Non-invasive Ventilation in Preterm Infants

August 3, 2023 updated by: Universitair Ziekenhuis Brussel
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preterm infants (< 37 weeks GA) supported with non-invasive respiratory support. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Preterm infants on non-invasive respiratory support
All infants on non-invasive respiratory support will be studied. Only infants on NIV-NAVA, will undergo an intervention.
Diagnostic test: Titration procedure

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.

Diagnostic test: Electrical impedance tomography
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.
Diagnostic test: Lung and diaphragm ultrasound

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From birth until study completion, variating between 3 weeks and 3 months
Rate of bronchopulmonary dysplasia (BPD) or death
Time Frame: From birth until gestational age of 36 weeks
Percentage of infants with BPD or death
From birth until gestational age of 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of invasive respiratory support (days)
Time Frame: From birth until study completion, variating between 3 weeks and 3 months
From birth until study completion, variating between 3 weeks and 3 months
Duration of non-invasive respiratory support (days)
Time Frame: From birth until study completion, variating between 3 weeks and 3 months
From birth until study completion, variating between 3 weeks and 3 months
Description of mode of non-invasive respiratory support
Time Frame: From birth until study completion, variating between 3 weeks and 3 months
Use of NIV-NAVA, CPAP, HHHFNC, oxygen therapy
From birth until study completion, variating between 3 weeks and 3 months
Use of surfactant and mode of administration
Time Frame: From birth until study completion, variating between 3 weeks and 3 months
From birth until study completion, variating between 3 weeks and 3 months
Incidence of nosocomial infection
Time Frame: From birth until study completion, variating between 3 weeks and 3 months
From birth until study completion, variating between 3 weeks and 3 months
Use of corticosteroids for the prevention or treatment of BPD
Time Frame: From birth until study completion, variating between 3 weeks and 3 months
Use of any corticosteroid (systemic or local)
From birth until study completion, variating between 3 weeks and 3 months
Length of hospital stay
Time Frame: From birth until study completion, variating between 3 weeks and 3 months
Days of stay in the neonatal unit
From birth until study completion, variating between 3 weeks and 3 months
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
From start of the weaning phase until respiratory support is stopped, up to 10 weeks
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
At inclusion (within 24 hours)
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
At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
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
At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
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)
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
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)
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
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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Julie Lefevere, MD, Universitair Ziekenhuis Brussel
  • Study Director: Filip Cools, PhD, Universitair Ziekenhuis Brussel
  • Study Chair: Brenda Van Delft, Nurse, Universitair Ziekenhuis Brussel
  • Study Chair: Caitlin Jansen, Student, Vrije Universiteit Brussel
  • Study Chair: Lissa De Potter, MD, Universitair Ziekenhuis Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIV study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Database on non-invasive ventilation has the potential to be shared but no concrete plan for sharing individual patient data is made.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premature Birth

Clinical Trials on Titration procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe