PretermNCT06550219
Evaluation of Nasal Non Invasive Ventilation in Management of Neonates With Respiratory Distress Using Lung Ultrasound
A study testing Nasal humidified heated high flow cannula (NHHHC), Nasal intermittent positive pressure ventilation (NIPPV) and Nasal continuous positive airway pressure NCPAP in people with Preterm and Ventilator Lung; Newborn, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of non-invasive ventilation (nIPPV) , (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates <37 gestational week with moderate to severe RD using LUS as regard: I. Primary outcomes: Duration of non-Invasive ventilation. II. Read more about this study
- Who is it for?
- Ages 1 hour to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Preterm, Ventilator Lung; Newborn
- What is being tested?
- Nasal humidified heated high flow cannula (NHHHC), Nasal intermittent positive pressure ventilation (NIPPV) and Nasal continuous positive airway pressure NCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Obvious major congenital abnormalities.
- Any of the baby intubated for resuscitation or for other reasons.
- Neonates need invasive mechanical ventilation.
- Pulmonary hemorrhage.
- Severe cardiovascular instability.
- Cardiopulmonary arrest needing prolonged resuscitation.
- Birth asphyxia (one-minute Apgar score ≤ 3).
- Major cardiac diseases (not including patent ductus arteriosus).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university, Elshattbi hospital
Alexandria, 0354
Marwa Mohamed Farag, phD, 01288681788 ext. +2, d.marwa.farag@gmail.com
About this study
Official title: Evaluation of Nasal Non Invasive Ventilation Modalities in Management of Neonates With Respiratory Distress Using Lung Ultrasound
This study aims to evaluate the effect of non-invasive ventilation (nIPPV)
, (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates <37 gestational week with moderate to severe RD using LUS as regard: I. Primary outcomes: Duration of non-Invasive ventilation. II. Secondary outcomes: Evaluation LUS over the 1 st 7 days of life or weaning from ventilation. Need for intubation and invasive ventilation. Duration of respiratory support. Need for surfactant. Oxygen saturation index and oxygen index. Broncho-pulmonary dysplasia; grade. Duration of hospital stay
- Conditions
- Preterm, Ventilator Lung; Newborn
- Being tested
- Nasal humidified heated high flow cannula (NHHHC), Nasal intermittent positive pressure ventilation (NIPPV), Nasal continuous positive airway pressure NCPAP, lung ultrasound
- Keywords
- preterm infants, non-invasive ventilation
- Medical subject headings
- Premature Birth, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal humidified heated high flow cannula (NHHHC)Device
Patients in this arm will receive humidified heated high flow using Vapotherm device, USA. Stating with 2 L/min flow and increase gradually till 8L/minute, guided by oxygen requirements.
Nasal intermittent positive pressure ventilation (NIPPV)Device
Patients in this arm will receive both PEEP (positive end expiratory pressure ) and PIP (peak inspiratory pressure) using SLE 5000/6000 device, UK . Pressures will be adjusted according to severity of respiratory distress.
Nasal continuous positive airway pressure NCPAPDevice
Patients in this arm will receive PEEP (positive end expiratory pressure ), stating from 5 mbar to reach maximally 8 mbar.
lung ultrasoundDevice
Lung ultrasound (LUS) machine is a mobile device (Philips HDll XE, USA) with s8-3 probe with a frequency range of 8-3 MHz will be used as ultrasound machine. Throughout the period of non-invasive respiratory support Patient will be monitored by: LUS,Heart rate, Respiratory rate, Mean arterial pressure, Oxygen saturation index, Oxygen index, PaO2, blood gases and Fractional inspired oxygen (Fio2).
| Study group | Role | What they receive |
|---|---|---|
| nasal intermittent positive pressure ventilation group | Experimental | Not described Receives: Device: Nasal intermittent positive pressure ventilation (NIPPV); Device: lung ultrasound |
| nasal continuous positive pressure ventilation group | Experimental | Not described Receives: Device: Nasal continuous positive airway pressure NCPAP; Device: lung ultrasound |
| nasal high flow cannula group | Experimental | Not described Receives: Device: Nasal humidified heated high flow cannula (NHHHC); Device: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of non-Invasive ventilation (NIV)
Describe the days of non-invasive ventilation , described in days number.
Measured: First two weeks of life.
Secondary outcomes (1)
Oxygen saturation index (OSI).
Mean airway pressure (MAP)X Fraction of inspired oxygen (FIO2) X SPO2 ( oxygen saturation) The score of OSI is recorded twice per day for first seven days.
Measured: first one weeks of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start20 Nov 2024
- Primary completion28 May 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550219
- Sponsor's protocol ID
- 0108428
- Status last verified
- Feb 2025
- First submitted
- 4 Aug 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nasal Non Invasive Ventilation Modalities in Management of Neonates With Respiratory Distress Using Lung Ultrasound
- ClinicalTrials.gov ID
- NCT06550219
- Acronym / sponsor ID
- 0108428
- Conditions
- Preterm, Ventilator Lung; Newborn
- Keywords
- preterm infants, non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 28 May 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 12 Aug 2024 (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.
This study aims to evaluate the effect of non-invasive ventilation (nIPPV)
, (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates <37 gestational week with moderate to severe RD using LUS as regard: I. Primary outcomes: Duration of non-Invasive ventilation. II. Secondary outcomes: Evaluation LUS over the 1 st 7 days of life or weaning from ventilation. Need for intubation and invasive ventilation. Duration of respiratory support. Need for surfactant. Oxygen saturation index and oxygen index. Broncho-pulmonary dysplasia; grade. Duration of hospital stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nasal intermittent positive pressure ventilation group | Experimental | Device: Nasal intermittent positive pressure ventilation (NIPPV), Device: lung ultrasound |
| nasal continuous positive pressure ventilation group | Experimental | Device: Nasal continuous positive airway pressure NCPAP, Device: lung ultrasound |
| nasal high flow cannula group | Experimental | Device: Nasal humidified heated high flow cannula (NHHHC), Device: lung ultrasound |
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Obvious major congenital abnormalities.
- Any of the baby intubated for resuscitation or for other reasons.
- Neonates need invasive mechanical ventilation.
- Pulmonary hemorrhage.
- Severe cardiovascular instability.
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 |
|---|---|---|
| Nasal humidified heated high flow cannula (NHHHC)Patients in this arm will receive humidified heated high flow using Vapotherm device, USA. Stating with 2 L/min flow and increase gradually till 8L/minute, guided by oxygen requirements. | Device | nasal high flow cannula group |
| Nasal intermittent positive pressure ventilation (NIPPV)Patients in this arm will receive both PEEP (positive end expiratory pressure ) and PIP (peak inspiratory pressure) using SLE 5000/6000 device, UK . Pressures will be adjusted according to severity of respiratory distress. | Device | nasal intermittent positive pressure ventilation group |
| Nasal continuous positive airway pressure NCPAPPatients in this arm will receive PEEP (positive end expiratory pressure ), stating from 5 mbar to reach maximally 8 mbar. | Device | nasal continuous positive pressure ventilation group |
| lung ultrasoundLung ultrasound (LUS) machine is a mobile device (Philips HDll XE, USA) with s8-3 probe with a frequency range of 8-3 MHz will be used as ultrasound machine. Throughout the period of non-invasive respiratory support Patient will be monitored by: LUS,Heart rate, Respiratory rate, Mean arterial pressure, Oxygen saturation index, Oxygen index, PaO2, blood gases and Fractional inspired oxygen (Fio2). | Device | nasal continuous positive pressure ventilation group, nasal high flow cannula group, nasal intermittent positive pressure ventilation group |
Primary outcome
Duration of non-Invasive ventilation (NIV)
Time frame: First two weeks of life.
Describe the days of non-invasive ventilation , described in days number.
1 secondary outcome
Oxygen saturation index (OSI).
Time frame: first one weeks of life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal humidified heated high flow cannula (NHHHC), Nasal intermittent positive pressure ventilation (NIPPV) and Nasal continuous positive airway pressure NCPAP in people with Preterm and Ventilator Lung; Newborn, 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 0 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Feb 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa M Farag, PhD (01288681788, d.marwa.farag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of non-Invasive ventilation (NIV) (time frame: First two weeks of life.). 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 4 Feb 2025.