Ventilator Lung; NewbornNCT05706428
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates
A study testing NHFOV and NCPAP in people with Ventilator Lung; Newborn and Hemodynamic Instability, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of respiratory distress in moderate and late preterm infants as regard: I. Primary outcomes: Duration of the non- invasive respiratory support. Read more about this study
- Who is it for?
- Ages 1 hour to 3 days
- Conditions the study is for
- Ventilator Lung; Newborn, Hemodynamic Instability, Echocardiography
- What is being tested?
- NHFOV and NCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 13 Oct 2023
- Phase
- Interventional
- 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 1 hour to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Moderate and late preterm infants born between 32+0 to 36+6 weeks gestation(according to WHO definitions of preterm birth) admitted to the neonatal intensive care unit with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).
Who cannot join
- Any baby intubated for resuscitation or for other reasons.
- Obvious major congenital malformations or known complex congenital heart disease.
- Pulmonary hemorrhage.
- Cardiopulmonary arrest needing prolonged resuscitation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Alexandria, 0356
About this study
Official title: Cardiorespiratory Effects of Nasal High Frequency Ventilation in Moderate and Late Preterm Infants With Respiratory Distress
The aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of respiratory distress in moderate and late preterm infants as regard:
- Primary outcomes:
Read more
- Duration of the non- invasive respiratory support.
- Need of invasive ventilation in the first 72 hours.
- Short-term complications such as air leak syndromes, pulmonary hemorrhage, intraventricular hemorrhage, and nasal trauma.
II. Secondary outcomes:
- Need for surfactant administration.
- Days on invasive mechanical ventilation.
- Days on supplemental oxygen.
- Duration of hospital stay.
- Mortality rate. III. Hemodynamic changes during the period of non-invasive ventilation.
- Being tested
- NHFOV, NCPAP
- Keywords
- Premature infants, Echocardiography
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHFOVDevice
The neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support.
NCPAPDevice
The neonate patients with respiratory distress will have nasal continuous positive airway pressure as an initial mode of respiratory support.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Nasal high-frequency ventilation (NHFV) group (case group): Receives: Device: NHFOV |
| Group II | Placebo comparator | Nasal CPAP group (control group): Receives: Device: NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superior vena cava blood flow in ml/kg/min
The SVC diameter will be visualized from a high parasternal long axis view. The maximum and minimum internal diameters will be then measured. ✓ The SVC flow velocity will be visualized from a low subcostal view and the pulsed Doppler recording will be made at the junction of the SVC and the right atrium. ✓ SVC flow will be calculated using the method described by Kluckow and Evans:(27) SVC flow (ml/kg/min) = [VTI (cm/beat) × 3.14 × (mean SVC diameter2
/4) × heart rate (beat/min)] Body weight in kg 11
Measured: first 3 days of life
Right ventricular output in ml /kg/min
CSA (cm) (Cross sectional area of PV by long axis parasternal RV outflow view - 2D - immediately beneath pulmonary annulus
- mid- systole - inner edge to inner edge) = π x (radius)2 ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Long axis parasternal RV outflow view). ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). ✓ Output (L/min.) COP = SV x HR.
Measured: first 3 days of life
left ventricular output in ml/kg/min
CSA (cm) (Cross sectional area of AV by long axis parasternal view - 2D - immediately beneath aortic annulus - mid- systole - inner edge to inner edge) = π x (radius) 2 . ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Apical 5- chamber view). ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). ✓ Output (L/min.) COP = SV x HR
Measured: first 3 days of life
peak systolic velocity in anterior cerebral artery in cm/sec
Trans-frontellar cranial sonography using Doppler study
Measured: first 3 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Feb 2023
- Primary completion28 Sep 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Lung; NewbornStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
- Investigators
- Nader Abdelminem Fasseh, Study director, Faculty of medicine, Alexandria University, EgyptMohamed Amen Hassan, MBChB, Principal investigator, Faculty of medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706428
- Sponsor's protocol ID
- 0201417
- Status last verified
- Nov 2023
- First submitted
- 21 Jan 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorespiratory Effects of Nasal High Frequency Ventilation in Moderate and Late Preterm Infants With Respiratory Distress
- ClinicalTrials.gov ID
- NCT05706428
- Acronym / sponsor ID
- 0201417
- Keywords
- Premature infants, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 31 Jan 2023 (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.
The aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of respiratory distress in moderate and late preterm infants as regard:
- Primary outcomes:
- Duration of the non- invasive respiratory support.
- Need of invasive ventilation in the first 72 hours.
- Short-term complications such as air leak syndromes, pulmonary hemorrhage, intraventricular hemorrhage, and nasal trauma.
II. Secondary outcomes:
- Need for surfactant administration.
- Days on invasive mechanical ventilation.
- Days on supplemental oxygen.
- Duration of hospital stay.
- Mortality rate. III. Hemodynamic changes during the period of non-invasive ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: NHFOVNasal high-frequency ventilation (NHFV) group (case group): |
| Group II | Placebo comparator | Device: NCPAPNasal CPAP group (control group): |
Who may qualify
- Ages
- 1 hour to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Moderate and late preterm infants born between 32+0 to 36+6 weeks gestation(according to WHO definitions of preterm birth) admitted to the neonatal intensive care unit with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).
Key exclusion criteria (4 listed)
- Any baby intubated for resuscitation or for other reasons.
- Obvious major congenital malformations or known complex congenital heart disease.
- Pulmonary hemorrhage.
- Cardiopulmonary arrest needing prolonged resuscitation.
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 |
|---|---|---|
| NHFOVThe neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support. | Device | Group I |
| NCPAPThe neonate patients with respiratory distress will have nasal continuous positive airway pressure as an initial mode of respiratory support. | Device | Group II |
Primary outcome
Superior vena cava blood flow in ml/kg/min
Time frame: first 3 days of life
The SVC diameter will be visualized from a high parasternal long axis view. The maximum and minimum internal diameters will be then measured. ✓ The SVC flow velocity will be visualized from a low subcostal view and the pulsed Doppler recording will be made at the junction of the SVC and the right atrium. ✓ SVC flow will be calculated using the method described by Kluckow and Evans:(27) SVC flow (ml/kg/min) = [VTI (cm/beat) × 3.14 × (mean SVC diameter2 /4) × heart rate (beat/min)] Body weight in kg 11
Right ventricular output in ml /kg/min
Time frame: first 3 days of life
CSA (cm) (Cross sectional area of PV by long axis parasternal RV outflow view - 2D - immediately beneath pulmonary annulus - mid- systole - inner edge to inner edge) = π x (radius)2 ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Long axis parasternal RV outflow view). ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). ✓ Output (L/min.) COP = SV x HR.
left ventricular output in ml/kg/min
Time frame: first 3 days of life
CSA (cm) (Cross sectional area of AV by long axis parasternal view - 2D - immediately beneath aortic annulus - mid- systole - inner edge to inner edge) = π x (radius) 2 . ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Apical 5- chamber view). ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). ✓ Output (L/min.) COP = SV x HR
peak systolic velocity in anterior cerebral artery in cm/sec
Time frame: first 3 days of life
Trans-frontellar cranial sonography using Doppler study
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 7 Nov 2023.
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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.
Nader Abdelminem Fasseh study director
Faculty of medicine, Alexandria University, Egypt
Mohamed Amen Hassan, MBChB principal investigator
Faculty of medicine, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NHFOV and NCPAP in people with Ventilator Lung; Newborn and Hemodynamic Instability, run by Alexandria University at 1 site in Egypt.
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 1 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 7 Nov 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Superior vena cava blood flow in ml/kg/min (time frame: first 3 days of life). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.