- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00713635
Prenatal Effects of Congenital Heart Disease (CHD) on Neurodevelopmental Outcome
The Prenatal Effects of Congenital Heart Disease on Neurodevelopmental Outcome
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10032
- Columbia University College of Physicians & Surgeons, Morgan Stanley Children's Hospital of New York
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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:
- Hypoplastic Left Heart Syndrome (HLHS)
- Transposition of the Great Arteries (TGA)
- Tetralogy of Fallot (TOF)
- Lung anomalies consisting of either congenital cystic adenomatoid malformations or bronchogenic cysts
Exclusion Criteria:
- Documented fetal chromosomal anomaly
- Structural brain malformations
- Evidence of placental insufficiency or Intrauterine growth retardation
- Documented hydrops fetalis or sustained cardiac arrhythmias
- Anticipated delivery at an outside hospital
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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1
Fetuses and neonates with congenital heart disease consisting of hypoplastic left heart syndrome (HLHS)
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2
Fetuses and neonates with congenital heart disease consisting of transposition of the great arteries (TGA)
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Fetuses and neonates with congenital heart disease consisting of tetralogy of fallot
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4
Fetuses and neonates with lung masses but without congenital heart disease will serve as a control group
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Neurodevelopmental scores as measured by the Bayley Scales of Infant Development
기간: 18 months of age
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18 months of age
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Neurologic Function as defined by neonatal electroencephalographic power and coherence as measured by a neonatal high-density EEG
기간: Neonatal EEG within 72 hours of birth
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Neonatal EEG within 72 hours of birth
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Neurologic Function as defined by fetal and neonatal autonomic nervous system assessments (fetal heart rate variability and movement coupling and neonatal tilt test)
기간: Fetal assessment between 18-24 wk GA
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Fetal assessment between 18-24 wk GA
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Neurologic Function as defined by fetal and neonatal autonomic nervous system assessments (fetal heart rate variability and movement coupling and neonatal tilt test)
기간: Fetal assessment between 28-32 wk GA
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Fetal assessment between 28-32 wk GA
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Neurologic Function as defined by fetal and neonatal autonomic nervous system assessments (fetal heart rate variability and movement coupling and neonatal tilt test)
기간: Fetal assessment between 34-38 wk GA
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Fetal assessment between 34-38 wk GA
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Neurologic Function as defined by neonatal electroencephalographic power and coherence as measured by a neonatal high-density EEG
기간: Neonatal EEG at 1 month of age
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Neonatal EEG at 1 month of age
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ismee A Williams, MD, MS, Columbia University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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