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NI BabyHearts 2 study protocol: Examining preconceptional and antenatal factors in relation to developmental and educational outcomes of children with and without congenital heart disease NI BabyHearts 2: Study Protocol

  1. 1Ulster University - Belfast Campus

Abstract

BackgroundCongenital heart disease is the most common congenital anomaly and a major public health concern. No single cause has been identified, and its aetiology is most likely to be multifactorial, determined by a combination of genetic and environmental factors. Congenital heart disease can have a significant and lasting impact on childrens health and development with well documented neurodevelopmental difficulties experienced by some children with CHD. However, evidence linking early environmental factors to developmental outcomes remains limited, despite growing recognition of their importance. The Northern Ireland BabyHearts 2 Study provides an opportunity to investigate these relationships in a longitudinal cohort with extensive prospectively collected preconceptional and antenatal data.

AimTo investigate the associations between preconceptional and antenatal environmental factors and the birth outcomes, physical health, neurodevelopment and academic achievement of children with and without congenital heart disease.

MethodsThis is a longitudinal matched cohort follow-up study of children with and without congenital heart disease recruited to the NI BabyHearts 1 case-control study (2014-2017), with controls matched 1:1 by age and sex. Data sources include the existing NI BabyHearts 1 dataset of prospectively collected preconceptional and antenatal environmental exposures, together with linked routine maternity and prescribing data. Direct follow-up data collected at 8-11 years of age included parental questionnaires assessing child executive function and behavioural development, standardised child-completed assessments of neurodevelopment, language and educational attainment, and clinical information.

ImpactThis study will provide evidence on the long-term health and developmental outcomes in children born with and without congenital heart disease and improve understanding of how early environmental factors influence these outcomes. Findings will inform clinical care and service provision for children with congenital heart disease, strengthen preconception and antenatal guidance, and contribute to public health policy aimed at improving long-term outcomes for children living with congenital heart disease.

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BibTeX
@misc{henry2026babyhearts,
  title = {{NI BabyHearts 2 study protocol: Examining preconceptional and antenatal factors in relation to developmental and educational outcomes of children with and without congenital heart disease NI BabyHearts 2: Study Protocol}},
  author = {L.-A. Henry and H. Dolk and J. Given and M. Loane and V. Simms and P. Slater and F. Casey},
  howpublished = {medRxiv},
  year = {2026},
  month = sep,
  doi = {10.64898/2026.09.02.26362009},
  url = {https://www.medrxiv.org/content/10.64898/2026.09.02.26362009v1},
  note = {CC BY},
}
RIS
TY  - UNPB
TI  - NI BabyHearts 2 study protocol: Examining preconceptional and antenatal factors in relation to developmental and educational outcomes of children with and without congenital heart disease NI BabyHearts 2: Study Protocol
AU  - L.-A. Henry
AU  - H. Dolk
AU  - J. Given
AU  - M. Loane
AU  - V. Simms
AU  - P. Slater
AU  - F. Casey
PY  - 2026
DA  - 2026/09/02
PB  - medRxiv
DO  - 10.64898/2026.09.02.26362009
UR  - https://www.medrxiv.org/content/10.64898/2026.09.02.26362009v1
AB  - BackgroundCongenital heart disease is the most common congenital anomaly and a major public health concern. No single cause has been identified, and its aetiology is most likely to be multifactorial, determined by a combination of genetic and environmental factors. Congenital heart disease can have a significant and lasting impact on childrens health and development with well documented neurodevelopmental difficulties experienced by some children with CHD. However, evidence linking early environmental factors to developmental outcomes remains limited, despite growing recognition of their importance. The Northern Ireland BabyHearts 2 Study provides an opportunity to investigate these relationships in a longitudinal cohort with extensive prospectively collected preconceptional and antenatal data.  AimTo investigate the associations between preconceptional and antenatal environmental factors and the birth outcomes, physical health, neurodevelopment and academic achievement of children with and without congenital heart disease.  MethodsThis is a longitudinal matched cohort follow-up study of children with and without congenital heart disease recruited to the NI BabyHearts 1 case-control study (2014-2017), with controls matched 1:1 by age and sex. Data sources include the existing NI BabyHearts 1 dataset of prospectively collected preconceptional and antenatal environmental exposures, together with linked routine maternity and prescribing data. Direct follow-up data collected at 8-11 years of age included parental questionnaires assessing child executive function and behavioural development, standardised child-completed assessments of neurodevelopment, language and educational attainment, and clinical information.  ImpactThis study will provide evidence on the long-term health and developmental outcomes in children born with and without congenital heart disease and improve understanding of how early environmental factors influence these outcomes. Findings will inform clinical care and service provision for children with congenital heart disease, strengthen preconception and antenatal guidance, and contribute to public health policy aimed at improving long-term outcomes for children living with congenital heart disease.
ER  -