- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04817878
Cohort Construction for Preterm Infants With Growth Retardation and Its Influencing Factors
연구 개요
상세 설명
Preterm infants are at high risk of stunting due to premature birth, insufficient intrauterine nutrient reserves, burden of various diseases after birth, and persistent nutrient liabilities. The growth retardation of premature infants at different developmental stages has an important impact on both short-term survival and long-term health. The growth and development data of premature infants during hospitalization and after discharge are very limited in foreign countries. Domestic researches on growth retardation of preterm infants only involve retrospective cross-sectional studies during hospitalization, and lack of prospective follow-up study data on growth and development data of premature infants during hospitalization and after discharge.
In this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. The regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. The influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed. In order to provide a strong scientific basis for the development evaluation and intervention of premature infants in China, a systematic and scientific clinical cohort study method was explored to improve the overall medical quality and medical level of the Department and further promote the development of the discipline.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: chunling huang, Ph.D.
- 전화번호: +86 13811485908
- 이메일: huangchunling_19@163.com
연구 장소
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Beijing
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Peking, Beijing, 중국, 100191
- 모병
- Peking University Third Hospital
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연락하다:
- chunling huang, Ph.D.
- 전화번호: +86 13811485908
- 이메일: huangchunling_19@163.con
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- All preterm infants born less than 37 weeks during the study period
Exclusion Criteria:
- Congenital malformations or genetic diseases Various surgical treatments during the newborn period Interrupted treatment or discharged automatically
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Late preterm infant group
Gestational age 33 weeks-36 weeks
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Physical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc.
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Very premature infant group
Gestational age 28 weeks-32 weeks
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Physical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc.
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Super preterm infant group
Gestational age less than 28 weeks
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Physical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessment of extrauterine growth retardation of preterm infants at 36-40 weeks of gestational age correction
기간: correct gestational age 36~40 weeks
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According to Fenton 2003 growth curve of premature infants, the weight, length, and head circumference of preterm infants with corrected gestational age of 36-40 weeks were evaluated, If the weight, length and head circumference are lower than the 10th percentile of the corresponding gestational age, the child is diagnosed as EUGR(extrauterine growth retardation)
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correct gestational age 36~40 weeks
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Assessment of neurodevelopmental retardation of preterm infants at 36-40 weeks of gestational age correction
기간: correct gestational age 36~40 weeks
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IF the NBNA score of preterm infants at 36-40 weeks of correction is lower than 36, and the abnormal GMs is evaluated, the child is diagnosed as neurodevelopmental retardation.
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correct gestational age 36~40 weeks
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Assessment of low weight of preterm infants at 2 to 3 years of age
기간: 2~3 years old
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Compared with the same age and gender reference population standard, children's weight below the median minus 2 standard deviations (i.e. less than the 3rd percentile) is diagnosed as low weight
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2~3 years old
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Assessment of growth retardation of preterm infants at 2 to 3 years of age
기간: 2~3 years old
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Compared with the same age and gender reference population standard, children's height below the median minus 2 standard deviations (i.e. less than the 3rd percentile) is diagnosed as growth retardation
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2~3 years old
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Assessment of small head circumference of preterm infants at 2 to 3 years of age
기간: 2~3 years old
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Compared with the same age and gender reference population standard, the children's occipitofrontal circumference (OFC) less than 2 standard deviations (SD) of the mean OFC (i.e. less than the 3rd percentile) is diagnosed as small head circumference
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2~3 years old
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Assessment of neurodevelopmental retardation of preterm infants at 2 to 3 years of age
기간: 2~3 years old
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IF the Wechsler intelligence scales score is lower than 70, the child is diagnosed as neurodevelopmental retardation.
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2~3 years old
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공동 작업자 및 조사자
수사관
- 수석 연구원: xiaomei tong, Ph.D., Peking University Third Hospital
- 연구 책임자: yanmei chang, Ph.D., Peking University Third Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- bysy2020-423-01
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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