The Cork BASELINE Birth Cohort Study (BASELINE)

• ClinicalTrials.gov Identifier: NCT01498965
• Recruitment Status: Unknown
• First Posted: December 26, 2011
• Last Update Posted: January 21, 2015
• Sponsor: National Children's Research Centre, Ireland
• Collaborator: Food Standards Agency, United Kingdom
• Information provided by (Responsible Party): National Children's Research Centre, Ireland

Tracking Information

• First Submitted Date: December 20, 2011
• First Posted Date: December 26, 2011
• Last Update Posted Date: January 21, 2015
• Study Start Date: August 2008
• Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 21, 2011): To establish a longitudinal birth cohort study to examine early life environment and effect on childhood illness [ Time Frame: 24 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 21, 2011)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Cork BASELINE Birth Cohort Study
• Official Title: BASELINE: Babies After Scope: Evaluating the Longitudinal Impact Using Neurological and Nutritional Endpoints
• Brief Summary: 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.

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

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

• 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.

Condition

• Food Allergy
• Eczema
• Obesity

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Hawkes CP, Hourihane JO, Kenny LC, Irvine AD, Kiely M, Murray DM. Gender- and gestational age-specific body fat percentage at birth. Pediatrics. 2011 Sep;128(3):e645-51. doi: 10.1542/peds.2010-3856. Epub 2011 Aug 8.
• O'Donovan SM, Murray DM, Hourihane JO, Kenny LC, Irvine AD, Kiely M. Cohort profile: The Cork BASELINE Birth Cohort Study: Babies after SCOPE: Evaluating the Longitudinal Impact on Neurological and Nutritional Endpoints. Int J Epidemiol. 2015 Jun;44(3):764-75. doi: 10.1093/ije/dyu157. Epub 2014 Aug 7.
• Kelleher MM, O'Carroll M, Gallagher A, Murray DM, Dunn Galvin A, Irvine AD, Hourihane JO. Newborn transepidermal water loss values: a reference dataset. Pediatr Dermatol. 2013 Nov-Dec;30(6):712-6. doi: 10.1111/pde.12106. Epub 2013 Mar 5.
• McCarthy EK, Murray DM, Malvisi L, Kenny LC, O'B Hourihane J, Irvine AD, Kiely ME. Antenatal Vitamin D Status Is Not Associated with Standard Neurodevelopmental Assessments at Age 5 Years in a Well-Characterized Prospective Maternal-Infant Cohort. J Nutr. 2018 Oct 1;148(10):1580-1586. doi: 10.1093/jn/nxy150.
• Norris T, McCarthy FP, Khashan AS, Murray DM, Kiely M, Hourihane JO, Baker PN, Kenny LC; SCOPE Ireland Cohort study and the Cork BASELINE Birth Cohort Study. Do changing levels of maternal exercise during pregnancy affect neonatal adiposity? Secondary analysis of the babies after SCOPE: evaluating the longitudinal impact using neurological and nutritional endpoints (BASELINE) birth cohort (Cork, Ireland). BMJ Open. 2017 Dec 1;7(11):e017987. doi: 10.1136/bmjopen-2017-017987.
• Denihan NM, Looney A, Boylan GB, Walsh BH, Murray DM. Normative levels of Interleukin 16 in umbilical cord blood. Clin Biochem. 2013 Dec;46(18):1857-9. doi: 10.1016/j.clinbiochem.2013.07.012. Epub 2013 Jul 24.
• Walsh BH, Boylan GB, Livingstone V, Kenny LC, Dempsey EM, Murray DM. Cord blood proteins and multichannel-electroencephalography in hypoxic-ischemic encephalopathy. Pediatr Crit Care Med. 2013 Jul;14(6):621-30. doi: 10.1097/PCC.0b013e318291793f.
• Walsh BH, Broadhurst DI, Mandal R, Wishart DS, Boylan GB, Kenny LC, Murray DM. The metabolomic profile of umbilical cord blood in neonatal hypoxic ischaemic encephalopathy. PLoS One. 2012;7(12):e50520. doi: 10.1371/journal.pone.0050520. Epub 2012 Dec 5.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: December 21, 2011): 2185
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: January 2017
• Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Ireland

Administrative Information

• NCT Number: NCT01498965
• Other Study ID Numbers: 2185
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Children's Research Centre, Ireland
• Original Responsible Party: Same as current
• Current Study Sponsor: National Children's Research Centre, Ireland
• Original Study Sponsor: Same as current
• Collaborators: 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; University of Dublin, Trinity College

• PRS Account: National Children's Research Centre, Ireland
• Verification Date: January 2015