Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
20. april 2016 opdateret af: Yuan Shi, Third Military Medical University
The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy. Nevertheless, NIPPV has never been used in chinese babies.
The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Chongqing
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Chongqing, Chongqing, Kina, 400042
- Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
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-
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
1 minut til 4 uger (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Newborn infants with birth weight >500 gm.
- Gestational age >24 completed weeks.
- Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: 1) 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; 2)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.
- No known lethal congenital anomaly or genetic syndromes.
- Signed parental informed consent.
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: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: NIPPV
The NIPPV group receiving NIPPV treatment.
|
Ventilator is Bird VIP.
Ventilator(Bird VIP) is used for NIPPV device.
Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group.
The duration of NIPPV is according to the baby's respiratory condition.
|
|
Aktiv komparator: Control
The Control group receiving nCPAP treatment.
|
Ventilator is Bird VIP.
Ventilator(Bird VIP) is used for NIPPV device.
Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group.
The duration of NIPPV is according to the baby's respiratory condition.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.
Tidsramme: At 7 days after non-invasive respiratorynsupport.
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At 7 days after non-invasive respiratorynsupport.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age.
Tidsramme: At 7 days, 28 days and at 36 weeks postmenstraul age
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At 7 days, 28 days and at 36 weeks postmenstraul age
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Yuan Shi, MD, Department of Pediatrics, Daping Hospital, Third Military Medical University
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.
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. januar 2008
Primær færdiggørelse (Faktiske)
1. december 2011
Studieafslutning (Faktiske)
1. december 2012
Datoer for studieregistrering
Først indsendt
24. oktober 2008
Først indsendt, der opfyldte QC-kriterier
24. oktober 2008
Først opslået (Skøn)
27. oktober 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NCR2008053
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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