Non-invasive Ventilation in Preterm Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 136
- Locations
- 2
- Primary Endpoint
- Total duration of respiratory support
Study Overview
Brief Summary
This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional. For all participants prospective data collection will be conducted by chart review and by downloading ventilatory data from the ventilator. A registration of respiratory severity score will be done by a caregiver during the weaning period. This consists of a visual assessment of the work of breathing every 2 hours. For participants on NIV-NAVA consenting to the interventional part of the study a titration procedure will be conducted, afterwards serial electrical impedance tomography and lung and diaphragm ultrasound measurements will be done.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm infants (< 37 weeks GA) supported with non-invasive respiratory support for at least 24 hours. Non-invasive respiratory support can consist of non-invasive NAVA, nasal continuous positive airway pressure (nCPAP) or high flow nasal canula (flow > 2 liters/min).The support can be given as primary respiratory support or as respiratory support after weaning from invasive ventilation (= after extubation).
- •Infants can only be enrolled after written and signed informed consent by the parents.
Exclusion Criteria
- •Infant born after a gestational age of 37 weeks or more.
- •Infants with major congenital malformations or chromosomal abnormalities (eg trisomy 18, congenital diaphragmatic hernia…)
Arms & Interventions
Preterm infants on non-invasive respiratory support
All infants on non-invasive respiratory support will be studied. Only infants on less than 32 weeks of gestation at birth, will undergo an intervention.
Intervention: Titration procedure (Diagnostic Test)
Preterm infants on non-invasive respiratory support
All infants on non-invasive respiratory support will be studied. Only infants on less than 32 weeks of gestation at birth, will undergo an intervention.
Intervention: Electrical impedance tomography (Diagnostic Test)
Preterm infants on non-invasive respiratory support
All infants on non-invasive respiratory support will be studied. Only infants on less than 32 weeks of gestation at birth, will undergo an intervention.
Intervention: Lung and diaphragm ultrasound (Diagnostic Test)
Outcomes
Primary Outcomes
Total duration of respiratory support
Time Frame: From birth until study completion, variating between 3 weeks and 3 months
Total number of days of invasive and non-invasive respiratory support
Rate of bronchopulmonary dysplasia (BPD) or death
Time Frame: From birth until gestational age of 36 weeks
Percentage of infants with BPD or death
Secondary Outcomes
- Duration of non-invasive respiratory support (days)(From birth until study completion, between 3 weeks and 3 months)
- Respiratory severity score (RSS)(From start of the weaning phase until respiratory support is stopped, up to 10 weeks)
- Description of mode of non-invasive respiratory support(From birth until study completion, between 3 weeks and 3 months)
- Duration of invasive respiratory support (days)(From birth until study completion, variating between 3 weeks and 3 months)
- Lung ultrasound score(At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks)
- Use of surfactant and mode of administration(From birth until study completion, between 3 weeks and 3 months)
- Use of corticosteroids for the prevention or treatment of BPD(From birth until study completion, between 3 weeks and 3 months)
- Length of hospital stay(From birth until study completion, between 3 weeks and 3 months)
- Incidence of nosocomial infection(From birth until study completion, between 3 weeks and 3 months)
- NIV-NAVA breakpoint(At inclusion (within 24 hours))
- Diaphragm ultrasound(At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks)
- Silent Spaces(At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks)
- Tidal volume (TV)(At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks)
- Center of Ventilation (CoV)(At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks)