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Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP

14. september 2015 opdateret af: Children's Hospital of Philadelphia

Pulmonary Mechanics in Preterm Infants Treated With Heated Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure.

This study is designed to evaluate the effect of heated humidified high flow nasal cannula (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Respiratory distress and the need for respiratory support continues to be a common problem for preterm infants. Presence of the breathing tube and duration of respirator provided breaths have been shown to be associated with increased risk for secondary lung injury and subsequent development of chronic lung disease of prematurity. Early application of noninvasive nasal continuous positive airway pressure (NCPAP) has been shown to be an effective, non-invasive, mode of respiratory support in preterm infants and to be associated with a lower incidence of chronic lung disease. A recently published large randomized multicenter study concluded that, among infants born at 28 weeks and longer gestation, heated humidified high flow nasal cannula (HHHFNC) had similar clinical efficacy and safety as compared to NCPAP. Both NCPAP and HHHFNC are currently used to assist infants with breathing problems.

This study is designed to evaluate the effect of HHHFNC as compared to NCPAP on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support. In this study, infants will remain on the assigned treatment of either NCPAP or HHHFNC until they require more support as provided by a respirator or until a treatment cross-over from NCPAP to HHHFNC, or the reverse, as decided by their attending physician. The infant's respiratory support will be managed according to his/her attending doctor as per accepted standards of care. A pulmonary function test will be performed twice weekly on each enrolled infant while receiving either NCPAP or HHHFNC support, followed-up by once weekly lung function measurements post respiratory support while infants are breathing only room air until discharge.

Undersøgelsestype

Interventionel

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Pennsylvania Hospital

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

2 timer til 3 dage (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Birth weight greater than or equal to 1000 grams.
  2. Gestational age at birth between 28 weeks and 37 weeks (28 0/7 to 37 6/7 weeks inclusive).

  3. Candidate for non-invasive respiratory support as a result of:

    1. An intention to manage the infant with non-invasive (no endotracheal tube) respiratory support.
    2. An intention to extubate an infant being managed with intubated respiratory support to non-invasive respiratory support.
  4. Subjects must have a guardian or acceptable surrogate capable of giving consent on his/her behalf.

Exclusion Criteria:

  1. Birth weight less than 1000 grams.
  2. Estimated gestation at birth less than 28 weeks or greater than 37 6/7 weeks.
  3. Active air leak syndrome.
  4. Subjects will not be eligible if they are not considered viable.
  5. Infants with abnormalities of the upper and lower airways
  6. Infants with significant abdominal or respiratory malformations .

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: HHHFNC

Treatment of respiratory distress by Heated Humidified High Flow Nasal Cannula (HHHFNC).

Escalation of the ventilatory support per protocol and the attending physician.
Enhed: Heated Humidified High Flow Nasal Cannula
Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on HHHFNC and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies.
Andet: NCPAP

Treatment of respiratory distress by nasal continuous positive airway pressure (NCPAP).

Escalation of the ventilatory support per protocol and the attending physician.
Enhed: Nasal Continuous Positive Airway Pressure
Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on NCPAP and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pulmonary mechanics and chest wall asynchrony measures.
Tidsramme: 2 years
Pulmonary mechanics measures consisting of dynamic lung compliance, airway resistance, and work of breathing and chest wall asynchrony measures consisting of thoracoabdominal asynchrony, labored breathing index and rib cage to abdominal phase relation during the total breath are measured in preterm infants treated with HHHFNC and compared to the same measurements in preterm infants treated with NCPAP.
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of respiratory support or oxygen use up to the time of discharge from the NICU.
Tidsramme: 2 years
The total number of days while infants are on any type of respiratory support or oxygen use prior to discharge in preterm infants treated with HHHFNC compared to NCPAP during their hospital stay.
2 years
The incidence of potential adverse outcomes associated with HHHFNC or NCPAP.
Tidsramme: 2 years
The number and percentage of infants in each group with adverse effects such as facial and upper airways injury associated with the use of HHHFNC or NCPAP.
2 years
Time needed to establish full enteral feeds
Tidsramme: 2 years
The total number of days needed to establish full enteral feeds in preterm infants treated with HHHFNC as compared to preterm infants treated with NCPAP.
2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Children's Hospital of Philadelphia

Efterforskere

  • Ledende efterforsker: Soraya Abbasi, MD, University of Pennsylvania

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. marts 2014

Primær færdiggørelse (Faktiske)

1. marts 2014

Studieafslutning (Faktiske)

1. marts 2014

Datoer for studieregistrering

Først indsendt

30. august 2013

Først indsendt, der opfyldte QC-kriterier

9. september 2013

Først opslået (Skøn)

11. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12-009882

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 .

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Kliniske forsøg med Heated Humidified High Flow Nasal Cannula

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