Respiratory Distress Syndrome (RDS)NCT06687083
Nasal High Frequency in Preterm Neonates
A study testing nasal high frequency oscillatory ventilation mode and nasal continuous positive pressure ventilation mode in people with Respiratory Distress Syndrome (RDS) and Neonatal Diseases and Abnormalities, run by Ain Shams University at 1 site in Egypt.
Trial summary
One of the most commonly used non-invasive methods is nasal continuous positive airway pressure (nCPAP). Although high frequency ventilation (HFV) has been applied in many neonatal intensive care units, nasal high frequency oscillatory ventilation (nHFOV) is a relatively new non-invasive modality. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Respiratory Distress Syndrome (RDS), Neonatal Diseases and Abnormalities
- What is being tested?
- nasal high frequency oscillatory ventilation mode and nasal continuous positive pressure ventilation mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2021to 15 Jul 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 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age: 30-34 weeks (determined by date of last menstrual period or ultrasound) and confirmed by Ballard score.
- Recruited immediately after birth Up to 24 hours of age.
- Appropriate weight for the gestational age.
- Spontaneous breathing and clinical signs and symptoms of respiratory distress syndrome (grunting, cyanosis, intercostal and subcostal retractions) or RDS Silverman Score > 5.
Who cannot join
- Major congenital abnormalities, congenital heart disease and diaphragmatic hernia.
- A need for intubation and mandatory ventilation during resuscitation or on the first day of life.
- Perinatal asphyxia (Umbilical cord pH < 7.16, and umbilical cord bicarbonate < 12 mEq/L)
- Pulmonary hemorrhage and severe intraventricular hemorrhage (IVH) on admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive High Frequency Oscillatory Ventilation Versus Continuous Positive Airway Pressure in Preterm Neonates with Respiratory Distress Syndrome
One of the most commonly used non-invasive methods is nasal continuous positive airway pressure (nCPAP). Although high frequency ventilation (HFV) has been applied in many neonatal intensive care units, nasal high frequency oscillatory ventilation (nHFOV) is a relatively new non-invasive modality. The application of nasal high-frequency ventilation with the strategy of lung recruitment will combine benefits of improving gas exchange and decreasing lung injury together with avoiding complication of invasive ventilation.
Read the detailed description
Premature infants with respiratory distress syndrome (RDS) usually require respiratory support . Due to the complications of intubation and mechanical ventilation, in the last decade, attempts have been made to use non-invasive methods in the management of these patients . Over the past few decades, nasal ventilation has been used to control and improve respiratory failure in infants with RDS . nCPAP is a relatively simple and effective therapy in the early management of RDS in newborns . nCPAP is the application of positive pressure to the airways of spontaneously breathing neonates throughout the respiratory cycle . However, some neonates with this therapeutic approach also develop respiratory failure and need mechanical ventilatory support. According to some investigations, 43%-80% of infants with moderate to severe respiratory failure who are initially treated with nCPAP need mechanical ventilation .
In recent years, the beneficial effects of high-frequency ventilators (HFV) have been shown in the management of RDS as well as the use of this mode as the initial mode of support or as a rescue treatment after failure of conventional mechanical ventilation. In high-frequency ventilation, a low tidal volume with a higher frequency than that of physiological respiration is produced. This technique is very effective in eliminating carbon dioxide (CO2). Adequate recruitment of lung volume in this mechanical mode has the main role of protecting and preserving lung architecture as well as potentiating surfactant therapy.
The nHFOV is a non-invasive ventilation mode that applies an oscillatory pressure waveform to the airways using a nasal interface. nHFOV is effective and superior to nasal intermittent positive pressure ventilation in terms of lung CO2 elimination. This mode has been shown to facilitate CO2 elimination, but little is known about its use in neonates. There is increasing evidence of beneficial effects of nHFOV in reducing the duration of ventilator support compared with the effects of nCPAP in RDS. We intended to explore the benefits of nHFOV vs nCPAP in preterm neonates.
- Being tested
- nasal high frequency oscillatory ventilation mode, nasal continuous positive pressure ventilation mode
- Keywords
- preterm neonate, non invasive ventilation, high frequency ventilation, respiratory distress
- Medical subject headings
- Respiratory Distress Syndrome, Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal high frequency oscillatory ventilation modeDevice
Preterm neonates who will be allocated will start nHFOV: (CNO, Medin, Germany). nHFOV will be provided via binasal prongs (Size: small, medium, large; Diameter according to its chart; Medin, Germany).
The initial parameters will be mean airway pressure (MAP) of 6 cm H2O (range 6-10), frequency of 8 Hz (range 8-12) and amplitude will be adjusted until infant's chest showed slight oscillations and amplitude will be 7 (range 7-10).
The fraction of inspired oxygen (FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter.
nasal continuous positive pressure ventilation modeDrug
Preterm neonates who will be allocated to this group to the nCPAP will be started on a pressure of 6-8 cm H2O, FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter
| Study group | Role | What they receive |
|---|---|---|
| nasal high frequency | Experimental | Preterm neonates who will be allocated will start nHFOV. nHFOV will be provided via binasal prongs (Size: small, medium, large; Diameter according to its chart.
The initial parameters will be mean airway pressure (MAP) of 6 cm H2O (range 6-10), frequency of 8 Hz (range 8-12) and amplitude will be adjusted until infant's chest showed slight oscillations and amplitude will be 7 (range 7-10).
The fraction of inspired oxygen (FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter Receives: Device: nasal high frequency oscillatory ventilation mode |
| nasal CPAP | Active comparator | Preterm neonates who will be allocated to this group to the nCPAP will be started on a pressure of 6-8 cm H2O, FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter. Receives: Drug: nasal continuous positive pressure ventilation mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
need for invasive mechanical ventilation
Measured: five days
Secondary outcomes (2)
duration of respiratory support
Measured: one month
mortality
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start15 Jul 2021
- Primary completion15 Jul 2022
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome (RDS)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Ibrahim, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687083
- Sponsor's protocol ID
- nasal high frequency neonates
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data can be shared upon accepted reasons
Publications
Diblasi RM. Nasal continuous positive airway pressure (CPAP) for the respiratory care of the newborn infant. Respir Care. 2009 Sep;54(9):1209-35.
PubMed 19712498Aktas S, Unal S, Aksu M, Ozcan E, Ergenekon E, Turkyilmaz C, Hirfanoglu I, Atalay Y. Nasal HFOV with Binasal Cannula Appears Effective and Feasible in ELBW Newborns. J Trop Pediatr. 2016 Apr;62(2):165-8. doi: 10.1093/tropej/fmv088. Epub 2015 Dec 27.
PubMed 26710797
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive High Frequency Oscillatory Ventilation Versus Continuous Positive Airway Pressure in Preterm Neonates with Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06687083
- Acronym / sponsor ID
- nasal high frequency neonates
- Keywords
- preterm neonate, non invasive ventilation, high frequency ventilation, respiratory distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 13 Nov 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.
One of the most commonly used non-invasive methods is nasal continuous positive airway pressure (nCPAP). Although high frequency ventilation (HFV) has been applied in many neonatal intensive care units, nasal high frequency oscillatory ventilation (nHFOV) is a relatively new non-invasive modality. The application of nasal high-frequency ventilation with the strategy of lung recruitment will combine benefits of improving gas exchange and decreasing lung injury together with avoiding complication of invasive ventilation.
Detailed description
Premature infants with respiratory distress syndrome (RDS) usually require respiratory support . Due to the complications of intubation and mechanical ventilation, in the last decade, attempts have been made to use non-invasive methods in the management of these patients . Over the past few decades, nasal ventilation has been used to control and improve respiratory failure in infants with RDS . nCPAP is a relatively simple and effective therapy in the early management of RDS in newborns . nCPAP is the application of positive pressure to the airways of spontaneously breathing neonates throughout the respiratory cycle . However, some neonates with this therapeutic approach also develop respiratory failure and need mechanical ventilatory support. According to some investigations, 43%-80% of infants with moderate to severe respiratory failure who are initially treated with nCPAP need mechanical ventilation .
In recent years, the beneficial effects of high-frequency ventilators (HFV) have been shown in the management of RDS as well as the use of this mode as the initial mode of support or as a rescue treatment after failure of conventional mechanical ventilation. In high-frequency ventilation, a low tidal volume with a higher frequency than that of physiological respiration is produced. This technique is very effective in eliminating carbon dioxide (CO2). Adequate recruitment of lung volume in this mechanical mode has the main role of protecting and preserving lung architecture as well as potentiating surfactant therapy.
The nHFOV is a non-invasive ventilation mode that applies an oscillatory pressure waveform to the airways using a nasal interface. nHFOV is effective and superior to nasal intermittent positive pressure ventilation in terms of lung CO2 elimination. This mode has been shown to facilitate CO2 elimination, but little is known about its use in neonates. There is increasing evidence of beneficial effects of nHFOV in reducing the duration of ventilator support compared with the effects of nCPAP in RDS. We intended to explore the benefits of nHFOV vs nCPAP in preterm neonates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal high frequency | Experimental | Device: nasal high frequency oscillatory ventilation modePreterm neonates who will be allocated will start nHFOV. nHFOV will be provided via binasal prongs (Size: small, medium, large; Diameter according to its chart. The initial parameters will be mean airway pressure (MAP) of 6 cm H2O (range 6-10), frequency of 8 Hz (range 8-12) and amplitude will be adjusted until infant's chest showed slight oscillations and amplitude will be 7 (range 7-10). The fraction of inspired oxygen (FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter |
| nasal CPAP | Active comparator | Drug: nasal continuous positive pressure ventilation modePreterm neonates who will be allocated to this group to the nCPAP will be started on a pressure of 6-8 cm H2O, FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age: 30-34 weeks (determined by date of last menstrual period or ultrasound) and confirmed by Ballard score.
- Recruited immediately after birth Up to 24 hours of age.
- Appropriate weight for the gestational age.
- Spontaneous breathing and clinical signs and symptoms of respiratory distress syndrome (grunting, cyanosis, intercostal and subcostal retractions) or RDS Silverman Score > 5.
Key exclusion criteria (4 listed)
- Major congenital abnormalities, congenital heart disease and diaphragmatic hernia.
- A need for intubation and mandatory ventilation during resuscitation or on the first day of life.
- Perinatal asphyxia (Umbilical cord pH < 7.16, and umbilical cord bicarbonate < 12 mEq/L)
- Pulmonary hemorrhage and severe intraventricular hemorrhage (IVH) on admission.
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 high frequency oscillatory ventilation modePreterm neonates who will be allocated will start nHFOV: (CNO, Medin, Germany). nHFOV will be provided via binasal prongs (Size: small, medium, large; Diameter according to its chart; Medin, Germany). The initial parameters will be mean airway pressure (MAP) of 6 cm H2O (range 6-10), frequency of 8 Hz (range 8-12) and amplitude will be adjusted until infant's chest showed slight oscillations and amplitude will be 7 (range 7-10). The fraction of inspired oxygen (FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter. | Device | nasal high frequency |
| nasal continuous positive pressure ventilation modePreterm neonates who will be allocated to this group to the nCPAP will be started on a pressure of 6-8 cm H2O, FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter | Drug | nasal CPAP |
Primary outcome
need for invasive mechanical ventilation
Time frame: five days
2 secondary outcomes
duration of respiratory support
Time frame: one month
mortality
Time frame: one month
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 13 Nov 2024.
- Background: PubMed 19712498Diblasi RM. Nasal continuous positive airway pressure (CPAP) for the respiratory care of the newborn infant. Respir Care. 2009 Sep;54(9):1209-35.
- Background: PubMed 26710797Aktas S, Unal S, Aksu M, Ozcan E, Ergenekon E, Turkyilmaz C, Hirfanoglu I, Atalay Y. Nasal HFOV with Binasal Cannula Appears Effective and Feasible in ELBW Newborns. J Trop Pediatr. 2016 Apr;62(2):165-8. doi: 10.1093/tropej/fmv088. Epub 2015 Dec 27.
- Individual participant dataSharing planned: Yes. data can be shared upon accepted reasons
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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 nasal high frequency oscillatory ventilation mode and nasal continuous positive pressure ventilation mode in people with Respiratory Distress Syndrome (RDS) and Neonatal Diseases and Abnormalities, run by Ain Shams 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 4 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 13 Nov 2024. 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?
need for invasive mechanical ventilation (time frame: five days). 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 NCT06687083, which also lists 2 linked publications.
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 13 Nov 2024.