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

Recruiting

• Conditions: Preterm Infant

• Registration Number: NCT06786039
• Lead Sponsor: Korea University Anam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-14
• Study Start: 2025-01-20
• Study First Posted: 2025-01-22
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-17
• Primary Completion: 2029-12-20
• Study Completion: 2030-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) failure	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 Outcome Measures

Name	Time	Method
Time to achieve full enteral feeding	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
Rate of bronchopulmonary dysplasia (BPD)	at 36 weeks of postmenstrual age	diagnosed according to the Jensen Criteria
Duration of non-invasive ventilation	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
Incidence of periventricular leukomalacia (PVL)	through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months	diagnosed by brain ultrasound or MRI
Duration of invasive ventilation	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
Incidence of air leaks	through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months	including pneumothorax, pneumomediastinum and pulmonary interstitial emphysema
Incidence of patent ductus arteriosus (PDA)	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)
Incidence of intraventricular hemorrhage (IVH)	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)
Incidence of retinopathy of prematurity (ROP)	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)
Total brain volume (mL)	term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI	Total brain volume (TBV) will be measured from Brain MRI
Intracranial volume (mL)	term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI	Intracranial volume (ICV) will be measured from Brain MRI
Relative sizes of volumes of particular regions of interest	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
Bayley Scales of Infant Development III - 2 yr	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).
Modified Checklist for Autism in Toddlers (M-CHAT)	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
MacArthur-Bates Communication Development Inventory	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
Bayley Scales of Infant Development III - 3 yr	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).
Child Behavior Checklist (CBCL)	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.

Trial Locations

Locations (2)

Seoul National Bundang Hospital NICU; 🇰🇷 Seongnam-si, Kyungki-do, Korea, Republic of

Korea University Anam Hospital, NICU; 🇰🇷 Seoul, Korea, Republic of