestyle factors, may have long-lasting effects on growth, development, and health outcomes throughout an individual's entire life course (Lynch & Smith, 2005). Thus, data on exposures during pregnancy and early childhood are valuable and may provide clues to the etiology of long-term outcomes.

Additional value can be gained through cross-cohort collaborations and comparisons (Larsen et al., 2013)(Paternoster et al., 2012)(Brion et al., 2011). By pooling data from multiple cohort studies, causal inferences can be made with greater confidence. In addition, through cross-country comparisons, heterogeneity in exposures is often increased making it more likely that an association between exposure and outcome will be observed. Similarly, cross-cohort comparisons enable researchers to investigate patterns associated with health, social, and economic outcomes in distinct regions of the world. These types of analyses may provide valuable insight into the underlying causes of global health inequalities.

The objective of this study is to implement a longitudinal prospective birth cohort study in Pakistan to obtain extensive and high-quality information on early-life exposures and health and non-health related outcomes in the first year of life. Concurrent to the design and implementation of this cohort study in Pakistan, similar studies are being implemented in Kenya (Coastal Region Cohort, Lead PI: Dr. Shaun Morris), Brazil (Pelotas Cohort, Lead PIs: Dr. Pedro R.C. Hallal, Dr. Diego G. Bassani and Dr. Mariangela Silveira), and South Africa (Birth to Twenty Cohort, Lead PI: Dr. Shane Norris). The investigators of each project have communicated their intent to align study materials in an effort to increase the ease of future comparisons between findings. This study will therefore be one crucial pillar in a multi-country cross-cohort comparison and presents a unique opportunity to investigate and compare the patterns that shape health and non-health related outcomes in individuals from four distinct regions in the world.

Study Type

Observational

Enrollment (Actual)

2271

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan, 74800
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will be conducted in Rahimyar Khan (RYK) in Punjab Province, Pakistan and follows a longitudinal birth cohort design that will be conducted alongside a community-based, cluster randomized intervention trial in RYK (NCT02130856). In the concurrent intervention trial, approximately 6000 pregnant women and their unborn babies will be enrolled to participate in either the control or intervention arm of the trial; approximately half of the women will be enrolled to the control arm and half will be enrolled to the intervention arm. At the time of enrolment, women in the control arm of the trial will also be asked to participate in the birth cohort study.

Description

Inclusion Criteria:

  • All pregnant women and their home- or facility-born live newborns that consented to participate in the control arm of the intervention trial "An integrated toolkit to save newborn lives in Pakistan" (NCT02130856) will be eligible for this study

Exclusion Criteria:

  • Did not consent to participate in the control arm of "An integrated toolkit to save newborn lives in Pakistan"(NCT02130856). Since the birth cohort study has been designed to utilize a portion of the data collected in the neonatal kit trial, individuals who do not enroll in the kit study will not be eligible to participate in birth cohort study as they will not have a complete set of data.
  • Failure to provide consent to enroll in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Birth Cohort
The cohort will comprise approximately 3000 pregnant women and their unborn babies, enrolled to participate in the control arm of a cluster-randomized controlled intervention trial (NCT02130856).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality within the first year of life
Time Frame: Day 3 of life, month 6 of life, month 12 of life
Death from any cause within the first year of life. Assessed by questionnaire.
Day 3 of life, month 6 of life, month 12 of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity within the first year of a child's life
Time Frame: Day 3 of life, month 6 of life, month 12 of life
The most common types of illness within the first year of a child's life will be assessed by questionnaire.
Day 3 of life, month 6 of life, month 12 of life
Development/behaviour of children aged 6 and 12 months in RYK, Pakistan
Time Frame: Month 6 of life, month 12 of life

Assessed by questionnaire (12 month by adapted BSID-III)

.
Month 6 of life, month 12 of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Aga Khan University
March of Dimes

Investigators

  • Principal Investigator: Shaun K Morris, MD, MPH, The Hospital for Sick Children
  • Principal Investigator: Zulfiqar A. Bhutta, PhD, MBBS, Aga Khan University and The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

July 22, 2016

Study Completion (Actual)

July 22, 2016

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1000045918

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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