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Completed

NCT Number: NCT05987800

Non-invasive Ventilation in Preterm Infants

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.

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Key information

Conditions

Premature Birth Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases Ventilator Lung; Newborn Ventilator-Induced Lung Injury

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

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

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…)

Treatment and study plan

Titration procedure

Diagnostic Test

The NAVA level will be reduced to 0,5 cmH2O/microvolt (µV) for 3 minutes as a starting point. Limit peak pressure will be set to 35 cmH2O (the maxi-mum pressure that can be delivered to the patient is cut off at 30 cmH2O). Other ventilator settings will be left unchanged and are as clinically indicated.

Starting from a NAVA level of 0,5 cmH20/µV the level will be increased by 0,5 cmH2O/µV every 3 minutes until reaching a maximum NAVA level of 2,5 cmH2O/µV.

Electrical impedance tomography

Diagnostic Test

This is a non-invasive technique consisting of the application of a non-adhesive single-use patient belt to monitor regional changes in lung aeration at the bedside.

Lung and diaphragm ultrasound

Diagnostic Test

Lung ultrasound is a non-invasive technique used to diagnose lung pathology and to monitor lung condition. This technique is part of the standard of care for preterm infants in our neonatal unit. Lung ultrasound scores are calculated at each time an ultrasound is performed.

Ultrasound of the diaphragm consists of a short additional measurement of diaphragm thickness and thickening fraction and will be done at the same time of the lung ultrasound following a standardized procedure.

Primary outcomes

  1. Total duration of respiratory support

    Time frame: From birth until study completion, variating between 3 weeks and 3 months

    Total number of days of invasive and non-invasive respiratory support

  2. Rate of bronchopulmonary dysplasia (BPD) or death

    Time frame: From birth until gestational age of 36 weeks

    Percentage of infants with BPD or death

Secondary outcomes

  1. Duration of invasive respiratory support (days)

    Time frame: From birth until study completion, variating between 3 weeks and 3 months

  2. Duration of non-invasive respiratory support (days)

    Time frame: From birth until study completion, between 3 weeks and 3 months

  3. Description of mode of non-invasive respiratory support

    Time frame: From birth until study completion, between 3 weeks and 3 months

    Use of NIV-NAVA, CPAP, high flow nasal cannula, oxygen therapy

  4. Use of surfactant and mode of administration

    Time frame: From birth until study completion, between 3 weeks and 3 months

  5. Incidence of nosocomial infection

    Time frame: From birth until study completion, between 3 weeks and 3 months

  6. Use of corticosteroids for the prevention or treatment of BPD

    Time frame: From birth until study completion, between 3 weeks and 3 months

    Use of any corticosteroid (systemic or local)

  7. Length of hospital stay

    Time frame: From birth until study completion, between 3 weeks and 3 months

    Days of stay in the neonatal unit

  8. Respiratory severity score (RSS)

    Time frame: 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

  9. NIV-NAVA breakpoint

    Time frame: At inclusion (within 24 hours)

    Definition of the breakpoint for patients of NIV-NAVA after following a prespecified titration protocol

  10. Lung ultrasound score

    Time frame: 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

  11. Diaphragm ultrasound

    Time frame: 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

  12. Silent Spaces

    Time frame: 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)

  13. Tidal volume (TV)

    Time frame: 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)

  14. Center of Ventilation (CoV)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
May 12, 2026

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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