The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

University of Pennsylvania

Status

Enrolling

Conditions

Death

Bronchopulmonary Dysplasia

Extubation Failure

Treatments

Device: NS-NIPPV

Device: NIV-NAVA

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05446272

849912

Details and patient eligibility

About

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.

Full 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

Enrollment

478 estimated patients

Sex

All

Ages

Under 9 weeks old

Volunteers

No Healthy Volunteers

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