Food AllergyBASELINENCT01498965
The Cork BASELINE Birth Cohort Study
An observational study of Food Allergy and Eczema, run by National Children's Research Centre, Ireland at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Food Allergy, Eczema, Obesity
- How many people
- 2,185 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2008to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Stillbirths, or mothers who do not consent to paediatric follow up.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Department of Paediatrics and Child Health, Cork University Hospital
Cork
About this study
Official title: BASELINE: Babies After Scope: Evaluating the Longitudinal Impact Using Neurological and Nutritional Endpoints
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.
Read the 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:
- 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.
- Conditions
- Food Allergy, Eczema, Obesity
- Keywords
- food allergy, eczema, Vitamin D status, body composition, obesity, neurodevelopmental and behavioural outcome
- Medical subject headings
- Food Hypersensitivity, Eczema, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish a longitudinal birth cohort study to examine early life environment and effect on childhood illness
Measured: 24 months
Secondary outcomes (3)
To establish the prevalence of maternal and neonatal vitamin D deficiency in an Irish paediatric population
Maternal vitamin, Vitamin D at birth in umbilical cord blood, and at 24 months of age
Measured: 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
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.
Measured: 24 months
To establish the fetal and early life growth trajectories which foretell later neurocognitive disability and metabolic disorder
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startAug 2008
- Primary completionOct 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,185 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Children's Research Centre, Ireland
- Sponsor type
- Research network
- Collaborators
- Food Standards Agency, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Deirdre M Murray, MD. PhD, Principal investigator, University College CorkJonathan OB Hourihane, MD, Study director, University College CorkLouise K Kenny, PhD, Study director, University College CorkMairead Kiely, PhD, Study director, University College CorkAlan Irvine, MD. PhD, Study director, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498965
- Sponsor's protocol ID
- 2185
- Acronym
- BASELINE
- Status last verified
- Jan 2015
- First submitted
- 20 Dec 2011
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21824882O'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.
PubMed 25102856Kelleher 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.
PubMed 23458265O'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.
PubMed 37492907McCarthy 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.
PubMed 30169669Norris 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.
PubMed 29196482Denihan 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.
PubMed 23891891Walsh 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.
PubMed 23823198Walsh 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.
PubMed 23227182
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BASELINE: Babies After Scope: Evaluating the Longitudinal Impact Using Neurological and Nutritional Endpoints
- ClinicalTrials.gov ID
- NCT01498965
- Acronym / sponsor ID
- BASELINE / 2185
- Conditions
- Food Allergy, Eczema, Obesity
- Keywords
- food allergy, eczema, Vitamin D status, body composition, obesity, neurodevelopmental and behavioural outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,185 participants (actual)
- Lead sponsor
- National Children's Research Centre, IrelandResearch network
- Collaborators
- Food Standards Agency, United Kingdom
- Study start
- Aug 2008
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Stillbirths, or mothers who do not consent to paediatric follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To establish a longitudinal birth cohort study to examine early life environment and effect on childhood illness
Time frame: 24 months
3 secondary outcomes
To establish the prevalence of maternal and neonatal vitamin D deficiency in an Irish paediatric population
Time frame: 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
Time frame: 24 months
To establish the fetal and early life growth trajectories which foretell later neurocognitive disability and metabolic disorder
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
- Results publication: PubMed 21824882Hawkes 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.
- Results publication: PubMed 25102856O'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.
- Results publication: PubMed 23458265Kelleher 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.
- Derived from this study: PubMed 37492907O'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.
- Derived from this study: PubMed 30169669McCarthy 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.
- Derived from this study: PubMed 29196482Norris 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.
- Derived from this study: PubMed 23891891Denihan 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.
- Derived from this study: PubMed 23823198Walsh 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.
- Derived from this study: PubMed 23227182Walsh 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.
- The Cork BASELINE Birth Cohort Study home pageLink provided by the sponsor.
- SCOPE pregnancy studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deirdre M Murray, MD. PhD principal investigator
University College Cork
Jonathan OB Hourihane, MD study director
University College Cork
Louise K Kenny, PhD study director
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy and Eczema, run by National Children's Research Centre, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish a longitudinal birth cohort study to examine early life environment and effect on childhood illness (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01498965, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.