The Cork BASELINE Birth Cohort Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Food Standards Agency, United Kingdom
Information provided by (Responsible Party):
National Children's Research Centre, Ireland
ClinicalTrials.gov Identifier:
NCT01498965
First received: December 20, 2011
Last updated: December 21, 2011
Last verified: December 2011
  Purpose

The Departments of Paediatrics and Child Health, Obstetrics/Gynaecology and Nutritional Sciences, University College Cork, and the Department of Dermatology, Trinity College, Dublin have a unique and urgent opportunity to form a birth cohort of over 2000 children whose growth and maternal health status will have been closely monitored from early pregnancy. Longitudinal monitoring of these infants will allow direct investigation of several research areas in a way which has not previously been possible in Ireland, or abroad. The investigators propose to focus on three main research themes: the effects of intrauterine growth restriction, the incidence and prevalence of food allergy and eczema in early childhood and the incidence and effects of maternal and infant vitamin D status on the growth and health of Irish children. Although the investigators initial proposal will focus on these important areas, the formation of this birth cohort will offer many opportunities for further research as the cohort grows older. It will form a unique bio-bank of information from Irish children collected longitudinally from soon after their conception. The mothers of these infants are currently being recruited, which leaves us with a narrow window of opportunity to put in place a pathway of investigation for these children. To ignore this opportunity would be to lose access to a wealth of information regarding child health and disease. The potential for this cohort to provide definitive answers to current, and future, theories of disease causation is enormous.


Condition
Food Allergy
Eczema
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BASELINE: Babies After Scope: Evaluating the Longitudinal Impact Using Neurological and Nutritional Endpoints

Resource links provided by NLM:


Further study details as provided by National Children's Research Centre, Ireland:

Primary Outcome Measures:
  • To establish a longitudinal birth cohort study to examine early life environment and effect on childhood illness [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To establish the prevalence of maternal and neonatal vitamin D deficiency in an Irish paediatric population [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

MAternal DNA, plasma, serum and urine Umbilical serum, plasma, DNA, RNA At 2 years and 5 years: serum, and DNA


Enrollment: 2185
Study Start Date: August 2008
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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:

  1. To establish the fetal and early life growth trajectories which foretell later neurocognitive disability and metabolic disorder
  2. 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.
  3. 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All infants born to mothers enrolled in the SCOPE pregnancy study (www.scopestudy.net) in SCOPE Ireland. First time, low risk mothers with singleton pregnancies.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498965

Locations
Ireland
Department of Paediatrics and Child Health, Cork University Hospital
Cork, Ireland
Sponsors and Collaborators
National Children's Research Centre, Ireland
Food Standards Agency, United Kingdom
Investigators
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 Trinity College, Dublin
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Children's Research Centre, Ireland
ClinicalTrials.gov Identifier: NCT01498965     History of Changes
Other Study ID Numbers: 2185
Study First Received: December 20, 2011
Last Updated: December 21, 2011
Health Authority: Ireland: Research Ethics Committee

Keywords provided by National Children's Research Centre, Ireland:
food allergy
eczema
Vitamin D status
body composition
obesity
neurodevelopmental and behavioural outcome

Additional relevant MeSH terms:
Food Hypersensitivity
Obesity
Body Weight
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 28, 2014