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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Infant
• Intervention / Treatment: Procedure: Non-invasive NAVA

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Juyoung Lee, Professor; Phone Number: +82-2-920-5647; Email: juyounglee@korea.ac.kr
• Study Contact Backup: Name: Hannah Cho, Professor; Email: hannahv2@korea.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital, NICU
    • Contact: Juyoung Lee, MD, PhD; Phone Number: +82-2-920-5647; Email: juyounglee@korea.ac.kr
    • Principal Investigator: Juyoung Lee, MD, PhD
    • Sub-Investigator: Hannah Cho, MD, PhD
  • Kyungki-do
    • Seongnam-si, Kyungki-do, Korea, Republic of, 13620
      • Not yet recruiting
      • Seoul National Bundang Hospital NICU
      • Contact: Young Hwa Jung, Professor; Phone Number: +31-787-3541; Email: jyhtlcn@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of bronchopulmonary dysplasia (BPD)	diagnosed according to the Jensen Criteria	at 36 weeks of postmenstrual age
Duration of non-invasive ventilation	each of NIV-NAVA, nasal continuous positive airway pressure, high flow nasal cannula	through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Incidence of periventricular leukomalacia (PVL)	diagnosed by brain ultrasound or MRI	through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Duration of invasive ventilation	each of high-frequent oscillatory ventilation, conventional mechanical ventilation, NAVA etc	through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Incidence of air leaks	including pneumothorax, pneumomediastinum and pulmonary interstitial emphysema	through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Incidence of patent ductus arteriosus (PDA)	defined by clinical and/or echocardiographic criteria requiring symptomatic treatment (except prophylaxis)	through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Time to achieve full enteral feeding	day of life when milk amount reaches 100 mL/kg/day or higher	through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Incidence of intraventricular hemorrhage (IVH)	defined by the Papile criteria, using cranial ultrasonography (≥grade 2)	through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Incidence of retinopathy of prematurity (ROP)	defined according to the international classification of ROP (≥stage 2)	through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Total brain volume (mL)	Total brain volume (TBV) will be measured from Brain MRI	term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI
Intracranial volume (mL)	Intracranial volume (ICV) will be measured from Brain MRI	term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI
Relative sizes of volumes of particular regions of interest	relative sizes of volumes of particular regions of interest (ROIs) will be measured from brain MRI	term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI
Bayley Scales of Infant Development III - 2 yr	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).	18-24 months of corrected age
Modified Checklist for Autism in Toddlers (M-CHAT)	autism spectrum disorder screening test result total score 0-2: low risk total score 3-7: moderate risk total score 8-20: high risk	18-24 months of corrected age
MacArthur-Bates Communication Development Inventory	language evaluation questionnaire result The criterion for identifying risk for delayed language development was an expressive vocabulary size <10th percentile	18-24 months of corrected age
Bayley Scales of Infant Development III - 3 yr	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).	33-39 months of age
Child Behavior Checklist (CBCL)	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.	33-39 months of age

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): December 20, 2029
• Study Completion (Estimated): December 20, 2030

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: infant, premature; Noninvasive NAVA
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 2024AN0554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No