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Recruiting NCT06786039

Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants

— Observational Preterm Infant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-invasive NAVA.
Who it may be relevant to
Registry conditions: Preterm Infant. Basic parameters: 1 Hour — 48 Hours · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Non-invasive NAVA
    Initiate 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

Primary outcome measures

  • Rate of Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) failure [Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
Secondary outcome measures (12)
  • Rate of bronchopulmonary dysplasia (BPD) [Time frame: at 36 weeks of postmenstrual age]
  • Duration of non-invasive ventilation [Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Incidence of periventricular leukomalacia (PVL) [Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Duration of invasive ventilation [Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Incidence of air leaks [Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Incidence of patent ductus arteriosus (PDA) [Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Time to achieve full enteral feeding [Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Incidence of intraventricular hemorrhage (IVH) [Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Incidence of retinopathy of prematurity (ROP) [Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Total brain volume (mL) [Time frame: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI]
  • Intracranial volume (mL) [Time frame: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI]
  • Relative sizes of volumes of particular regions of interest [Time frame: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 2 centers
  • Seoul National Bundang Hospital NICU — Seongnam-si
  • Korea University Anam Hospital, NICU — Seoul

Publications

  • Cho H, Jung YH, Park J, Yang HJ, Kim MJ, Lee J. Feasibility of NIV-NAVA as a primary respiratory support and its clinical impacts in a targeted group of preterm infants: protocol for a prospective observational study. BMJ Open. 2026 Jun 7;16(6):e114353. doi: 10.1136/bmjopen-2025-114353. PMID 42252137

Identifiers

NCT: NCT06786039 · 2024AN0554

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗