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Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV) (NIPPV)

3. december 2014 opdateret af: McMaster University

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?

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1011

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Rocourt, Belgien, B-4000
        • CHC St. Vincent
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Winnipeg Health Sciences Centre
      • Winnipeg, Manitoba, Canada, R3E 0L8
        • St. Boniface General Hospital/University of Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4J9
        • McMaster University
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital General Campus
      • Toronto, Ontario, Canada
        • Hospital for Sick Children
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Royal University Hospital
  • Det Forenede Kongerige
      • Leicester, Det Forenede Kongerige, LE1 6TP
        • University of Leicester
      • London, Det Forenede Kongerige, W2 1NY
        • St. Mary's Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, Det Forenede Kongerige, BT12 6BB
        • Royal Maternity Hospital
  • Forenede Stater
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20037
        • The George Washington University Hospital
      • Washington, District of Columbia, Forenede Stater, 20007
        • Georgetown University Children's Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center (BIDMC)
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts University Medical Center
    • New Jersey
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Virtua West Jersey Hospital
    • New York
      • Brooklyn, New York, Forenede Stater, 11203
        • Kings County Hospital
      • Brooklyn, New York, Forenede Stater, 11023
        • SUNY Downstate Medical Center
      • Brooklyn, New York, Forenede Stater, 11355
        • New York Hospital Queens
      • Jamaica, New York, Forenede Stater, 11432
        • Queens Hospital Center
      • New York, New York, Forenede Stater, 11212
        • Brookdale University Hospital & Medical Center
      • Stony Brook, New York, Forenede Stater, 11794-8111
        • Stony Brook University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19035
        • Pennsylvania Hospital/U. of Pennsylvania
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84158-1289
        • University of Utah
  • Holland
      • Groningen, Holland, 9700 RB
        • University Medical Center Groningen/Beatrix Children's Hosp
      • Zwolle, Holland, 8000 GK
        • Princess Amalia Dept of Pediatrics, Isala Clinics
  • Irland
      • Dublin, Irland
        • National Maternity Hospital
      • Dublin, Irland
        • Coombe Women's Hospital
    • Cork
      • Wilton, Cork, Irland
        • Cork University Maternity Hospital
  • Qatar
      • Doha, Qatar
        • Hamad Medical Corporation
  • Singapore
      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital
  • Sverige
      • Stockholm, Sverige, S-171 76
        • Karolinska University Hospital/Astrid Lingrenn's Children's Hospital
  • Østrig
      • Feldkirch, Østrig, 6800
        • LKH Feldkirch

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 4 uger (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: A
Non-invasive respiratory support via nasal intermittent positive pressure ventilation
Enhed: NIPPV
Deliver non-invasive respiratory support via ventilator with NIPPV device
Aktiv komparator: B
Non-invasive respiratory support via nasal Continuous Positive Airway Pressure
Enhed: nCPAP
Deliver non-invasive respiratory support via ventilator with nCPAP device

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia
Tidsramme: 36 weeks gestational age
36 weeks gestational age

Sekundære resultatmål

Resultatmål
Tidsramme
Alle forårsager dødelighed ved 36 ugers svangerskabsalder
Tidsramme: 36 ugers svangerskabsalder
36 ugers svangerskabsalder
retinopati af præmaturitet
Tidsramme: udskrive hjem
udskrive hjem
All cause mortality before first discharge home
Tidsramme: first discharge home
first discharge home
ultrasonographic evidence of brain injury
Tidsramme: 36 weeks gestional age
36 weeks gestional age
necrotizing enterocolitis
Tidsramme: 36 weeks gestational age
36 weeks gestational age
growth
Tidsramme: discharge home
discharge home
time to establish full feeds
Tidsramme: discharge home
discharge home
nosocomial infections
Tidsramme: discharge home
discharge home
need for re-intubation
Tidsramme: 36 weeks gestational age
36 weeks gestational age
time on supplemental oxygen
Tidsramme: discharge home
discharge home
duration of positive pressure respiratory support
Tidsramme: discharge home
discharge home
comparison of synchronized and non-synchronized NIPPV
Tidsramme: discharge home
discharge home
bronchopulmonary dysplasia
Tidsramme: 36 weeks gestational age
36 weeks gestational age
air leak syndromes
Tidsramme: 36 weeks gestational age
36 weeks gestational age
nasal trauma
Tidsramme: discharge home
discharge home

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

McMaster University

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)

Efterforskere

  • 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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2007

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

7. februar 2007

Først indsendt, der opfyldte QC-kriterier

8. februar 2007

Først opslået (Skøn)

9. februar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2014

Sidst verificeret

1. december 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NTG-2007-NIPPV
  • CIHR MCT-80246
  • ISRCTN15233270

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Respiratorisk insufficiens af præmaturitet

Kliniske forsøg med NIPPV

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kazakhstan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner