Respiratory DiseaseNCT05079412
Does NIV-NAVA Improve Diaphragmatic Function in Preterm Infants
An observational study of Respiratory Disease, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Non-Invasive Positive Pressure Ventilation (NIPPV) provides un-synchronized positive pressure and considered to be superior to nCPAP in preventing extubation failure. Recently, Non-Invasive Ventilation Neurally-Adjusted Ventilatory Assist (NIV-NAVA) was introduced to NICU. Read more about this study
- Who is it for?
- Ages 2 to 4 weeks
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Chest ultrasound
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants that were born between 22 0/7 to 29 6/7 weeks gestation and were admitted to the NICU at Mount Sinai Health System will be eligible for the study. Infants will be enrolled after obtaining parents' consent and Research Ethics Board approval
Who may be able to join
- Infants that were born at 22 0/7 to 29 6/7 weeks gestation and admitted to the NICU at Mount Sinai Health System.
- Infants that are on NIPPV or NIV-NAVA respiratory support for at least 24 hours at the time of enrolment.
Who cannot join
- Infants with congenital anomalies.
- Infants with known genetic disorder.
- Infants with known lung malformation or diaphragm dysfunction.
- Infants of whom parents declined consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Non-Invasive Ventilation Neurally-Adjusted Ventilatory Assist (NIV-NAVA) Improve Diaphragmatic Function in Preterm Infants?
Non-Invasive Positive Pressure Ventilation (NIPPV) provides un-synchronized positive pressure and considered to be superior to nCPAP in preventing extubation failure. Recently, Non-Invasive Ventilation Neurally-Adjusted Ventilatory Assist (NIV-NAVA) was introduced to NICU. NAVA is a ventilation mode that uses the electrical activity of the patient's diaphragm (Edi-signal) to guide both timing and magnitude of the support. However, it is unknown whether NIV-NAVA is superior to NIPPV in preventing extubation failure and preventing BPD.
Hence, the investigators aim to compare the effect of NIPPV and NIV-NAVA on diaphragm function in premature infants with RDS or evolving BPD. Our hypothesis is that infants treated with NIV-NAVA will have improved diaphragmatic function and lung scoring.
Read the detailed description
STUDY POPULATION Premature infants with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported with NIPPV or NIV-NAVA.
Inclusion criteria
- Infants that were born at 22 0/7 to 29 6/7 weeks gestation and admitted to the NICU at Mount Sinai Health System.
- Infants that are on NIPPV or NIV-NAVA respiratory support for at least 24 hours at the time of enrolment.
Exclusion criteria
- Infants with congenital anomalies.
- Infants with known genetic disorder.
- Infants with known lung malformation or diaphragm dysfunction.
- Infants of whom parents declined consent.
Study Design and settings:
This is a prospective cohort study that includes premature infants born at 22 0/7 to 29 6/7 weeks GA in Mount Sinai Hospital and admitted to the NICU. Written consent will be obtained from parents or guardians prior to enrolment in the study. Enrolment of eligible infants will start after obtaining approval from Mount Sinai Research Ethics Board and parent's consent. Recruitment will be done over one year, and the investigators are expecting to recruit about 30 infants in the NIPPV group and similar number in the NIV-NAVA group.
Time of assessment; Eligible infants will be identified by a member of the infant's circle of care. Parents of infants who are eligible for the study will be approached for consent. Chest ultrasound (lung ultrasound and diaphragmatic function assessment) will be performed at > 7 days postnatally, provided that the infant is supported by either NIPPV or NIV-NAVA for at least 24 hours. CUS will be done prior to feeding to avoid any concerns of a full stomach on diaphragmatic assessment.
Study procedure: Functional assessment of the diaphragm combined with lung ultrasound examination will be done by one of the investigators.
Lung ultrasound assessment technique; Lung ultrasounds will be performed in a standardized manner. A longitudinal scan of the anterior and lateral chest walls will be performed. Three chest areas for each side (upper anterior, lower anterior, and lateral) will be assessed. Each area will have a score of 0 to 3 points with a total score between 0 to 18, which inversely correlates with lung aeration.
Diaphragmatic assessment technique; Diaphragm assessment will be performed in the supine position. To measure diaphragmatic excursion, the curvilinear probe will be placed on the lower intercostal spaces between the mid-clavicular and anterior axillary lines on the right side and between the anterior and mid-axillary lines for the left side. Using the B mode, the proper exploration line of the diaphragm will be detected by directing the beam perpendicular to the posterior third of the right hemidiaphragm. By M mode, the cyclic caudal diaphragmatic displacement with respiration will be measured as the perpendicular distance between the most caudal point of the liver or spleen at the end of expiration and the end of inspiration. The average of three respiratory cycles will be taken.
The assessment of the diaphragmatic efficiency as a pressure generator will be evaluated using the diaphragmatic thickness fraction. Diaphragmatic thickness will be measured at the apposition zone which can be obtained by placing the linear transducer above the 10th rib in the mid-axillary or anterior axillary lines in the right intercostal spaces. By B mode, three distinct layers will be seen, the diaphragm as a hypo-echoic area bordered by two clear echogenic lines of the pleural membrane (upper line) and the peritoneal membrane (lower line). Using M-mode tracing, inspiratory diaphragmatic thickness will be measured as the maximum perpendicular distance between pleural and peritoneal layers and by the same way expiratory diaphragmatic thickness will be recorded. diaphragmatic thickness fraction will be calculated using the following formula:
diaphragmatic thickness fraction = [(inspiratory thickness - expiratory thickness)/expiratory thickness] x 100.
The average of the calculated diaphragmatic thickness fraction from three respiratory cycles will be estimated. The higher scores the better the diaphragmatic function. All Chest ultrasound assessments will be undertaken using a standard aseptic technique.
- Conditions
- Respiratory Disease
- Being tested
- Chest ultrasound
- Keywords
- preterm, neonates, Ultrasound, non-invasive, ventilation, Diaphragm, Lung, NIV-NAVA, NIPPV
- Medical subject headings
- Respiration Disorders, Premature Birth, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest ultrasoundOther
Chest ultrasound will be performed to eligiable (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. Both diaphragmatic function and lung ultrasound score will performed. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
| Study group | Role | What they receive |
|---|---|---|
| NIV-NAVA group | Premature infants (22 0/7 to 29 6/7 weeks gestation) with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported by NIV-NAVA for at least 24 hours are enrolled in this arm after obtaining parents' consent. Receives: Other: Chest ultrasound | |
| NIPPV group | Premature infants (22 0/7 to 29 6/7 weeks gestation) with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported by NIPPV for at least 24 hours are enrolled in this arm after obtaining parents' consent. Receives: Other: Chest ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the diaphragmatic Thickness (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV)
Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. diaphragmatic Thickness (in millimetre) will be measured. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
Measured: 1 YEAR
Evaluation of the diaphragmatic excursion (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV)
Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. diaphragmatic Excursion (in millimetre) will be measured. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
Measured: 1 YEAR
Secondary outcomes (1)
Lung ultrasound score for infants in NIV-NAVA group vs NIPPV group
Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. Lung ultrasound score will performed. Lung ultrasound score range from 0 to 18 points. while 0 points (good score) means normal lung, 18 points (bad score) mean severely affected lung. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Feb 2021
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Mohamed, Mount Sinai Hospital, Canada
- Investigators
- Adel Mohamed, MD, Principal investigator, Mount Sinai Hospital- Toronto, ON, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079412
- Sponsor's protocol ID
- 19-0324-E
- Status last verified
- Mar 2023
- First submitted
- 30 Sep 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elkhouli M, Tamir-Hostovsky L, Ibrahim J, Nasef N, Mohamed A. Ultrasonographic assessment of diaphragmatic function in preterm infants on non-invasive neurally adjusted ventilatory assist (NIV-NAVA) compared to nasal intermittent positive-pressure ventilation (NIPPV): a prospective observational study. Eur J Pediatr. 2023 Feb;182(2):731-739. doi: 10.1007/s00431-022-04738-8. Epub 2022 Dec 2.
PubMed 36459227
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Non-Invasive Ventilation Neurally-Adjusted Ventilatory Assist (NIV-NAVA) Improve Diaphragmatic Function in Preterm Infants?
- ClinicalTrials.gov ID
- NCT05079412
- Acronym / sponsor ID
- 19-0324-E
- Conditions
- Respiratory Disease
- Keywords
- preterm, neonates, Ultrasound, non-invasive, ventilation, Diaphragm, Lung, NIV-NAVA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-Invasive Positive Pressure Ventilation (NIPPV) provides un-synchronized positive pressure and considered to be superior to nCPAP in preventing extubation failure. Recently, Non-Invasive Ventilation Neurally-Adjusted Ventilatory Assist (NIV-NAVA) was introduced to NICU. NAVA is a ventilation mode that uses the electrical activity of the patient's diaphragm (Edi-signal) to guide both timing and magnitude of the support. However, it is unknown whether NIV-NAVA is superior to NIPPV in preventing extubation failure and preventing BPD.
Hence, the investigators aim to compare the effect of NIPPV and NIV-NAVA on diaphragm function in premature infants with RDS or evolving BPD. Our hypothesis is that infants treated with NIV-NAVA will have improved diaphragmatic function and lung scoring.
Detailed description
STUDY POPULATION Premature infants with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported with NIPPV or NIV-NAVA.
Inclusion criteria
- Infants that were born at 22 0/7 to 29 6/7 weeks gestation and admitted to the NICU at Mount Sinai Health System.
- Infants that are on NIPPV or NIV-NAVA respiratory support for at least 24 hours at the time of enrolment.
Exclusion criteria
- Infants with congenital anomalies.
- Infants with known genetic disorder.
- Infants with known lung malformation or diaphragm dysfunction.
- Infants of whom parents declined consent.
Study Design and settings:
This is a prospective cohort study that includes premature infants born at 22 0/7 to 29 6/7 weeks GA in Mount Sinai Hospital and admitted to the NICU. Written consent will be obtained from parents or guardians prior to enrolment in the study. Enrolment of eligible infants will start after obtaining approval from Mount Sinai Research Ethics Board and parent's consent. Recruitment will be done over one year, and the investigators are expecting to recruit about 30 infants in the NIPPV group and similar number in the NIV-NAVA group.
Time of assessment; Eligible infants will be identified by a member of the infant's circle of care. Parents of infants who are eligible for the study will be approached for consent. Chest ultrasound (lung ultrasound and diaphragmatic function assessment) will be performed at > 7 days postnatally, provided that the infant is supported by either NIPPV or NIV-NAVA for at least 24 hours. CUS will be done prior to feeding to avoid any concerns of a full stomach on diaphragmatic assessment.
Study procedure: Functional assessment of the diaphragm combined with lung ultrasound examination will be done by one of the investigators.
Lung ultrasound assessment technique; Lung ultrasounds will be performed in a standardized manner. A longitudinal scan of the anterior and lateral chest walls will be performed. Three chest areas for each side (upper anterior, lower anterior, and lateral) will be assessed. Each area will have a score of 0 to 3 points with a total score between 0 to 18, which inversely correlates with lung aeration.
Diaphragmatic assessment technique; Diaphragm assessment will be performed in the supine position. To measure diaphragmatic excursion, the curvilinear probe will be placed on the lower intercostal spaces between the mid-clavicular and anterior axillary lines on the right side and between the anterior and mid-axillary lines for the left side. Using the B mode, the proper exploration line of the diaphragm will be detected by directing the beam perpendicular to the posterior third of the right hemidiaphragm. By M mode, the cyclic caudal diaphragmatic displacement with respiration will be measured as the perpendicular distance between the most caudal point of the liver or spleen at the end of expiration and the end of inspiration. The average of three respiratory cycles will be taken.
The assessment of the diaphragmatic efficiency as a pressure generator will be evaluated using the diaphragmatic thickness fraction. Diaphragmatic thickness will be measured at the apposition zone which can be obtained by placing the linear transducer above the 10th rib in the mid-axillary or anterior axillary lines in the right intercostal spaces. By B mode, three distinct layers will be seen, the diaphragm as a hypo-echoic area bordered by two clear echogenic lines of the pleural membrane (upper line) and the peritoneal membrane (lower line). Using M-mode tracing, inspiratory diaphragmatic thickness will be measured as the maximum perpendicular distance between pleural and peritoneal layers and by the same way expiratory diaphragmatic thickness will be recorded. diaphragmatic thickness fraction will be calculated using the following formula:
diaphragmatic thickness fraction = [(inspiratory thickness - expiratory thickness)/expiratory thickness] x 100.
The average of the calculated diaphragmatic thickness fraction from three respiratory cycles will be estimated. The higher scores the better the diaphragmatic function. All Chest ultrasound assessments will be undertaken using a standard aseptic technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV-NAVA group | – | Other: Chest ultrasoundPremature infants (22 0/7 to 29 6/7 weeks gestation) with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported by NIV-NAVA for at least 24 hours are enrolled in this arm after obtaining parents' consent. |
| NIPPV group | – | Other: Chest ultrasoundPremature infants (22 0/7 to 29 6/7 weeks gestation) with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported by NIPPV for at least 24 hours are enrolled in this arm after obtaining parents' consent. |
Who may qualify
- Ages
- 2 to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants that were born between 22 0/7 to 29 6/7 weeks gestation and were admitted to the NICU at Mount Sinai Health System will be eligible for the study. Infants will be enrolled after obtaining parents' consent and Research Ethics Board approval
Key inclusion criteria (2 listed)
- Infants that were born at 22 0/7 to 29 6/7 weeks gestation and admitted to the NICU at Mount Sinai Health System.
- Infants that are on NIPPV or NIV-NAVA respiratory support for at least 24 hours at the time of enrolment.
Key exclusion criteria (4 listed)
- Infants with congenital anomalies.
- Infants with known genetic disorder.
- Infants with known lung malformation or diaphragm dysfunction.
- Infants of whom parents declined consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest ultrasoundChest ultrasound will be performed to eligiable (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. Both diaphragmatic function and lung ultrasound score will performed. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status. | Other | NIPPV group, NIV-NAVA group |
Primary outcome
Evaluation of the diaphragmatic Thickness (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV)
Time frame: 1 YEAR
Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. diaphragmatic Thickness (in millimetre) will be measured. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
Evaluation of the diaphragmatic excursion (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV)
Time frame: 1 YEAR
Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. diaphragmatic Excursion (in millimetre) will be measured. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
1 secondary outcome
Lung ultrasound score for infants in NIV-NAVA group vs NIPPV group
Time frame: 1 YEAR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 36459227Elkhouli M, Tamir-Hostovsky L, Ibrahim J, Nasef N, Mohamed A. Ultrasonographic assessment of diaphragmatic function in preterm infants on non-invasive neurally adjusted ventilatory assist (NIV-NAVA) compared to nasal intermittent positive-pressure ventilation (NIPPV): a prospective observational study. Eur J Pediatr. 2023 Feb;182(2):731-739. doi: 10.1007/s00431-022-04738-8. Epub 2022 Dec 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adel Mohamed, MD principal investigator
Mount Sinai Hospital- Toronto, ON, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the diaphragmatic Thickness (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV) (time frame: 1 YEAR). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.