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

2017년 7월 14일 업데이트: 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.

연구 개요

상태

완전한

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

관찰

등록 (실제)

51

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

50년 이하 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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).

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Neurodevelopmental scores as measured by the Bayley Scales of Infant Development
기간: 18 months of age
18 months of age

2차 결과 측정

결과 측정
기간
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
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)
기간: 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)
기간: 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)
기간: 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
기간: Neonatal EEG at 1 month of age
Neonatal EEG at 1 month of age

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Ismee A Williams, MD, MS, Columbia University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 12월 1일

기본 완료 (실제)

2014년 11월 1일

연구 완료 (실제)

2016년 1월 1일

연구 등록 날짜

최초 제출

2008년 7월 9일

QC 기준을 충족하는 최초 제출

2008년 7월 10일

처음 게시됨 (추정)

2008년 7월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 7월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 7월 14일

마지막으로 확인됨

2017년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • AAAD1879

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