The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

Launched by UNIVERSITY OF PENNSYLVANIA · Jun 28, 2022

Keywords

ClinConnect Summary

The DIVA Trial is a study looking at how to help very premature babies (born between 23 and 28 weeks gestation) who need to be taken off a breathing machine, a process called extubation. The trial compares two types of breathing support: one that uses a special method called Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) and another called Non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV). The goal is to see if using NIV-NAVA can lower the chances of these babies needing to go back on a breathing machine within five days after being taken off it.

To participate in this study, babies must be between 23 and 28 weeks gestation, have been on a breathing machine in their first week of life, and be less than 32 weeks old at the time they are taken off the machine. However, babies with major health issues or certain medical conditions will not be eligible. If enrolled, families can expect close monitoring and support as the baby transitions from the breathing machine, helping to ensure the best possible care during this critical time.

Gender

ALL

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