Non-invasive Ventilation in Preterm Infants

Not Applicable

Recruiting

• Conditions: Respiratory Distress Syndrome; Premature Birth; Ventilator Lung; Newborn
• Interventions: Diagnostic Test: Titration procedure; Diagnostic Test: Electrical impedance tomography; Diagnostic Test: Lung and diaphragm ultrasound

• Registration Number: NCT05987800
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional. For all participants prospective data collection will be conducted by chart review and by downloading ventilatory data from the ventilator. A registration of respiratory severity score will be done by a caregiver during the weaning period. This consists of a visual assessment of the work of breathing every 2 hours. For participants on NIV-NAVA consenting to the interventional part of the study a titration procedure will be conducted, afterwards serial electrical impedance tomography and lung and diaphragm ultrasound measurements will be done.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-02
• Study Start: 2023-02-01
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Preterm infants (< 37 weeks GA) supported with non-invasive respiratory support for at least 24 hours. Non-invasive respiratory support can consist of non-invasive NAVA, nasal continuous positive airway pressure (nCPAP) or high flow nasal canula (flow > 2 liters/min).The support can be given as primary respiratory support or as respiratory support after weaning from invasive ventilation (= after extubation).
• Infants can only be enrolled after written and signed informed consent by the parents.

Exclusion Criteria

• Infant born after a gestational age of 37 weeks or more.
• Infants with major congenital malformations or chromosomal abnormalities (eg trisomy 18, congenital diaphragmatic hernia...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preterm infants on non-invasive respiratory support	Titration procedure	All infants on non-invasive respiratory support will be studied. Only infants on less than 32 weeks of gestation at birth, will undergo an intervention.
Preterm infants on non-invasive respiratory support	Lung and diaphragm ultrasound	All infants on non-invasive respiratory support will be studied. Only infants on less than 32 weeks of gestation at birth, will undergo an intervention.
Preterm infants on non-invasive respiratory support	Electrical impedance tomography	All infants on non-invasive respiratory support will be studied. Only infants on less than 32 weeks of gestation at birth, will undergo an intervention.

Primary Outcome Measures

Name	Time	Method
Total duration of respiratory support	From birth until study completion, variating between 3 weeks and 3 months	Total number of days of invasive and non-invasive respiratory support
Rate of bronchopulmonary dysplasia (BPD) or death	From birth until gestational age of 36 weeks	Percentage of infants with BPD or death

Secondary Outcome Measures

Name	Time	Method
Duration of non-invasive respiratory support (days)	From birth until study completion, between 3 weeks and 3 months
Respiratory severity score (RSS)	From start of the weaning phase until respiratory support is stopped, up to 10 weeks	RSS will be measured during the weaning phase of non-invasive respiratory support
Description of mode of non-invasive respiratory support	From birth until study completion, between 3 weeks and 3 months	Use of NIV-NAVA, CPAP, high flow nasal cannula, oxygen therapy
Duration of invasive respiratory support (days)	From birth until study completion, variating between 3 weeks and 3 months
Lung ultrasound score	At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks	Lung ultrasound score will be scored at several time points
Use of surfactant and mode of administration	From birth until study completion, between 3 weeks and 3 months
Use of corticosteroids for the prevention or treatment of BPD	From birth until study completion, between 3 weeks and 3 months	Use of any corticosteroid (systemic or local)
Length of hospital stay	From birth until study completion, between 3 weeks and 3 months	Days of stay in the neonatal unit
Incidence of nosocomial infection	From birth until study completion, between 3 weeks and 3 months
NIV-NAVA breakpoint	At inclusion (within 24 hours)	Definition of the breakpoint for patients of NIV-NAVA after following a prespecified titration protocol
Diaphragm ultrasound	At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks	Measurement of diaphragm thickness with ultrasound
Silent Spaces	At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks	Parts (in % of global lung volume) of the lung that are not ventilated as measured with electrical impedance tomography (EIT)
Tidal volume (TV)	At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks	Percentage of TV per 'Region of Interest' (ROI) as measured with electrical impedance tomography (EIT)
Center of Ventilation (CoV)	At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks	As measured with electrical impedance tomography (EIT)

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussel, Belgium