Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV) (NIPPV)
Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants
The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.
Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.
The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?
연구 개요
상세 설명
The immature lung of extremely low birth weight (ELBW, < 1000 g) infants is easily damaged by the placement of an endotracheal tube to deliver mechanical ventilation and oxygen. This and the total time of mechanical ventilation contributes to bronchopulmonary dysplasia (BPD). Infants with BPD have an increased risk of later death or neuro-impairment. With the increasing survival of ELBW infants in the NICU, there has been a proportionate increase in the number of infants surviving with BPD.
Following invasive ventilation via an endotracheal tube (ETT), extubation to nasal Continuous Positive Airway Pressure (nCPAP)ventilation is the standard approach. Currently, 40% of infants who are extubated and given nCPAP support fail, and require re-intubation. Previous work suggests that a less invasive respiratory support such as Nasal Intermittent Positive Pressure Ventilation (NIPPV), without an endotracheal tube is less injurious to the lung. NIPPV may thereby reduce the duration of invasive ventilator support, and aid successful early extubation. We hypothesize that the use of NIPPV leads to a higher rate of survival without BPD than standard therapy with nCPAP.
This randomized clinical trial is appropriately powered to compare NIPPV with nCPAP to detect effects on clinically relevant long-term outcomes, such as death and BPD at 36 weeks. This is a multi-national, randomized, open clinical trial of two different standard methods of providing non-invasive respiratory support to 1000 extremely preterm infants weighing less than 1000 grams at birth.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
-
Groningen, 네덜란드, 9700 RB
- University Medical Center Groningen/Beatrix Children's Hosp
-
Zwolle, 네덜란드, 8000 GK
- Princess Amalia Dept of Pediatrics, Isala Clinics
-
-
-
-
District of Columbia
-
Washington, District of Columbia, 미국, 20037
- The George Washington University Hospital
-
Washington, District of Columbia, 미국, 20007
- Georgetown University Children's Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Medical Center (BIDMC)
-
Boston, Massachusetts, 미국, 02111
- Tufts University Medical Center
-
-
New Jersey
-
Voorhees, New Jersey, 미국, 08043
- Virtua West Jersey Hospital
-
-
New York
-
Brooklyn, New York, 미국, 11203
- Kings County Hospital
-
Brooklyn, New York, 미국, 11023
- SUNY Downstate Medical Center
-
Brooklyn, New York, 미국, 11355
- New York Hospital Queens
-
Jamaica, New York, 미국, 11432
- Queens Hospital Center
-
New York, New York, 미국, 11212
- Brookdale University Hospital & Medical Center
-
Stony Brook, New York, 미국, 11794-8111
- Stony Brook University Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, 미국, 19035
- Pennsylvania Hospital/U. of Pennsylvania
-
-
Utah
-
Salt Lake City, Utah, 미국, 84158-1289
- University of Utah
-
-
-
-
-
Rocourt, 벨기에, B-4000
- CHC St. Vincent
-
-
-
-
-
Stockholm, 스웨덴, S-171 76
- Karolinska University Hospital/Astrid Lingrenn's Children's Hospital
-
-
-
-
-
Singapore, 싱가포르, 229899
- KK Women's and Children's Hospital
-
-
-
-
-
Dublin, 아일랜드
- National Maternity Hospital
-
Dublin, 아일랜드
- Coombe Women's Hospital
-
-
Cork
-
Wilton, Cork, 아일랜드
- Cork University Maternity Hospital
-
-
-
-
-
Leicester, 영국, LE1 6TP
- University of Leicester
-
London, 영국, W2 1NY
- St. Mary's Hospital
-
-
Northern Ireland
-
Belfast, Northern Ireland, 영국, BT12 6BB
- Royal Maternity Hospital
-
-
-
-
-
Feldkirch, 오스트리아, 6800
- LKH Feldkirch
-
-
-
-
-
Doha, 카타르
- Hamad Medical Corporation
-
-
-
-
Manitoba
-
Winnipeg, Manitoba, 캐나다
- Winnipeg Health Sciences Centre
-
Winnipeg, Manitoba, 캐나다, R3E 0L8
- St. Boniface General Hospital/University of Manitoba
-
-
Nova Scotia
-
Halifax, Nova Scotia, 캐나다
- IWK Health Centre
-
-
Ontario
-
Hamilton, Ontario, 캐나다, L8S 4J9
- McMaster University
-
Ottawa, Ontario, 캐나다, K1H 8L1
- Children'S Hospital Of Eastern Ontario
-
Ottawa, Ontario, 캐나다, K1H 8L6
- The Ottawa Hospital General Campus
-
Toronto, Ontario, 캐나다
- Hospital for Sick Children
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, 캐나다
- Royal University Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Birth weight <1000 gm
- Gestational age <30 completed weeks
Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either:
- the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support;
- the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
Exclusion Criteria:
- Considered non-viable by clinician (decision not to administer effective therapies)
- Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- Infants known to require surgical treatment
- Abnormalities of the upper and lower airways
- Neuromuscular disorders
- Infants who are >28 days old and continue to require mechanical ventilation with an endotracheal tube
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: A
Non-invasive respiratory support via nasal intermittent positive pressure ventilation
|
Deliver non-invasive respiratory support via ventilator with NIPPV device
|
|
활성 비교기: B
Non-invasive respiratory support via nasal Continuous Positive Airway Pressure
|
Deliver non-invasive respiratory support via ventilator with nCPAP device
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia
기간: 36 weeks gestational age
|
36 weeks gestational age
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
임신 36주에 모든 원인 사망
기간: 재태 연령 36주
|
재태 연령 36주
|
|
미숙아 망막병증
기간: 퇴원하다
|
퇴원하다
|
|
All cause mortality before first discharge home
기간: first discharge home
|
first discharge home
|
|
ultrasonographic evidence of brain injury
기간: 36 weeks gestional age
|
36 weeks gestional age
|
|
necrotizing enterocolitis
기간: 36 weeks gestational age
|
36 weeks gestational age
|
|
growth
기간: discharge home
|
discharge home
|
|
time to establish full feeds
기간: discharge home
|
discharge home
|
|
nosocomial infections
기간: discharge home
|
discharge home
|
|
need for re-intubation
기간: 36 weeks gestational age
|
36 weeks gestational age
|
|
time on supplemental oxygen
기간: discharge home
|
discharge home
|
|
duration of positive pressure respiratory support
기간: discharge home
|
discharge home
|
|
comparison of synchronized and non-synchronized NIPPV
기간: discharge home
|
discharge home
|
|
bronchopulmonary dysplasia
기간: 36 weeks gestational age
|
36 weeks gestational age
|
|
air leak syndromes
기간: 36 weeks gestational age
|
36 weeks gestational age
|
|
nasal trauma
기간: discharge home
|
discharge home
|
공동 작업자 및 조사자
수사관
- 연구 의자: Haresh Kirpalani, MD, MSc, Hamilton Health Sciences Corporation
- 연구 책임자: Brigitte Lemyre, MD, Children'S Hospital Of Eastern Ontario
- 연구 책임자: Aaron Chiu, MD, St. Boniface Hospital
- 연구 책임자: David Millar, MD, Royal Maternity Hospital, Belfast
- 연구 책임자: Robin S Roberts, MTech, Hamilton Health Sciences/McMaster University
- 연구 책임자: Bradley Yoder, MD, University of Utah
- 연구 책임자: Peter H Dijk, MD, PhD, University Medical Centrum Groningen
간행물 및 유용한 링크
일반 간행물
- Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug 15;369(7):611-20. doi: 10.1056/NEJMoa1214533.
- Bamat NA, Guevara JP, Bryan M, Roberts RS, Yoder BA, Lemyre B, Chiu A, Millar D, Kirpalani H. Variation in Positive End-Expiratory Pressure Levels for Mechanically Ventilated Extremely Low Birth Weight Infants. J Pediatr. 2018 Mar;194:28-33.e5. doi: 10.1016/j.jpeds.2017.10.065. Epub 2017 Dec 22.
- Millar D, Lemyre B, Kirpalani H, Chiu A, Yoder BA, Roberts RS. A comparison of bilevel and ventilator-delivered non-invasive respiratory support. Arch Dis Child Fetal Neonatal Ed. 2016 Jan;101(1):F21-5. doi: 10.1136/archdischild-2014-308123. Epub 2015 Jul 10.
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 (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. .