Birth Cohort in Coast Province, Kenya

July 13, 2016 updated by: Shaun Morris, The Hospital for Sick Children

A Longitudinal Birth Cohort Study in Coast Province, Kenya

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, the investigators will provide insight into the underlying causes of child mortality by collecting 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, mainly from preventable and treatable conditions (Liu et al., 2012). Notably, the burden of under-five mortality varies dramatically by country. The majority of child deaths are 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). In Kenya, over 120,000 under-5 deaths were estimated in 2010 and approximately 35% of these deaths occurred in the neonatal period.

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 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 circumstances. 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). Notably, by pooling data from multiple cohort studies, causal inferences can be made with greater confidence. For example, if a similar relationship is observed across multiple populations, each with their own distinct set of confounding variables, it is less likely that the observed association is being driven by confounders. 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 Kenya to obtain extensive information on early-life exposures and health and non-health related outcomes in the first year of life.

Study Type

Observational

Enrollment (Actual)

283

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

  • Kenya
      • Nairobi, Kenya
        • Aga Khan University
    • Coast Province
      • Kwale, Coast Province, Kenya
        • Community

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

All pregnant women (and their unborn newborns) who consent to participate in the control arm of the previously approved trial "An integrated toolkit to save newborn lives and brains in Kenya" (NCT02208960) will be eligible for enrollment in this study. At the time of consent, participants will be informed that they are free to consent to the neonatal kit trial without consenting to the birth cohort study.

Description

Inclusion Criteria:

i. All pregnant women and their home- or facility-born live newborns that consent to participate in the control arm of the study "An integrated toolkit to save newborn lives and brains in Kenya" (NCT02208960) will be eligible for this study. The maternal inclusion criteria will be:

  1. All pregnant women in parts of study clusters covered by CHW program and their home- or facility-born live newborns.
  2. Mothers intending to maintain residence in study area for first 12 months of newborn's life.

Exclusion Criteria:

i. Did not consent to participate in the control arm of "An integrated toolkit to save newborn lives and brains in Kenya" (NCT02208960).

ii. 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

Cohorts and Interventions

Group / Cohort
Birth Cohort
The cohort will comprise approximately 1500 pregnant women and their unborn babies, enrolled to participate in the control arm of a cluster-randomized controlled intervention trial (NCT02208960).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child mortality within the first year of life
Time Frame: 12 months (Day 3 of life, Month 6 of life, Month 12 of life)
Death from any cause within the first year of life will be assessed by questionnaire.
12 months (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: 12 months (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.
12 months (Day 3 of life, Month 6 of life, Month 12 of life)
Development/behaviour of children aged 6 and 12 months in the Coast Province, Kenya
Time Frame: Month 6 of life, Month 12 of life
Assessed by questionnaire (month 6) and questionnaire and Kilifi Developmental Inventory at month 12. Linear growth and weight are collected at day 3, month 6 and month 12.
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
Grand Challenges Canada
March of Dimes

Investigators

  • Principal Investigator: Shaun K Morris, MD, MPH, The Hospital for Sick Children
  • Principal Investigator: Robert Armstrong, MD, PhD, Aga Khan University

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

July 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1000047574

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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