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849912

The diaphragmatic initiated ventilatory assist (diva) trial
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05446272
Recrutement partiellement ouvert
Dernière modification : 2024/09/18
Type de recherche

Interventionnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Gestational age of 23 0/7- 28 6/7 weeks at birth
* Intubated in the first 7 days of life
* Undergoing extubation following at least 12 hours of invasive mechanical ventilation
* Post-natal age \<32 weeks Post menstrual age at time of extubation

Exclusion Criteria:

* Major congenital anomalies, including pulmonary hypoplasia
* Neurologic disorders affecting respiratory drive (other than apnea of prematurity)
* Esophageal bleeding or other contraindication to NG/OG catheter placement
* Current weight \<500 grams (based on Edi catheter approval)
* Study ventilator not available at time eligibility criteria are met
* Planned surgery or invasive procedure within 5 days of extubation
* Informed consent not provided

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
NIV-NAVA Donnée non disponible Donnée non disponible
  • Inconnu
  • NS- NIPPV Donnée non disponible Donnée non disponible
  • Inconnu
  • NIV-NAVA
    État du recrutement
    unknown
    NS- NIPPV
    État du recrutement
    unknown
    Données à jour depuis : 18 septembre 2024

    Description de l'étude

    Résumé de l'étude

    DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 23 0/7-28 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) (C) compared with Non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), will reduce the incidence of (O) extubation failure within (T) 5 days (120 hours) of extubation.

    Source : Importé depuis le centre

    Bronchopulmonary dysplasia (BPD) is the most common complication of prematurity and is the leading respiratory cause of childhood morbidity. Ventilator induced lung injury (VILI) an accepted and important contributor to BPD. Exposure to oxygen and positive pressure ventilation leads to developmental arrest and parenchymal injury in the immature preterm lung. Because even brief exposure to intubated positive pressure ventilation is injurious, avoiding invasive mechanical ventilation is the most widely acknowledged strategy to prevent VILI and the long-term sequela of BPD. Therefore, time on ventilators and rates of successful extubation are important endpoints of therapy.

    Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is an FDA approved technology that consistently synchronizes non-invasive respiratory support with infant respiratory drive. The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial is an unblinded, pragmatic, multicenter phase III randomized clinical trial in extremely preterm infants 23 0/7- 28 6/7 weeks gestational age to determine if NIV-NAVA, compared with non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), prevents extubation failure within 5 days (120 hours) of extubation from mechanical ventilation

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 18 septembre 2024
    Données à jour depuis : 30 déc.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT05446272