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Prenatal Effects of Congenital Heart Disease (CHD) on Neurodevelopmental Outcome

14 de julho de 2017 atualizado por: Columbia University

The Prenatal Effects of Congenital Heart Disease on Neurodevelopmental Outcome

The purpose of this study is to investigate the prenatal impact of abnormal cardiac structure on neurodevelopmental outcomes in children with congenital heart disease.

Visão geral do estudo

Status

Concluído

Descrição detalhada

Congenital heart disease (CHD) is the most common class of birth defect and is a major cause of infant and child death and morbidity, including neurodevelopmental delay. Children with severe forms of CHD are at high risk for a spectrum of neurocognitive difficulties that include learning disability, attention deficit and hyperactivity disorder, behavioral problems and mental retardation. The etiology of neurodevelopmental delay in children with CHD is not fully understood but is thought to be secondary to a combination of pre- and post-natal insults to the brain. It has been observed that fetuses with severe forms of CHD have abnormal blood flow to the brain as measured by Doppler ultrasound. This "centralization" or redirection of blood flow toward vital organs such as the brain has been shown to lead to abnormal brain development in other fetal diseases, such as intrauterine growth restriction. Evidence of the importance of prenatal brain development in the setting of CHD is amounting. Neonates with complex CHD demonstrate abnormalities of brain structure and blood flow prior to cardiothoracic surgery. However, to date, associations between abnormal fetal brain blood flow and neonatal neurologic outcomes and brain function have not been established in the CHD population. Finally, newborns with CHD have been shown to have abnormalities in heart rate over a 24 hour period. This finding suggests that the autonomic nervous system, which controls heart rate and blood pressure, may not function properly in infants with CHD.

The study proposes that these changes in blood flows in the fetus with heart disease could be responsible in part for poor brain growth, abnormal brain structure and function and developmental delay in childhood. Investigators will use routine obstetrical ultrasound and fetal echocardiograms to evaluate blood flow to vital organs and brain growth in fetuses with CHD. Investigators will use non-invasive fetal monitors to measure fetal heart rate and movement. Investigators will look at brain structure using Magnetic Resonance Imaging (MRI) in the fetus and newborn. Afterbirth, investigators will use non-invasive monitors to measure neonatal heart rate and blood pressure changes in response to a tilt, similar to what is experienced when placing an infant in a car seat. Investigators will use a non-invasive monitor consisting of a sticker applied to the skin to measure the level of oxygen in the brain. Investigators will also measure brain function in the newborn with an electroencephalogram(EEG) that records the electrical signaling between different parts of the brain using a special plastic hat like a swim cap. Regular physical exams with a pediatrician to measure growth and development will take place. A special test designed to detect learning disabilities will also be done when the child is 14 months old. This test will consist of talking with the child, reading stories, and showing the child pictures and colors. There will be no extra blood tests needed and none of the tests pose any risk to the mother, fetus, infant, or child.

The possible benefits to the child and the family will be early identification of any brain abnormality in the newborn period as well as learning disabilities in the toddler which will then allow the child to receive therapies designed to treat these problems. Studies show that early identification and treatment of learning disabilities are important to enhance the potential of the child.

Tipo de estudo

Observacional

Inscrição (Real)

51

Contactos e Locais

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Locais de estudo

    • New York
      • New York, New York, Estados Unidos, 10032
        • Columbia University College of Physicians & Surgeons, Morgan Stanley Children's Hospital of New York

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Não mais velho que 50 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Study subjects will consist of mothers and infants referred to the Morgan Stanley Children's Hospital of New York-Presbyterian for evaluation of complex congenital heart disease consisting of: 1) single ventricle variant, such as hypoplastic left heart (HLHS); 2) Tetralogy of Fallot; 3) Transposition of the Great Vessels, and 4)Lung anomalies. Investigators anticipate that 24 mothers and 24 fetuses/infants will be enrolled during the period of study. This will give the study team a total of 24 women-fetus/infant dyads or 48 subjects total (if one counts the mother and the fetus/infant separately).

Descrição

Inclusion Criteria:

  1. All women who present to Columbia University Medical Center between 18-24 wks gestational age with the following fetal diagnoses will be invited to participate:
  2. Hypoplastic Left Heart Syndrome (HLHS)
  3. Transposition of the Great Arteries (TGA)
  4. Tetralogy of Fallot (TOF)
  5. Lung anomalies consisting of either congenital cystic adenomatoid malformations or bronchogenic cysts

Exclusion Criteria:

  1. Documented fetal chromosomal anomaly
  2. Structural brain malformations
  3. Evidence of placental insufficiency or Intrauterine growth retardation
  4. Documented hydrops fetalis or sustained cardiac arrhythmias
  5. Anticipated delivery at an outside hospital

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
1
Fetuses and neonates with congenital heart disease consisting of hypoplastic left heart syndrome (HLHS)
2
Fetuses and neonates with congenital heart disease consisting of transposition of the great arteries (TGA)
3
Fetuses and neonates with congenital heart disease consisting of tetralogy of fallot
4
Fetuses and neonates with lung masses but without congenital heart disease will serve as a control group

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Neurodevelopmental scores as measured by the Bayley Scales of Infant Development
Prazo: 18 months of age
18 months of age

Medidas de resultados secundários

Medida de resultado
Prazo
Neurologic Function as defined by neonatal electroencephalographic power and coherence as measured by a neonatal high-density EEG
Prazo: Neonatal EEG within 72 hours of birth
Neonatal EEG within 72 hours of birth
Neurologic Function as defined by fetal and neonatal autonomic nervous system assessments (fetal heart rate variability and movement coupling and neonatal tilt test)
Prazo: Fetal assessment between 18-24 wk GA
Fetal assessment between 18-24 wk GA
Neurologic Function as defined by fetal and neonatal autonomic nervous system assessments (fetal heart rate variability and movement coupling and neonatal tilt test)
Prazo: Fetal assessment between 28-32 wk GA
Fetal assessment between 28-32 wk GA
Neurologic Function as defined by fetal and neonatal autonomic nervous system assessments (fetal heart rate variability and movement coupling and neonatal tilt test)
Prazo: Fetal assessment between 34-38 wk GA
Fetal assessment between 34-38 wk GA
Neurologic Function as defined by neonatal electroencephalographic power and coherence as measured by a neonatal high-density EEG
Prazo: Neonatal EEG at 1 month of age
Neonatal EEG at 1 month of age

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Ismee A Williams, MD, MS, Columbia University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de dezembro de 2010

Conclusão Primária (Real)

1 de novembro de 2014

Conclusão do estudo (Real)

1 de janeiro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

9 de julho de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de julho de 2008

Primeira postagem (Estimativa)

11 de julho de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de julho de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de julho de 2017

Última verificação

1 de julho de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • AAAD1879

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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