Birth Cohort in Coast Province, Kenya

Child Development Clinical Trial

Official title:

A Longitudinal Birth Cohort Study in Coast Province, Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448615
• Other study ID #: 1000047574
• Status: Completed
• Phase: N/A
• First received: May 15, 2015
• Last updated: July 13, 2016
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review BoardKenya: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Child Behaviour
• Child Development
• Morbidity
• Mortality

Locations

Country	Name	City	State
Kenya	Community	Kwale	Coast Province
Kenya	Aga Khan University	Nairobi

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Aga Khan University, Grand Challenges Canada, March of Dimes

Country where clinical trial is conducted

Kenya, 

References & Publications (5)

Brion MJ, Zeegers M, Jaddoe V, Verhulst F, Tiemeier H, Lawlor DA, Smith GD. Intrauterine effects of maternal prepregnancy overweight on child cognition and behavior in 2 cohorts. Pediatrics. 2011 Jan;127(1):e202-11. doi: 10.1542/peds.2010-0651. Epub 2010 Dec 27. — View Citation

Larsen PS, Kamper-Jørgensen M, Adamson A, Barros H, Bonde JP, Brescianini S, Brophy S, Casas M, Charles MA, Devereux G, Eggesbø M, Fantini MP, Frey U, Gehring U, Grazuleviciene R, Henriksen TB, Hertz-Picciotto I, Heude B, Hryhorczuk DO, Inskip H, Jaddoe VW, Lawlor DA, Ludvigsson J, Kelleher C, Kiess W, Koletzko B, Kuehni CE, Kull I, Kyhl HB, Magnus P, Momas I, Murray D, Pekkanen J, Polanska K, Porta D, Poulsen G, Richiardi L, Roeleveld N, Skovgaard AM, Sram RJ, Strandberg-Larsen K, Thijs C, Van Eijsden M, Wright J, Vrijheid M, Andersen AM. Pregnancy and birth cohort resources in europe: a large opportunity for aetiological child health research. Paediatr Perinat Epidemiol. 2013 Jul;27(4):393-414. doi: 10.1111/ppe.12060. Erratum in: Paediatr Perinat Epidemiol. 2013 Sep;27(5):505. Charles, Marie-Aline[added]. — View Citation

Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11. Erratum in: Lancet. 2012 Oct 13;380(9850):1308. — View Citation

Lynch J, Smith GD. A life course approach to chronic disease epidemiology. Annu Rev Public Health. 2005;26:1-35. Review. — View Citation

Paternoster L, Standl M, Chen CM, Ramasamy A, Bønnelykke K, Duijts L, Ferreira MA, Alves AC, Thyssen JP, Albrecht E, Baurecht H, Feenstra B, Sleiman PM, Hysi P, Warrington NM, Curjuric I, Myhre R, Curtin JA, Groen-Blokhuis MM, Kerkhof M, Sääf A, Franke A, Ellinghaus D, Fölster-Holst R, Dermitzakis E, Montgomery SB, Prokisch H, Heim K, Hartikainen AL, Pouta A, Pekkanen J, Blakemore AI, Buxton JL, Kaakinen M, Duffy DL, Madden PA, Heath AC, Montgomery GW, Thompson PJ, Matheson MC, Le Souëf P; Australian Asthma Genetics Consortium (AAGC), St Pourcain B, Smith GD, Henderson J, Kemp JP, Timpson NJ, Deloukas P, Ring SM, Wichmann HE, Müller-Nurasyid M, Novak N, Klopp N, Rodríguez E, McArdle W, Linneberg A, Menné T, Nohr EA, Hofman A, Uitterlinden AG, van Duijn CM, Rivadeneira F, de Jongste JC, van der Valk RJ, Wjst M, Jogi R, Geller F, Boyd HA, Murray JC, Kim C, Mentch F, March M, Mangino M, Spector TD, Bataille V, Pennell CE, Holt PG, Sly P, Tiesler CM, Thiering E, Illig T, Imboden M, Nystad W, Simpson A, Hottenga JJ, Postma D, Koppelman GH, Smit HA, Söderhäll C, Chawes B, Kreiner-Møller E, Bisgaard H, Melén E, Boomsma DI, Custovic A, Jacobsson B, Probst-Hensch NM, Palmer LJ, Glass D, Hakonarson H, Melbye M, Jarvis DL, Jaddoe VW, Gieger C; Genetics of Overweight Young Adults (GOYA) Consortium, Strachan DP, Martin NG, Jarvelin MR, Heinrich J, Evans DM, Weidinger S; EArly Genetics & Lifecourse Epidemiology (EAGLE) Consortium. Meta-analysis of genome-wide association studies identifies three new risk loci for atopic dermatitis. Nat Genet. 2011 Dec 25;44(2):187-92. doi: 10.1038/ng.1017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child mortality within the first year 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)	No
Secondary	Morbidity within the first year of a child's 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)	No
Secondary	Development/behaviour of children aged 6 and 12 months in the Coast Province, Kenya	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	No