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?
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Groningen, Alankomaat, 9700 RB
- University Medical Center Groningen/Beatrix Children's Hosp
-
Zwolle, Alankomaat, 8000 GK
- Princess Amalia Dept of Pediatrics, Isala Clinics
-
-
-
-
-
Rocourt, Belgia, B-4000
- CHC St. Vincent
-
-
-
-
-
Dublin, Irlanti
- National Maternity Hospital
-
Dublin, Irlanti
- Coombe Women's Hospital
-
-
Cork
-
Wilton, Cork, Irlanti
- Cork University Maternity Hospital
-
-
-
-
-
Feldkirch, Itävalta, 6800
- LKH Feldkirch
-
-
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada
- Winnipeg Health Sciences Centre
-
Winnipeg, Manitoba, Kanada, R3E 0L8
- St. Boniface General Hospital/University of Manitoba
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada
- IWK Health Centre
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8S 4J9
- McMaster University
-
Ottawa, Ontario, Kanada, K1H 8L1
- Children's Hospital of Eastern Ontario
-
Ottawa, Ontario, Kanada, K1H 8L6
- The Ottawa Hospital General Campus
-
Toronto, Ontario, Kanada
- Hospital for Sick Children
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Kanada
- Royal University Hospital
-
-
-
-
-
Doha, Qatar
- Hamad Medical Corporation
-
-
-
-
-
Stockholm, Ruotsi, S-171 76
- Karolinska University Hospital/Astrid Lingrenn's Children's Hospital
-
-
-
-
-
Singapore, Singapore, 229899
- KK Women's and Children's Hospital
-
-
-
-
-
Leicester, Yhdistynyt kuningaskunta, LE1 6TP
- University of Leicester
-
London, Yhdistynyt kuningaskunta, W2 1NY
- St. Mary's Hospital
-
-
Northern Ireland
-
Belfast, Northern Ireland, Yhdistynyt kuningaskunta, BT12 6BB
- Royal Maternity Hospital
-
-
-
-
District of Columbia
-
Washington, District of Columbia, Yhdysvallat, 20037
- The George Washington University Hospital
-
Washington, District of Columbia, Yhdysvallat, 20007
- Georgetown University Children's Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Yhdysvallat, 02215
- Beth Israel Deaconess Medical Center (BIDMC)
-
Boston, Massachusetts, Yhdysvallat, 02111
- Tufts University Medical Center
-
-
New Jersey
-
Voorhees, New Jersey, Yhdysvallat, 08043
- Virtua West Jersey Hospital
-
-
New York
-
Brooklyn, New York, Yhdysvallat, 11203
- Kings County Hospital
-
Brooklyn, New York, Yhdysvallat, 11023
- SUNY Downstate Medical Center
-
Brooklyn, New York, Yhdysvallat, 11355
- New York Hospital Queens
-
Jamaica, New York, Yhdysvallat, 11432
- Queens Hospital Center
-
New York, New York, Yhdysvallat, 11212
- Brookdale University Hospital & Medical Center
-
Stony Brook, New York, Yhdysvallat, 11794-8111
- Stony Brook University Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Yhdysvallat, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Yhdysvallat, 19035
- Pennsylvania Hospital/U. of Pennsylvania
-
-
Utah
-
Salt Lake City, Utah, Yhdysvallat, 84158-1289
- University of Utah
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: A
Non-invasive respiratory support via nasal intermittent positive pressure ventilation
|
Deliver non-invasive respiratory support via ventilator with NIPPV device
|
|
Active Comparator: B
Non-invasive respiratory support via nasal Continuous Positive Airway Pressure
|
Deliver non-invasive respiratory support via ventilator with nCPAP device
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia
Aikaikkuna: 36 weeks gestational age
|
36 weeks gestational age
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Kaikki aiheuttavat kuolleisuutta raskausviikolla 36
Aikaikkuna: Raskausviikko 36
|
Raskausviikko 36
|
|
keskosten retinopatia
Aikaikkuna: purkaminen kotiin
|
purkaminen kotiin
|
|
All cause mortality before first discharge home
Aikaikkuna: first discharge home
|
first discharge home
|
|
ultrasonographic evidence of brain injury
Aikaikkuna: 36 weeks gestional age
|
36 weeks gestional age
|
|
necrotizing enterocolitis
Aikaikkuna: 36 weeks gestational age
|
36 weeks gestational age
|
|
growth
Aikaikkuna: discharge home
|
discharge home
|
|
time to establish full feeds
Aikaikkuna: discharge home
|
discharge home
|
|
nosocomial infections
Aikaikkuna: discharge home
|
discharge home
|
|
need for re-intubation
Aikaikkuna: 36 weeks gestational age
|
36 weeks gestational age
|
|
time on supplemental oxygen
Aikaikkuna: discharge home
|
discharge home
|
|
duration of positive pressure respiratory support
Aikaikkuna: discharge home
|
discharge home
|
|
comparison of synchronized and non-synchronized NIPPV
Aikaikkuna: discharge home
|
discharge home
|
|
bronchopulmonary dysplasia
Aikaikkuna: 36 weeks gestational age
|
36 weeks gestational age
|
|
air leak syndromes
Aikaikkuna: 36 weeks gestational age
|
36 weeks gestational age
|
|
nasal trauma
Aikaikkuna: discharge home
|
discharge home
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojen puheenjohtaja: Haresh Kirpalani, MD, MSc, Hamilton Health Sciences Corporation
- Opintojohtaja: Brigitte Lemyre, MD, Children's Hospital of Eastern Ontario
- Opintojohtaja: Aaron Chiu, MD, St. Boniface Hospital
- Opintojohtaja: David Millar, MD, Royal Maternity Hospital, Belfast
- Opintojohtaja: Robin S Roberts, MTech, Hamilton Health Sciences/McMaster University
- Opintojohtaja: Bradley Yoder, MD, University of Utah
- Opintojohtaja: Peter H Dijk, MD, PhD, University Medical Centrum Groningen
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Hengityselinten sairaudet
- Hengityshäiriöt
- Keuhkosairaudet
- Vauva, vastasyntynyt, sairaudet
- Raskauden komplikaatiot
- Synnytystyön komplikaatiot
- Synnytystyö, ennenaikainen
- Keuhkovaurio
- Vauva, Keskoset, Sairaudet
- Hengityslaitteen aiheuttama keuhkovaurio
- Hengityksen vajaatoiminta
- Ennenaikainen Synnytys
- Bronkopulmonaalinen dysplasia
Muut tutkimustunnusnumerot
- NTG-2007-NIPPV
- CIHR MCT-80246
- ISRCTN15233270
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .