The Cork BASELINE Birth Cohort Study (BASELINE)
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| ClinicalTrials.gov Identifier: NCT01498965 |
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Recruitment Status : Unknown
Verified January 2015 by National Children's Research Centre, Ireland.
Recruitment status was: Active, not recruiting
First Posted : December 26, 2011
Last Update Posted : January 21, 2015
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| Condition or disease |
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| Food Allergy Eczema Obesity |
SPECIFIC AIMS:
Our underlying aim is to establish a prospective paediatric birth cohort which will have access to detailed information on maternal health, fetal growth, and childhood nutrition, growth and development in the first 2 years of life. This cohort will have the advantage of a stored biobank of maternal and fetal plasma, serum and DNA. This cohort will allow us to monitor the effects of intrauterine growth and nutrition on early life illnesses.
Our specific aims are:
- To establish the fetal and early life growth trajectories which foretell later neurocognitive disability and metabolic disorder
- To establish the incidence and prevalence of food allergy and eczema in Irish children and investigate the relationship between Vitamin D deficiency and allergic disorders of early childhood.
- To establish the prevalence of maternal and neonatal vitamin D deficiency in an Irish paediatric population
Introduction:
There is increasing evidence that the intrauterine environment has important effects, not only on fetal growth, but also on the life-long health of the child. A term infant is the end result of nine months of immunological and nutritional interplay between the fetus, placenta and mother. Therefore, it is not surprising that this nutritional and hormonal environment has far-reaching effects on childhood health and adult health risk. Fetal nutritional status has been repeatedly linked with adult risk of hypertension, hypercholesterolaemia, Type 2 diabetes and cardiovascular disease. Fetal growth restriction may be associated with neurocognitive delay and long term behavioural problems. We know that maternal vitamin D status has a direct effect on bone growth, not just in neonates, but also on the bone mass and fracture risk of the adolescent offspring. More recently there is some evidence that maternal vitamin D and E deficiency may contribute to a substantial proportion of the increasing incidence of childhood asthma. It is clear, then, that to establish the pathophysiology of many childhood diseases we will need to look back to long before birth.
Previous large birth cohorts in the UK have added greatly to our current knowledge of paediatric health and disease. However the early ALSPAC cohort study examining the "Children of the Nineties" did not have access to the detailed and serial fetal scanning which the SCOPE study will provide to BASELINE. The more recent Southampton Women's Study recruited a similar number of maternal and fetal dyads. The SWS study protocol included fetal scanning and stored DNA, but does not have a cord biobank of serum and plasma samples. The BASELINE study will have access to maternal blood sampling, detailed health questionnaires, serial fetal scanning and multiple aliquots of stored umbilical cord blood. In addition our study will provide reference data in Irish children, something which overseas cohorts can not provide to Irish health care planners and providers.
We believe that the BASELINE study is Ireland's opportunity to establish a longitudinal birth cohort with the potential to answer important questions in the study of diseases in early life, later childhood and beyond. We will be able to identify risk factors for common disorders such as diabetes, eczema and asthma. The BASELINE genetic biobank will allow us to examine candidate genetic markers of disorders as they arise in the cohort. This study has the potential to transform the landscape of paediatric research in Ireland.
| Study Type : | Observational |
| Actual Enrollment : | 2185 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | BASELINE: Babies After Scope: Evaluating the Longitudinal Impact Using Neurological and Nutritional Endpoints |
| Study Start Date : | August 2008 |
| Estimated Primary Completion Date : | October 2016 |
| Estimated Study Completion Date : | January 2017 |
- To establish a longitudinal birth cohort study to examine early life environment and effect on childhood illness [ Time Frame: 24 months ]
- To establish the prevalence of maternal and neonatal vitamin D deficiency in an Irish paediatric population [ Time Frame: 24 months ]Maternal vitamin, Vitamin D at birth in umbilical cord blood, and at 24 months of age
- To establish the incidence and prevalence of food allergy and eczema in Irish children and investigate the relationship between Vitamin D deficiency and allergic disorders of early childhood [ Time Frame: 24 months ]To establish the early life factors, including parental allergy, genetic susceptibility measured using Fillagrin mutational status,skin barrier function and vitamin D status and their effect on risk of eczema and food allergy in the first 2 years of life.
- To establish the fetal and early life growth trajectories which foretell later neurocognitive disability and metabolic disorder [ Time Frame: 24 months ]To examine the relationship between in-utero growth, measured using body composition, and customised birth weight centiles and nerudevelopmental outcome at 24 months. We will also examin risk factors for childhood obesity and metabolic dysfunction at 2 years
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- All liveborn infants whose mothers were recruited to the SCOPE Ireland study at 15 weeks gestation.
- Singleton pregnancies, no previous history or risk of pre-eclampsia
Exclusion Criteria:
- Stillbirths, or mothers who do not consent to paediatric follow up.
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): NCT01498965
| Ireland | |
| Department of Paediatrics and Child Health, Cork University Hospital | |
| Cork, Ireland | |
| Principal Investigator: | Deirdre M Murray, MD. PhD | University College Cork | |
| Study Director: | Jonathan OB Hourihane, MD | University College Cork | |
| Study Director: | Louise K Kenny, PhD | University College Cork | |
| Study Director: | Mairead Kiely, PhD | University College Cork | |
| Study Director: | Alan Irvine, MD. PhD | University of Dublin, Trinity College |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Children's Research Centre, Ireland |
| ClinicalTrials.gov Identifier: | NCT01498965 |
| Other Study ID Numbers: |
2185 |
| First Posted: | December 26, 2011 Key Record Dates |
| Last Update Posted: | January 21, 2015 |
| Last Verified: | January 2015 |
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food allergy eczema Vitamin D status |
body composition obesity neurodevelopmental and behavioural outcome |
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Eczema Food Hypersensitivity Hypersensitivity Immune System Diseases |
Dermatitis Skin Diseases Skin Diseases, Eczematous Hypersensitivity, Immediate |