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Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP

14 september 2015 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19107
        • Pennsylvania Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 timmar till 3 dagar (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: HHHFNC

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

Escalation of the ventilatory support per protocol and the attending physician.

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.
Övrig: NCPAP

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

Escalation of the ventilatory support per protocol and the attending physician.

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pulmonary mechanics and chest wall asynchrony measures.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Duration of respiratory support or oxygen use up to the time of discharge from the NICU.
Tidsram: 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.
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Utredare

  • Huvudutredare: Soraya Abbasi, MD, University of Pennsylvania

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2014

Primärt slutförande (Faktisk)

1 mars 2014

Avslutad studie (Faktisk)

1 mars 2014

Studieregistreringsdatum

Först inskickad

30 augusti 2013

Först inskickad som uppfyllde QC-kriterierna

9 september 2013

Första postat (Uppskatta)

11 september 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

15 september 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 september 2015

Senast verifierad

1 september 2015

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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