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NCT Number: NCT06786039

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

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.

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Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 hour–48 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National Bundang Hospital NICU, Seongnam-si, Gyeonggi-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive NAVA

Procedure

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. 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.

Primary outcomes

  1. 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

    NIV-NAVA failure was defined as a participant requiring endotracheal intubation (except brief intubation for only surfactant administration)

Secondary outcomes

  1. Rate of bronchopulmonary dysplasia (BPD)

    Time frame: at 36 weeks of postmenstrual age

    diagnosed according to the Jensen Criteria

  2. Duration of non-invasive ventilation

    Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months

    each of NIV-NAVA, nasal continuous positive airway pressure, high flow nasal cannula

  3. Incidence of periventricular leukomalacia (PVL)

    Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months

    diagnosed by brain ultrasound or MRI

  4. Duration of invasive ventilation

    Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months

    each of high-frequent oscillatory ventilation, conventional mechanical ventilation, NAVA etc

  5. Incidence of air leaks

    Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months

    including pneumothorax, pneumomediastinum and pulmonary interstitial emphysema

  6. 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

    defined by clinical and/or echocardiographic criteria requiring symptomatic treatment (except prophylaxis)

  7. 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

    day of life when milk amount reaches 100 mL/kg/day or higher

  8. Incidence of intraventricular hemorrhage (IVH)

    Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months

    defined by the Papile criteria, using cranial ultrasonography (≥grade 2)

  9. 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

    defined according to the international classification of ROP (≥stage 2)

  10. Total brain volume (mL)

    Time frame: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI

    Total brain volume (TBV) will be measured from Brain MRI

  11. Intracranial volume (mL)

    Time frame: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI

    Intracranial volume (ICV) will be measured from Brain MRI

  12. 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

    relative sizes of volumes of particular regions of interest (ROIs) will be measured from brain MRI

  13. Bayley Scales of Infant Development III - 2 yr

    Time frame: 18-24 months of corrected age

    scale scores for each development areas (cognitive, language, motor) score range : 0-200 above average (1-2 SD, score 116-130) average ( 1 to 1 SD, score 85-115) below average (1 to-2 SD, score 84-70) well below average (<-2 SD, scores < 70).

  14. Modified Checklist for Autism in Toddlers (M-CHAT)

    Time frame: 18-24 months of corrected age

    autism spectrum disorder screening test result total score 0-2: low risk total score 3-7: moderate risk total score 8-20: high risk

  15. MacArthur-Bates Communication Development Inventory

    Time frame: 18-24 months of corrected age

    language evaluation questionnaire result The criterion for identifying risk for delayed language development was an expressive vocabulary size <10th percentile

  16. Bayley Scales of Infant Development III - 3 yr

    Time frame: 33-39 months of age

    scale scores for each development areas (cognitive, language, motor) score range : 0-200 above average (1-2 SD, score 116-130) average ( 1 to 1 SD, score 85-115) below average (1 to-2 SD, score 84-70) well below average (<-2 SD, scores < 70).

  17. Child Behavior Checklist (CBCL)

    Time frame: 33-39 months of age

    behavior screening questionnaire result t-score ≤ 59: non-clinical symptoms, t-score between 60 and 64: at risk for problem behaviors t-score ≥ 65: clinical symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Cho, Professor

CONTACT

[email protected]

Juyoung Lee, Professor

CONTACT

[email protected]

+82-2-920-5647

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jan 22, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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