Clinical trial NCT06786039: Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
Official title: Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm Infant
Keywords: infant, premature
Noninvasive NAVA
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the NICU in Korea University Anam Hospital will be recruited over a 2-year period.

Brief summary: 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: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) failure
timeFrame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Secondary outcomes:
measure: Rate of bronchopulmonary dysplasia (BPD)
timeFrame: at 36 weeks of postmenstrual age
measure: Duration of non-invasive ventilation
timeFrame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
measure: Incidence of periventricular leukomalacia (PVL)
timeFrame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
measure: Duration of invasive ventilation
timeFrame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
measure: Incidence of air leaks
timeFrame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
measure: Incidence of patent ductus arteriosus (PDA)
timeFrame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
measure: Time to achieve full enteral feeding
timeFrame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
measure: Incidence of intraventricular hemorrhage (IVH)
timeFrame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
measure: Incidence of retinopathy of prematurity (ROP)
timeFrame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
measure: Total brain volume (mL)
timeFrame: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI
measure: Intracranial volume (mL)
timeFrame: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI
measure: Relative sizes of volumes of particular regions of interest
timeFrame: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI
measure: Bayley Scales of Infant Development III - 2 yr
timeFrame: 18-24 months of corrected age
measure: Modified Checklist for Autism in Toddlers (M-CHAT)
timeFrame: 18-24 months of corrected age
measure: MacArthur-Bates Communication Development Inventory
timeFrame: 18-24 months of corrected age
measure: Bayley Scales of Infant Development III - 3 yr
timeFrame: 33-39 months of age
measure: Child Behavior Checklist (CBCL)
timeFrame: 33-39 months of age
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Bundang Hospital NICU
state: Kyungki-do
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital, NICU
Study officials:
References: