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?
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Rocourt, Belgia, B-4000
- CHC St. Vincent
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Manitoba
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Winnipeg, Manitoba, Canada
- Winnipeg Health Sciences Centre
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Winnipeg, Manitoba, Canada, R3E 0L8
- St. Boniface General Hospital/University of Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canada
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8S 4J9
- McMaster University
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital General Campus
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Toronto, Ontario, Canada
- Hospital for Sick Children
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- Royal University Hospital
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District of Columbia
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Washington, District of Columbia, Forente stater, 20037
- The George Washington University Hospital
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Washington, District of Columbia, Forente stater, 20007
- Georgetown University Children's Medical Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Beth Israel Deaconess Medical Center (Bidmc)
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Boston, Massachusetts, Forente stater, 02111
- Tufts University Medical Center
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New Jersey
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Voorhees, New Jersey, Forente stater, 08043
- Virtua West Jersey Hospital
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New York
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Brooklyn, New York, Forente stater, 11203
- Kings County Hospital
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Brooklyn, New York, Forente stater, 11023
- SUNY Downstate Medical Center
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Brooklyn, New York, Forente stater, 11355
- New York Hospital Queens
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Jamaica, New York, Forente stater, 11432
- Queens Hospital Center
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New York, New York, Forente stater, 11212
- Brookdale University Hospital & Medical Center
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Stony Brook, New York, Forente stater, 11794-8111
- Stony Brook University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Forente stater, 19035
- Pennsylvania Hospital/U. of Pennsylvania
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Utah
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Salt Lake City, Utah, Forente stater, 84158-1289
- University of Utah
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Dublin, Irland
- National Maternity Hospital
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Dublin, Irland
- Coombe Women's Hospital
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Cork
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Wilton, Cork, Irland
- Cork University Maternity Hospital
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Groningen, Nederland, 9700 RB
- University Medical Center Groningen/Beatrix Children's Hosp
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Zwolle, Nederland, 8000 GK
- Princess Amalia Dept of Pediatrics, Isala Clinics
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Doha, Qatar
- Hamad Medical Corporation
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Singapore, Singapore, 229899
- KK Women's and Children's Hospital
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Leicester, Storbritannia, LE1 6TP
- University of Leicester
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London, Storbritannia, W2 1NY
- St. Mary's Hospital
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Northern Ireland
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Belfast, Northern Ireland, Storbritannia, BT12 6BB
- Royal Maternity Hospital
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Stockholm, Sverige, S-171 76
- Karolinska University Hospital/Astrid Lingrenn's Children's Hospital
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Feldkirch, Østerrike, 6800
- LKH Feldkirch
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: A
Non-invasive respiratory support via nasal intermittent positive pressure ventilation
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Deliver non-invasive respiratory support via ventilator with NIPPV device
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Aktiv komparator: B
Non-invasive respiratory support via nasal Continuous Positive Airway Pressure
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Deliver non-invasive respiratory support via ventilator with nCPAP device
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia
Tidsramme: 36 weeks gestational age
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36 weeks gestational age
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Alle forårsaker dødelighet ved 36 ukers svangerskapsalder
Tidsramme: 36 ukers svangerskapsalder
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36 ukers svangerskapsalder
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retinopati av prematuritet
Tidsramme: slippe hjem
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slippe hjem
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All cause mortality before first discharge home
Tidsramme: first discharge home
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first discharge home
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ultrasonographic evidence of brain injury
Tidsramme: 36 weeks gestional age
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36 weeks gestional age
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necrotizing enterocolitis
Tidsramme: 36 weeks gestational age
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36 weeks gestational age
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growth
Tidsramme: discharge home
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discharge home
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time to establish full feeds
Tidsramme: discharge home
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discharge home
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nosocomial infections
Tidsramme: discharge home
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discharge home
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need for re-intubation
Tidsramme: 36 weeks gestational age
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36 weeks gestational age
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time on supplemental oxygen
Tidsramme: discharge home
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discharge home
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duration of positive pressure respiratory support
Tidsramme: discharge home
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discharge home
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comparison of synchronized and non-synchronized NIPPV
Tidsramme: discharge home
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discharge home
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bronchopulmonary dysplasia
Tidsramme: 36 weeks gestational age
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36 weeks gestational age
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air leak syndromes
Tidsramme: 36 weeks gestational age
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36 weeks gestational age
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nasal trauma
Tidsramme: discharge home
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discharge home
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Haresh Kirpalani, MD, MSc, Hamilton Health Sciences Corporation
- Studieleder: Brigitte Lemyre, MD, Children's Hospital of Eastern Ontario
- Studieleder: Aaron Chiu, MD, St. Boniface Hospital
- Studieleder: David Millar, MD, Royal Maternity Hospital, Belfast
- Studieleder: Robin S Roberts, MTech, Hamilton Health Sciences/McMaster University
- Studieleder: Bradley Yoder, MD, University of Utah
- Studieleder: Peter H Dijk, MD, PhD, University Medical Centrum Groningen
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Respirasjonsforstyrrelser
- Lungesykdommer
- Spedbarn, nyfødte, sykdommer
- Graviditetskomplikasjoner
- Obstetriske arbeidskomplikasjoner
- Obstetrisk arbeid, prematur
- Lungeskade
- Spedbarn, premature, sykdommer
- Ventilator-indusert lungeskade
- Respiratorisk insuffisiens
- For tidlig fødsel
- Bronkopulmonal dysplasi
Andre studie-ID-numre
- NTG-2007-NIPPV
- CIHR MCT-80246
- ISRCTN15233270
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