- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01420107
Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)
A video of the delivery room management will be taken using standardized conditions. The video will be evaluated either locally by those directly involved in the delivery room care of this specific infant or anonymously at the main study center. Using a standardized evaluation form a set of predefined interventions is rated regarding at what time they took place and at what time they should have taken place. The difference in time for all interventions is summed up to a score. This score should allow to assess the delivery room management in comparison to the desired standard as well as between hospitals. The evaluation forms of all centers will be analyzed at the main study center to define correlations between certain delivery room interventions and short term outcome.
Aim of the study is to
- gather data on how delivery room care is currently done,
- come closer to an agreement between different NICUs towards what should be done in the delivery room under what circumstances in which way,
- find those interventions with potential influence on short term outcome. Those aspects of management that are different between centers and show correlation with short term outcome will be the focus of future prospective intervention trials in order to find the best way how to take care of preterm infants in the delivery room.
Hypothesis:
In preterm infants <32;0 weeks of gestational age a correlation exists between specific delivery room interventions and short term outcome.
연구 개요
상태
정황
상세 설명
Delivery room interventions measured are: Stimulation, Ventilation, Oxygen, Cardiac massage, Suctioning, ven / art access, fluid and drugs given
Short term outcome measurements are: IVH, PVL, Pneumothorax, BPD, DOL when first time 120mL/kg oral feeds, NEC, ROP, death, Head circumference at discharge
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Greifswald, 독일, 17475
- 모병
- University Children's Hospital
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연락하다:
- Helmut Küster, MD
- 전화번호: -49-3834-86-22476
- 이메일: kuester@uni-greifswald.de
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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:
- preterm infants <32;0 weeks of gestational age
Exclusion Criteria:
- Infants in whom no life support is being planned - e.g. those with lethal malformations
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Delivery Room Management Score (DRMS) negatively correlates with short term outcome (none of (death, IVH °3 or 4, PVL, pneumothorax, BPD, NEC °2 or 3, ROP °3 to 5))
기간: Outcome is measured at first discharge from your hospital
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On special request by the PRS-Team: this is any time between 1 Minute of life in case of delivery room death and up to 2 and more years in case of several complications during the hospital stay.
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Outcome is measured at first discharge from your hospital
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공동 작업자 및 조사자
수사관
- 수석 연구원: Helmut Küster, MD, University Children's Hospital of Greifswald, Germany
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .