Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
ConditionPreterm Infant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-48
SponsorKorea University Anam Hospital
About this trial
This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm infants born between 27 weeks 0 days to 31 weeks 6 days of gestation
Preterm infants who require respiratory support within the first 48 hours of life
Disqualifiers
Preterm infants who die within the first 48 hours of life
Preterm infants who do not require any respiratory support within the first 48 hours of life.
Preterm infants with congenital anomalies affecting the lungs, heart, or other organs that could influence breathing
Infants whose parents do not consent to participate in the study
Trial population
Patients admitted to the NICU in Korea University Anam Hospital will be recruited over a 2-year period.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-invasive NAVA
Procedure/SurgeryInitiate respiratory assist with NIV-NAVA within 48 hours. The setting of respiratory support will be adjusted based on clinical conditions of each subject. NIV-NAVA could be switched to nasal continuous airway pressure or high flow nasal cannula, and it also could be stopped after initial stabilization. In cases of respiratory distress syndrome, lung surfactant will be administered via the less invasive surfactant administration (LISA) method and avoid endotracheal intubation whenever possible. For who intubated in the delivery room, extubation with NIV-NAVA should be considered as soon as possible. Endotracheal intubation with invasive ventilation could be applied when clinical deteriorations happens.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: NIV-NAVA application1 intervention
Trial outcomes
Primary outcomes
1
Rate of Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) failure
NIV-NAVA failure was defined as a participant requiring endotracheal intubation (except brief intubation for only surfactant administration)
Time frame
through the study completion, during the hospital stay in neonatal intensive care unit up to 3 monthsSecondary outcomes
1
Rate of bronchopulmonary dysplasia (BPD)
diagnosed according to the Jensen Criteria
Time frame
at 36 weeks of postmenstrual age2
Duration of non-invasive ventilation
each of NIV-NAVA, nasal continuous positive airway pressure, high flow nasal cannula
Time frame
through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months3
Incidence of periventricular leukomalacia (PVL)
diagnosed by brain ultrasound or MRI
Time frame
through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months4
Duration of invasive ventilation
each of high-frequent oscillatory ventilation, conventional mechanical ventilation, NAVA etc
Time frame
through the study completion, during the hospital stay in neonatal intensive care unit up to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov