Clinical trial NCT05446272: The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
Official title: The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Extubation Failure
Bronchopulmonary Dysplasia
Death
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-07-06
Enrollment: 478
Sex: ALL
Minimum age (years): 0
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Extubation failure
timeFrame: within the first 5 days (120 hours) post extubation
Secondary outcomes:
measure: Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA
timeFrame: 36 weeks PMA
measure: Death or BPD at 36 weeks PMA
timeFrame: 36 weeks PMA
measure: Endotracheal intubation through 36 weeks PMA
timeFrame: 36 weeks PMA
measure: Postmenstrual age at last invasive ventilation
timeFrame: 36 weeks PMA
measure: Postmenstrual age at last positive pressure support
timeFrame: 36 weeks PMA
measure: Postmenstrual age at last supplemental oxygen
timeFrame: 36 weeks PMA
measure: Prematurity-related morbidities through 36 weeks PMA
timeFrame: 36 weeks PMA
Other outcomes:
measure: Death
timeFrame: From randomization through 36 weeks PMA
measure: Air Leaks
timeFrame: From randomization through 36 weeks PMA
measure: Gastrointestinal perforation or bleeding
timeFrame: From randomization through 36 weeks PMA
measure: Regional distribution of lung aeration
timeFrame: From extubation through 5 days after extubation
measure: Mean airway pressure
timeFrame: From extubation through 5 days after extubation
measure: peak inflation pressure
timeFrame: From extubation through 5 days after extubation
measure: Edi signal
timeFrame: From extubation through 5 days after extubation
measure: Fio2
timeFrame: From extubation through 5 days after extubation
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: San Diego
country: United States
facility: Sharp Mary Birch
state: California
city: Hollywood
country: United States
facility: Joe DiMaggio Children's Hospital
state: Florida
city: Orlando
country: United States
facility: AdventHealth
state: Florida
city: Indianapolis
country: United States
facility: Peyton Manning Children's Hospital
state: Indiana
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St.Louis
state: Missouri
city: Voorhees
country: United States
facility: Virtua Vorhees Hospital
state: New Jersey
city: Charlotte
country: United States
facility: Levine Children's Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrial Health Brenner Children's Hospital( Wake Forest)
state: North Carolina
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Richmond
country: United States
facility: Children's Hospital of Richmond
state: Virginia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mt Sinai Hospital
city: Vancouver
country: Canada
facility: BC Children's and Women's Hospital
Study officials:
affiliation: CHOP/UPENN
name: Elizabeth Foglia
role: PRINCIPAL_INVESTIGATOR
References: