- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00422305
Assessment of Lung Structure and Function of Infants Born Prematurely
연구 개요
상세 설명
SPECIFIC AIM #1:
Determine the relationship between parenchymal tissue and alveolar volume with normal lung growth early in life.
We hypothesize that during the first two years of life that parenchymal surface area and alveolar volume increase with somatic growth; however, the ratio of surface area to volume remains constant, while ventilation within the lung becomes more homogenous.
SPECIFIC AIM #2:
Determine the pulmonary sequelae of premature birth and assess the effectiveness of early treatment strategies upon the pulmonary sequelae.
We hypothesize that premature birth impedes growth and development of the lung parenchyma and the airways. In addition, initiating continuous positive airway pressure (CPAP) and a permissive ventilatory strategy in very premature infants at birth will improve lung growth and lung function compared to treatment with early surfactant and conventional ventilation.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Riley Hospital for Children
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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:
Group 1:
- 37 weeks or greater gestational age
- Age 2 to 36 months
Group 2:
- 37 weeks or greater gestational age having a CT scan for non-respiratory issues.
- Age 2-36 months
Group 3:
- 23-35 weeks gestational age
Exclusion Criteria:
Group 1 and Group 2:
- Congenital cardio-respiratory disease
- Hospitalization for respiratory illness
- Treatment with asthma medications
- Small for gestational age at birth
Group 3:
- Congenital cardio-respiratory disease
- Severe developmental delay
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 단면
코호트 및 개입
그룹/코호트 |
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1-Healthy Infants
Group 1: The investigators will recruit 80 healthy infants born at > 37 weeks gestation, and between 2 and 36 months of age. Infants will be excluded for any of the following reasons:
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2-Healthy Infants computerized Tomography
Group 2: The investigators recruited 4 infants born at > 37 weeks gestation and they were evaluated between 2 and 36 months of age when scheduled for high resolution computed tomography (HRCT) imaging for non-respiratory medical problems. Subjects were enrolled and HRCT of the chest were obtained. Infants were excluded for the following reasons:
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3-Premature Infants
Group 3: The investigators have recruited 45 infants born prematurely at 23-35 weeks gestation. Subjects were evaluated at corrected age at between 2 and 24 months. The subjects had no oxygen requirements, and were clinically stable outpatients when evaluated. Infants were excluded for any of the following reasons:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Pulmonary Function Testing
기간: day of testing
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Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume
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day of testing
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공동 작업자 및 조사자
수사관
- 수석 연구원: Robert S. Tepper, MD, PhD, Indiana 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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0603-15
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