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

NCT06786039 | Recruiting DMC

• 1 other identifier: 2024AN0554
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm Infant

Keywords

infant, premature; Noninvasive NAVA

Outcome Measures

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)

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

Secondary Outcomes (17)

• Rate of bronchopulmonary dysplasia (BPD)

  at 36 weeks of postmenstrual age

• Duration of non-invasive ventilation

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

• Incidence of periventricular leukomalacia (PVL)

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

• Duration of invasive ventilation

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

• Incidence of air leaks

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

Study Arms (1)

NIV-NAVA application

Preterm infants born between 27 weeks 0 days to 31 weeks 6 days of gestation requiring respiratory support within 48 hours after birth

Procedure: Non-invasive NAVA

Interventions

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.

NIV-NAVA application

Eligibility Criteria

• Age: 1 Hour - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (2)

Seoul National Bundang Hospital NICU

Seongnam-si, Gyeonggi-do, 13620, South Korea

NOT YET RECRUITING

Korea University Anam Hospital, NICU

Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Juyoung Lee, Professor

CONTACT

+82-2-920-5647; juyounglee@korea.ac.kr

Hannah Cho, Professor

CONTACT

hannahv2@korea.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 22, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 20, 2029
• Study Completion (Estimated): December 20, 2030
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

KR (2)