NeonatesNCT07000071
Non-invasive Secondary Respiratory Support in Late Preterm and Term Infants
A study testing NCPAP, NIPPV and NHFOV in people with Neonates and Respiratory Distress, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of the present work is to compare between various modes of non-invasive respiratory support (including NCPAP, NIPPV, and NHFOV) as secondary respiratory support modes in late preterm and term neonates as regards the need for reintubation. Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Neonates, Respiratory Distress, Non- Invasive Ventilation
- What is being tested?
- NCPAP, NIPPV and NHFOV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 30 Jan 2022
- 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 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The gestational age (GA) is between 34 and 41 weeks.
- Extubation from invasive mechanical ventilation initiated due to RD, irrespective to the cause of RD.
- Respiratory distress is assessed based on clinical manifestations (tachypnea, nasal flaring, intercostal retractions, diminished air entry, and or grunting)
Who cannot join
- Major congenital anomalies.
- Major cardiac diseases.
- Presence of cardiovascular instability (sepsis, severe dehydration, severe anemia).
- Neurologically insulted neonates who are unable to take adequate spontaneous breathing.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present work is to compare between various modes of non-invasive respiratory support (including NCPAP, NIPPV, and NHFOV) as secondary respiratory support modes in late preterm and term neonates as regards the need for reintubation. Additionally, the study aims at comparing between the three modes concerning the associated morbidity and mortality.
- Conditions
- Neonates, Respiratory Distress, Non- Invasive Ventilation
- Being tested
- NCPAP, NIPPV, NHFOV
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCPAPDevice
Apply nasal continuous positive airway pressure in intubated patients with respiratory distress at time of weaning
NIPPVDevice
Apply nasal intermittent positive pressure ventilation in intubated patients with respiratory distress at time of weaning
NHFOVDevice
Apply nasal high frequency ventilation in intubated patients with respiratory distress at time of weaning
| Study group | Role | What they receive |
|---|---|---|
| Nasal Continuous positive airway pressure (NCPAP) | Active comparator | apply continuous positive airway pressure using nasopharyngeal interface. positive end expiratory pressure (PEEP ) used 5-7 cm H2O. Neonates will be supported with NCPAP following extubation. Receives: Device: NCPAP |
| Nasal intermittent pressure ventilation (NIPPV) | Active comparator | Neonates will be supported with NIPPV following extubation. Receives: Device: NIPPV |
| Nasal high frequency ventilation (NHFOV) | Active comparator | Neonates will be supported with NHFOV following extubation. stating mean airway pressure 8 and can reach upto 15 cm H2O Delta pressure used is 20 Frequency 10 HZ Receives: Device: NHFOV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate
need for reintubation and invasive mechanical ventilation
Measured: 72 hours after weaning
Secondary outcomes (1)
duration of non-invasive ventilation
duration of noninvasive ventilation till patients become weaned to free flow oxygen
Measured: first 72 hours after weaning from mechanical ventillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Jul 2021
- Primary completion30 Dec 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeonatesStudies 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
- 40 participants (actual)
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
- NCT07000071
- Sponsor's protocol ID
- 0201275
- Status last verified
- Jan 2025
- First submitted
- 23 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Secondary Respiratory Support in Late Preterm and Term Infants
- ClinicalTrials.gov ID
- NCT07000071
- Acronym / sponsor ID
- 0201275
- Conditions
- Neonates, Respiratory Distress, Non- Invasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 31 May 2025 (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 compare between various modes of non-invasive respiratory support (including NCPAP, NIPPV, and NHFOV) as secondary respiratory support modes in late preterm and term neonates as regards the need for reintubation. Additionally, the study aims at comparing between the three modes concerning the associated morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nasal Continuous positive airway pressure (NCPAP) | Active comparator | Device: NCPAPapply continuous positive airway pressure using nasopharyngeal interface. positive end expiratory pressure (PEEP ) used 5-7 cm H2O. Neonates will be supported with NCPAP following extubation. |
| Nasal intermittent pressure ventilation (NIPPV) | Active comparator | Device: NIPPVNeonates will be supported with NIPPV following extubation. |
| Nasal high frequency ventilation (NHFOV) | Active comparator | Device: NHFOVNeonates will be supported with NHFOV following extubation. stating mean airway pressure 8 and can reach upto 15 cm H2O Delta pressure used is 20 Frequency 10 HZ |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The gestational age (GA) is between 34 and 41 weeks.
- Extubation from invasive mechanical ventilation initiated due to RD, irrespective to the cause of RD.
- Respiratory distress is assessed based on clinical manifestations (tachypnea, nasal flaring, intercostal retractions, diminished air entry, and or grunting)
Key exclusion criteria (4 listed)
- Major congenital anomalies.
- Major cardiac diseases.
- Presence of cardiovascular instability (sepsis, severe dehydration, severe anemia).
- Neurologically insulted neonates who are unable to take adequate spontaneous breathing.
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 |
|---|---|---|
| NCPAPApply nasal continuous positive airway pressure in intubated patients with respiratory distress at time of weaning | Device | Nasal Continuous positive airway pressure (NCPAP) |
| NIPPVApply nasal intermittent positive pressure ventilation in intubated patients with respiratory distress at time of weaning | Device | Nasal intermittent pressure ventilation (NIPPV) |
| NHFOVApply nasal high frequency ventilation in intubated patients with respiratory distress at time of weaning | Device | Nasal high frequency ventilation (NHFOV) |
Primary outcome
Failure rate
Time frame: 72 hours after weaning
need for reintubation and invasive mechanical ventilation
1 secondary outcome
duration of non-invasive ventilation
Time frame: first 72 hours after weaning from mechanical ventillation
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 31 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NCPAP, NIPPV and NHFOV in people with Neonates and Respiratory Distress, 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 3 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 31 May 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?
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?
Failure rate (time frame: 72 hours after weaning). 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 31 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.