The Cork BASELINE Birth Cohort Study

NCT01498965 | Unknown DMC

• 1 other identifier: 2185
• Study Type: observational
• Target: 2,185
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy; Eczema; Obesity

Keywords

food allergy; eczema; Vitamin D status; body composition; obesity; neurodevelopmental and behavioural outcome

Outcome Measures

Primary Outcomes (1)

• To establish a longitudinal birth cohort study to examine early life environment and effect on childhood illness

  24 months

Secondary Outcomes (3)

• To establish the prevalence of maternal and neonatal vitamin D deficiency in an Irish paediatric population

  24 months

• 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

  24 months

• To establish the fetal and early life growth trajectories which foretell later neurocognitive disability and metabolic disorder

  24 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Stillbirths, or mothers who do not consent to paediatric follow up.

Sponsors & Collaborators

• National Children's Research Centre, Ireland: lead
• Food Standards Agency, United Kingdom: collaborator

Study Sites (1)

Department of Paediatrics and Child Health, Cork University Hospital

Cork, Ireland

Location

Related Publications (9)

• 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.

  PMID: 21824882 RESULT

• 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.

  PMID: 25102856 RESULT

• 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.

  PMID: 23458265 RESULT

• O'Connor C, Livingstone V, O'B Hourihane J, Irvine AD, Boylan G, Murray D. Early emollient bathing is associated with subsequent atopic dermatitis in an unselected birth cohort study. Pediatr Allergy Immunol. 2023 Jul;34(7):e13998. doi: 10.1111/pai.13998.

  PMID: 37492907 DERIVED

• 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.

  PMID: 30169669 DERIVED

• 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.

  PMID: 29196482 DERIVED

• 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.

  PMID: 23891891 DERIVED

• 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.

  PMID: 23823198 DERIVED

• 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.

  PMID: 23227182 DERIVED

Related Links

• The Cork BASELINE Birth Cohort Study home page
• SCOPE pregnancy study

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

MeSH Terms

Conditions

Food Hypersensitivity; Eczema; Obesity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deirdre M Murray, MD. PhD

  University College Cork

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 26, 2011
• Study Start: August 1, 2008
• Primary Completion: October 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

IE (1)