- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00009633
고위험 영아의 후속 방문 (FU)
연구 개요
상세 설명
NICHD 신생아 연구 네트워크의 후속 연구는 다기관 코호트 연구로 생존한 극소 저체중아가 교정 연령 22-26개월에 신경 발달, 신경 감각 및 기능 평가를 받습니다(2012년 7월 1일 이전에 태어난 영아는 18-22개월 수정 연령). 이 연구의 목표는 다음을 포함하여 유아의 신경 발달에 영향을 미칠 수 있는 잠재적인 산모 및 신생아 위험 요소를 식별하는 것입니다.
- 운동 능력, 인지 능력, 언어 및 행동의 발달 평가
- 사망 및 특정 의학적 상태의 유병률 결정
- 성장과 신경 발달 결과 사이의 관계 평가
- 사회 경제적 지위와 발달 결과 간의 관계 평가
- 이 모집단의 특별 지원 서비스 및 조기 개입 프로그램 사용 평가
- 취학 연령에 대한 후속 조치의 필요성 평가.
예정된 평가는 다음을 수집합니다. 사회경제적 지위; 병력; 약물; 필요한 의료 장비; 성장 데이터; 상세한 신경학적 검사; 베일리 유아 발달 척도(정신, 운동, 유아 행동); 아동 행동 체크리스트.
하위 연구는 다음 세 가지 목표를 충족하기 위해 네트워크 센터에서 태어난 제한된 수의 건강한 만삭아로 구성된 참조 그룹을 평가할 것입니다. 2) Bayley 척도에 대한 잘 발달된 규범이 없는 경우, 우리 센터에서 만삭에 태어난 건강한 어린이의 대표 샘플에 대한 데이터를 기반으로 장애 임계값을 정의하고 동시에 우리의 높은 위험 유아; 3) Bayley 평가를 수행하고 채점할 때 시간이 지남에 따라 "드리프트"가 발생하는 경우를 식별하고 해결하는 데 도움이 됩니다.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Susan R Hintz, MD, MS Epi
- 이메일: srhintz@stanford.edu
연구 연락처 백업
- 이름: Abhik Das, PhD
- 전화번호: 301 230 4640
- 이메일: adas@rti.org
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35233
- 모병
- University of Alabama at Birmingham
-
연락하다:
- Waldemar A. Carlo, MD
-
수석 연구원:
- Myriam Peralta-Carcelen, MD MPH
-
수석 연구원:
- Waldemar A. Carlo, MD
-
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California
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Los Angeles, California, 미국, 90025
- 모병
- University of California - Los Angeles
-
연락하다:
- Uday Devaskar, MD
-
수석 연구원:
- Uday Devaskar, MD
-
수석 연구원:
- Isabell Purdy, MD
-
Palo Alto, California, 미국, 94304
- 모병
- Stanford University
-
연락하다:
- Krisa P. Van Meurs, MD
-
수석 연구원:
- Krisa P. Van Meurs, MD
-
수석 연구원:
- Susan R. Hintz, MD
-
San Diego, California, 미국, 92123
- 아직 모집하지 않음
- Sharp Mary Birch Hospital for Women & Newborns
-
연락하다:
- Anup Katheria, MD
-
수석 연구원:
- Anup Katheria, MD
-
San Diego, California, 미국, 92103-8774
- 완전한
- University of California at San Diego
-
-
Connecticut
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New Haven, Connecticut, 미국, 06504
- 완전한
- Yale University
-
-
District of Columbia
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Washington D.C., District of Columbia, 미국, 20052
- 완전한
- George Washington University
-
-
Florida
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Miami, Florida, 미국, 33136
- 완전한
- University of Miami
-
-
Georgia
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Atlanta, Georgia, 미국, 30303
- 모병
- Emory University
-
연락하다:
- David P. Carlton, MD
-
수석 연구원:
- David P. Carlton, MD
-
수석 연구원:
- Ira Adams-Chapman, MD
-
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Illinois
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Chicago, Illinois, 미국, 60611
- 아직 모집하지 않음
- Northwestern Lurie Children's Hospital of Chicago
-
연락하다:
- Aaron Hamvas, MD
-
수석 연구원:
- Aaron Hamvas, MD
-
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Indiana
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Indianapolis, Indiana, 미국, 46202
- 모병
- Indiana University
-
수석 연구원:
- Greg Sokol, MD
-
수석 연구원:
- Heidi Harmon, MD
-
연락하다:
- Greg Sokol, MD
-
-
Iowa
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Iowa City, Iowa, 미국, 52242
- 모병
- University of Iowa
-
연락하다:
- Edward F. Bell, MD
-
수석 연구원:
- Edward F. Bell, MD
-
수석 연구원:
- Jane E. Brumbaugh, MD
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Massachusetts
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Boston, Massachusetts, 미국, 02111
- 완전한
- Tufts Medical Center
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Cambridge, Massachusetts, 미국, 02138
- 완전한
- Harvard University
-
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Michigan
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Detroit, Michigan, 미국, 48201
- 모병
- Wayne State University
-
연락하다:
- Seetha Shankaran, MD
-
수석 연구원:
- Seetha Shankaran, MD
-
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Mississippi
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Jackson, Mississippi, 미국, 39216
- 아직 모집하지 않음
- University of Mississippi Medical Center - Children's of Mississippi
-
수석 연구원:
- Abhay Bhatt, MD
-
연락하다:
- Abhay Bhatt, MD
-
-
Missouri
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Kansas City, Missouri, 미국, 64108
- 모병
- Children's Mercy Hospital
-
연락하다:
- William Truog, MD
-
수석 연구원:
- William Truog, MD
-
수석 연구원:
- Howard Kilbride, MD
-
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New Mexico
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Albuquerque, New Mexico, 미국, 87131
- 모병
- University of New Mexico
-
연락하다:
- Kristi L. Watterberg, MD
-
수석 연구원:
- Kristi L. Watterberg, MD
-
수석 연구원:
- Janell Fuller, MD
-
수석 연구원:
- Jean Lowe, MD
-
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New York
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Rochester, New York, 미국, 14642
- 모집하지 않고 적극적으로
- University of Rochester
-
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North Carolina
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Charlotte, North Carolina, 미국, 27157
- 완전한
- Wake Forest University
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Durham, North Carolina, 미국, 27710
- 모병
- Duke University
-
연락하다:
- C. Michael Cotten, MD
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수석 연구원:
- C. Michael Cotten, MD
-
수석 연구원:
- William F. Malcolm, MD
-
Durham, North Carolina, 미국, 27705
- 모집하지 않고 적극적으로
- RTI International
-
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Ohio
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Cincinnati, Ohio, 미국, 45267
- 모병
- Cincinnati Children's Medical Center
-
수석 연구원:
- Stephanie Merhar, MD
-
연락하다:
- Brenda Poindexter, MD,MS
-
수석 연구원:
- Brenda Poindexter, MD
-
수석 연구원:
- Kimberly Yolton, PhD
-
Cleveland, Ohio, 미국, 44106
- 모병
- Case Western Reserve University, Rainbow Babies and Children's Hospital
-
연락하다:
- Michele C. Walsh, MD MS
-
수석 연구원:
- Michele C. Walsh, MD MS
-
수석 연구원:
- Deanne E. Wilson, MD
-
Columbus, Ohio, 미국, 43205
- 모집하지 않고 적극적으로
- Research Institute at Nationwide Children's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- 모병
- University of Pennsylvania
-
연락하다:
- Eric Eichenwald, MD
-
수석 연구원:
- Eric Eichenwald, MD
-
수석 연구원:
- Sara DeMauro, MD
-
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Rhode Island
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Providence, Rhode Island, 미국, 02905
- 모집하지 않고 적극적으로
- Brown University, Women & Infants Hospital of Rhode Island
-
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Tennessee
-
Memphis, Tennessee, 미국, 38163
- 완전한
- University of Tennessee
-
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Texas
-
Dallas, Texas, 미국, 75235
- 모병
- University Of Texas Southwestern Medical Center At Dallas
-
연락하다:
- Myra H Wyckoff, MD
-
수석 연구원:
- Myra H. Wyckfoff, MD
-
수석 연구원:
- Roy J. Heyne, MD
-
Houston, Texas, 미국, 77030
- 모병
- University of Texas Health Science Center at Houston
-
연락하다:
- Jon Tyson, MD MPH
-
수석 연구원:
- Jon E. Tyson, MD MPH
-
수석 연구원:
- Andrea F. Duncan, MD
-
-
Utah
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Salt Lake City, Utah, 미국, 84108
- 모병
- University of Utah
-
연락하다:
- Bradley Yoder, MD
-
수석 연구원:
- Sara Winter, MD
-
수석 연구원:
- Bradley Yoder, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
- NRN 센터에서 태어난 유아
- 재태 연령 27주 미만
- 하나 이상의 추가 NICHD NRN 후속 연구에 등록된 유아. 위의 포함 기준을 충족하지 않는 영아의 경우 포함 및 제외 기준은 추가 시험 기준에 따라 결정됩니다. 이러한 경우, 1,000g 이상 및/또는 27주 이상의 영아가 FU 연구에 포함될 수 있습니다.
참고: 이러한 포함 기준은 2008년 1월 1일부터 변경되었습니다. 이 날짜 이전에는 출생 후 14일 이내에 NRN NICU에 입원한 출생 체중 401~1500g의 영아가 데이터베이스에 포함되었습니다.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
레지스트리 코호트
|
간섭 없음
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
균일한 방식으로 수집된 데이터로 VLBW 영아에 대한 기준 및 결과 데이터의 레지스트리를 유지하기 위해
기간: 종단 데이터베이스는 현재 2016년 3월 31일까지 자금이 지원됩니다.
|
종단 데이터베이스는 현재 2016년 3월 31일까지 자금이 지원됩니다.
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
기준 특성과 결과 사이의 관계를 조사하기 위해
기간: 종단 데이터베이스는 현재 2016년 3월 31일까지 자금이 지원됩니다.
|
종단 데이터베이스는 현재 2016년 3월 31일까지 자금이 지원됩니다.
|
|
네트워크 다기관 연구를 위한 가설 공식화 및 표본 크기 계산을 위한 데이터 제공
기간: 종단 데이터베이스는 현재 2016년 3월 31일까지 자금이 지원됩니다.
|
종단 데이터베이스는 현재 2016년 3월 31일까지 자금이 지원됩니다.
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: C. Michael Cotten, MD, MHS, Duke University
- 수석 연구원: David P. Carlton, MD, Emory University
- 수석 연구원: Brenda B. Poindexter, MD, Children's Hospital Medical Center, Cincinnati
- 수석 연구원: Myra H. Wyckoff, MD, University of Texas, Southwestern Medical Center at Dallas
- 수석 연구원: Bradley A. Yoder, MD, University of Utah
- 수석 연구원: William E. Truog, MD, Children's Mercy Hospital Kansas City
- 수석 연구원: Pablo J. Sanchez, MD, Research Institute at Nationwide Children's Hospital
- 수석 연구원: Eric C Eichenwald, MD, University of Pennsylvania
- 수석 연구원: Seetha Shankaran, MD, Wayne State University
- 수석 연구원: Abbot R. Laptook, MD, Brown University, Women & Infants Hospital of Rhode Island
- 수석 연구원: Michele C. Walsh, MD MS, Case Western Reserve University, Rainbow Babies and Children's Hospital
- 수석 연구원: Greg M. Sokol, MD, Indiana University
- 수석 연구원: Abhik Das, PhD, RTI International
- 수석 연구원: Krisa P. Van Meurs, MD, Stanford University
- 수석 연구원: Waldemar A. Carlo, MD, University of Alabama at Birmingham
- 수석 연구원: Edward F. Bell, MD, University of Iowa
- 수석 연구원: Kristi L. Watterberg, MD, University of New Mexico
- 수석 연구원: Jon E Tyson, MD, MPH, The University of Texas Health Science Center, Houston
- 수석 연구원: Uday Devaskar, MD, University of California, Los Angeles
- 수석 연구원: Carl T D'Angio, MD, University of Rochester
간행물 및 유용한 링크
일반 간행물
- Malcolm WF, Gantz M, Martin RJ, Goldstein RF, Goldberg RN, Cotten CM; National Institute of Child Health and Human Development Neonatal Research Network. Use of medications for gastroesophageal reflux at discharge among extremely low birth weight infants. Pediatrics. 2008 Jan;121(1):22-7. doi: 10.1542/peds.2007-0381.
- Adams-Chapman I, Hansen NI, Stoll BJ, Higgins R; NICHD Research Network. Neurodevelopmental outcome of extremely low birth weight infants with posthemorrhagic hydrocephalus requiring shunt insertion. Pediatrics. 2008 May;121(5):e1167-77. doi: 10.1542/peds.2007-0423. Epub 2008 Apr 7.
- Benjamin DK Jr, Stoll BJ, Fanaroff AA, McDonald SA, Oh W, Higgins RD, Duara S, Poole K, Laptook A, Goldberg R; National Institute of Child Health and Human Development Neonatal Research Network. Neonatal candidiasis among extremely low birth weight infants: risk factors, mortality rates, and neurodevelopmental outcomes at 18 to 22 months. Pediatrics. 2006 Jan;117(1):84-92. doi: 10.1542/peds.2004-2292.
- Broitman E, Ambalavanan N, Higgins RD, Vohr BR, Das A, Bhaskar B, Murray K, Hintz SR, Carlo WA; National Institute of Child Health and Human Development Neonatal Research Network. Clinical data predict neurodevelopmental outcome better than head ultrasound in extremely low birth weight infants. J Pediatr. 2007 Nov;151(5):500-5, 505.e1-2. doi: 10.1016/j.jpeds.2007.04.013. Epub 2007 Jul 12.
- Castro L, Yolton K, Haberman B, Roberto N, Hansen NI, Ambalavanan N, Vohr BR, Donovan EF. Bias in reported neurodevelopmental outcomes among extremely low birth weight survivors. Pediatrics. 2004 Aug;114(2):404-10. doi: 10.1542/peds.114.2.404.
- Cole CR, Hansen NI, Higgins RD, Ziegler TR, Stoll BJ; Eunice Kennedy Shriver NICHD Neonatal Research Network. Very low birth weight preterm infants with surgical short bowel syndrome: incidence, morbidity and mortality, and growth outcomes at 18 to 22 months. Pediatrics. 2008 Sep;122(3):e573-82. doi: 10.1542/peds.2007-3449.
- Da Costa D, Bann CM, Hansen NI, Shankaran S, Delaney-Black V; National Institute of Child Health and Human Development Neonatal Research Network. Validation of the Functional Status II questionnaire in the assessment of extremely-low-birthweight infants. Dev Med Child Neurol. 2009 Jul;51(7):536-44. doi: 10.1111/j.1469-8749.2009.03318.x.
- Ehrenkranz RA, Walsh MC, Vohr BR, Jobe AH, Wright LL, Fanaroff AA, Wrage LA, Poole K; National Institutes of Child Health and Human Development Neonatal Research Network. Validation of the National Institutes of Health consensus definition of bronchopulmonary dysplasia. Pediatrics. 2005 Dec;116(6):1353-60. doi: 10.1542/peds.2005-0249.
- Gargus RA, Vohr BR, Tyson JE, High P, Higgins RD, Wrage LA, Poole K. Unimpaired outcomes for extremely low birth weight infants at 18 to 22 months. Pediatrics. 2009 Jul;124(1):112-21. doi: 10.1542/peds.2008-2742.
- Heller CD, O'Shea M, Yao Q, Langer J, Ehrenkranz RA, Phelps DL, Poole WK, Stoll B, Duara S, Oh W, Lemons J, Poindexter B; NICHD Neonatal Research Network. Human milk intake and retinopathy of prematurity in extremely low birth weight infants. Pediatrics. 2007 Jul;120(1):1-9. doi: 10.1542/peds.2006-1465.
- Hintz SR, Kendrick DE, Vohr BR, Poole WK, Higgins RD; National Institute of Child Health and Human Development (NICHD) Neonatal Research Network. Community supports after surviving extremely low-birth-weight, extremely preterm birth: special outpatient services in early childhood. Arch Pediatr Adolesc Med. 2008 Aug;162(8):748-55. doi: 10.1001/archpedi.162.8.748.
- Hintz SR, Kendrick DE, Stoll BJ, Vohr BR, Fanaroff AA, Donovan EF, Poole WK, Blakely ML, Wright L, Higgins R; NICHD Neonatal Research Network. Neurodevelopmental and growth outcomes of extremely low birth weight infants after necrotizing enterocolitis. Pediatrics. 2005 Mar;115(3):696-703. doi: 10.1542/peds.2004-0569.
- Hintz SR, Kendrick DE, Vohr BR, Poole WK, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Changes in neurodevelopmental outcomes at 18 to 22 months' corrected age among infants of less than 25 weeks' gestational age born in 1993-1999. Pediatrics. 2005 Jun;115(6):1645-51. doi: 10.1542/peds.2004-2215.
- Hintz SR, Kendrick DE, Vohr BR, Kenneth Poole W, Higgins RD; Nichd Neonatal Research Network. Gender differences in neurodevelopmental outcomes among extremely preterm, extremely-low-birthweight infants. Acta Paediatr. 2006 Oct;95(10):1239-48. doi: 10.1080/08035250600599727.
- Lainwala S, Perritt R, Poole K, Vohr B; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth outcomes of extremely low birth weight infants who are transferred from neonatal intensive care units to level I or II nurseries. Pediatrics. 2007 May;119(5):e1079-87. doi: 10.1542/peds.2006-0899. Epub 2007 Apr 2.
- Laptook AR, O'Shea TM, Shankaran S, Bhaskar B; NICHD Neonatal Network. Adverse neurodevelopmental outcomes among extremely low birth weight infants with a normal head ultrasound: prevalence and antecedents. Pediatrics. 2005 Mar;115(3):673-80. doi: 10.1542/peds.2004-0667.
- Lowe J, Woodward B, Papile LA. Emotional regulation and its impact on development in extremely low birth weight infants. J Dev Behav Pediatr. 2005 Jun;26(3):209-13. doi: 10.1097/00004703-200506000-00008.
- Madan JC, Kendrick D, Hagadorn JI, Frantz ID 3rd; National Institute of Child Health and Human Development Neonatal Research Network. Patent ductus arteriosus therapy: impact on neonatal and 18-month outcome. Pediatrics. 2009 Feb;123(2):674-81. doi: 10.1542/peds.2007-2781.
- Morris BH, Gard CC, Kennedy K; NICHD Neonatal Research Network. Rehospitalization of extremely low birth weight (ELBW) infants: are there racial/ethnic disparities? J Perinatol. 2005 Oct;25(10):656-63. doi: 10.1038/sj.jp.7211361.
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기타 연구 ID 번호
- NICHD-NRN-0007
- UG1HD034216 (미국 NIH 보조금/계약)
- UG1HD027904 (미국 NIH 보조금/계약)
- UG1HD021364 (미국 NIH 보조금/계약)
- UG1HD027853 (미국 NIH 보조금/계약)
- UG1HD040689 (미국 NIH 보조금/계약)
- UG1HD040492 (미국 NIH 보조금/계약)
- UG1HD027851 (미국 NIH 보조금/계약)
- UG1HD053109 (미국 NIH 보조금/계약)
- UG1HD068278 (미국 NIH 보조금/계약)
- UG1HD068244 (미국 NIH 보조금/계약)
- UG1HD068263 (미국 NIH 보조금/계약)
- UG1HD027880 (미국 NIH 보조금/계약)
- UG1HD053089 (미국 NIH 보조금/계약)
- UG1HD087226 (미국 NIH 보조금/계약)
- UG1HD112079 (미국 NIH 보조금/계약)
- UG1HD112097 (미국 NIH 보조금/계약)
- UG1HD112100 (미국 NIH 보조금/계약)
- U24HD095254 (미국 NIH 보조금/계약)
- UG1HD112093 (미국 NIH 보조금/계약)
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