Noninvasive VentilationNCT06620107
NHFOV Vs NIPPV Post-extubation in Preterm Neonates
A study testing noninvasive high frequency oscillation ventilation and noninvasive positive pressure ventilation in people with Noninvasive Ventilation, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
comparison between Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) and Noninvasive High Frequency Oscillation Ventilation (NHFOV) post-extubation in preterm neonates as regards the efficacy and their possible complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Noninvasive Ventilation
- What is being tested?
- noninvasive high frequency oscillation ventilation and noninvasive positive pressure ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2023to 20 Jan 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm neonates with gestational age between 32 and 36 weeks and on mechanical ventilation ready to be extubated.
- When the case is ready for extubation , will receive at least one loading dose of caffeine citrate (20 mg/kg/dose) and daily maintenance dose of 5 mg/kg/dose.
- Criteria for extubation:
- Blood gas analysis: PH \> 7.25 and PaCO2 ≤ 60 mmHg.
- Airway pressure (Paw) of 7 to 8 cmH2O.
- Required fraction of inspired oxygen (FiO2) ≤ 30%.
- Sufficient spontaneous breathing by clinical evaluation.
Who cannot join
- Full term neonates.
- Preterm neonates who will not require intubation.
- Preterm neonates with one of the following criteria:
- birth weight \> 900 gms , major congenital anomalies, upper airway anomalies, neuromuscular diseases, surgical cases, intraventricular hemorrhage grade IV.
- Cases that require reintubation after more than 72 hours of extubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive High Frequency Oscillation Ventilation (NHFOV) in Comparison to Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) As Post-extubation Support in Preterm Neonates
comparison between Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) and Noninvasive High Frequency Oscillation Ventilation (NHFOV) post-extubation in preterm neonates as regards the efficacy and their possible complications.
Read the detailed description
The global definition of preterm infant by the World Health Organization is any infant born before 37 weeks of gestation. Annually, an estimated 15 million (11.1%) preterm infants are born worldwide. Preterm birth is further classified as extremely preterm (\<28 weeks), very preterm (28 to \<32 weeks), and moderate (32 to \<34 weeks) to late preterm (34 to \<37 weeks).
Prematurity has been associated with several risk factors, such as history of previous preterm birth, pregnancy induced hypertension, premature rupture of fetal membranes, multiple pregnancy, bleeding during pregnancy, history of abortion, fetal malformation, inadequate antenatal care, polyhydramnios and previous caesarean section.
Preterm neonates are at greater risk of a range of short-term and long-term morbidities. Respiratory distress syndrome (RDS) is one of the most common causes of morbidity and mortality in preterm infants. RDS is characterized by a lack of lung surfactant. Insufficient surfactant production or secretion results in higher alveolar surface tension, leading to atelectasis and impaired gas exchange. Respiratory distress typically manifests in newborns as tachypnea, intercostal retractions, nasal flaring, grunting, and cyanosis.
Invasive mechanical ventilation (IMV) increases survival in preterm infants with severe RDS. However, prolonged intubation and mechanical ventilation of preterm infants increases the risk of life-threatening complications including, ventilator induced lung injury and airway inflammation leading to bronchopulmonary dysplasia, and nosocomial pneumonia, and also increases the risk of a poor neurodevelopmental outcome. Therefore, when caring for premature infants, clinicians should focus on weaning from IMV as expeditiously as possible to noninvasive respiratory support (NRS).
There are many strategies and criteria for weaning, including evaluation of ventilatory parameters, clinical/biochemical criteria, and predictive indices of extubation that can be followed by or combined with spontaneous breathing trials or gradual withdrawal from ventilatory support.
Noninvasive respiratory support modalities include continuous positive airway pressure (CPAP), high flow nasal cannula (HFNC), noninvasive intermittent positive pressure ventilation (NIPPV), bilevel CPAP (BiPAP) and noninvasive high frequency oscillation ventilation (NHFOV).
NIPPV is a time cycled, pressure limited mode of ventilation. Conventional ventilator is used to generate two levels of pressures, namely, Peak inspiratory pressure and positive end expiratory pressure. Additionally, a backup rate is provided typically using longer inspiratory time. The main drawback of neonatal NIPPV is the lack of synchronization, which is difficult to achieve and is often unavailable.
NHFOV is the application of a bias flow generating a continuous distending positive pressure with superimposed oscillations which have a constant frequency and an active expiratory phase. NHFOV combines the advantages of NCPAP and high-frequency ventilation, making it more effective at maintaining alveolar stability, eliminating CO2, and limiting barotrauma.
The study assumed that NHFOV is more efficacious than NIPPV as regard prevention of the need for re-intubation in preterm infants with gestational age between 32 and 36 weeks and 6 days after their 1st extubation.
- Conditions
- Noninvasive Ventilation
- Being tested
- noninvasive high frequency oscillation ventilation, noninvasive positive pressure ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive high frequency oscillation ventilationDevice
cases of group A extubated on NHFOV, and it will be provided by CNO, Medin device, Germany) via binasal prongs with the following parameters:
- MAP of 6 cmH2O and will be titrated targeting a FiO2 ≤ 25-30%, maximum FiO2 will be 40% and target oxygen saturation will be 90-95%.
- Frequency of 8 Hz and can be changed within the range of 8-12 Hz.
- Amplitude of 7 cmH2O and can be titrated within the range of 7-10 cmH2O according to PaCO2.
noninvasive positive pressure ventilationDevice
NIPPV will be provided by any type of neonatal ventilator available in the unit via binasal prongs starting with the following parameters:
- Positive end expiratory pressure (PEEP) of 5 cmH2O and can be titrated to 8 cmH2O according to the oxygenation .
- Peak inspiratory pressure (PIP) of 15 cmH2O and can be titrated to 25 cmH2O ,according to oxygenation , PaCO2 level and the chest expansion .
- FiO2 ≤ 25-30% and can be increased to 40 % maximally targeting oxygen saturation of 90-95% .
- Inspiratory time of 0.40-0.50 s .
- Rate of 30 bpm and can be increased to maximum 50 bpm .
- Synchronization will not be applied.
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive high frequency oscillation ventilation | Active comparator | preterm neonates with GA of 32 to 36 weeks ready for extubation Receives: Device: noninvasive high frequency oscillation ventilation |
| Noninvasive intermittent positive pressure ventilation | Active comparator | preterm neonates with GA of 32 to 36 weeks ready for extubation Receives: Device: noninvasive positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
reintubation and the duration of respiratory support
- The number of cases that required re-intubation and the time of failure of extubation in hours.
- Duration of different types of respiratory support since birth till discharge from NICU.
Measured: from the date of birth till the date of discharge from NICU or death (assessed up to 3 months)..
Secondary outcomes (1)
complications
- Airleak syndromes.
- Apnea rate.
- Nasal septal injury.
- Bronchopulmonary dysplasia.
- Intraventricular hemorrhage ≥ 2nd grade.
- Hemodynamically significant PDA.
- Retinopathy of prematurity ≥ 2nd stage.
- Necrotizing enterocolitis ≥ 2nd stage.
- Frequency of vomiting.
- Feeding intolerance.
- Weekly weight gain until NICU discharge.
- Duration of hospitalization.
- Mortality during stay in hospital.
Measured: from the date of birth till the date of discharge from NICU or death (assessed up to 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start20 Jan 2023
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
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 Noninvasive VentilationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Mahmoud Hassan Abouseada, Kafrelsheikh University
- Investigators
- Heba SM El-Mahdy, Study chair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620107
- Sponsor's protocol ID
- NHFOV vs NIPPV in neonates
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi Y, Muniraman H, Biniwale M, Ramanathan R. A Review on Non-invasive Respiratory Support for Management of Respiratory Distress in Extremely Preterm Infants. Front Pediatr. 2020 May 28;8:270. doi: 10.3389/fped.2020.00270. eCollection 2020.
PubMed 32548084
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive High Frequency Oscillation Ventilation (NHFOV) in Comparison to Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) As Post-extubation Support in Preterm Neonates
- ClinicalTrials.gov ID
- NCT06620107
- Acronym / sponsor ID
- NHFOV vs NIPPV in neonates
- Conditions
- Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 1 Oct 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.
comparison between Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) and Noninvasive High Frequency Oscillation Ventilation (NHFOV) post-extubation in preterm neonates as regards the efficacy and their possible complications.
Detailed description
The global definition of preterm infant by the World Health Organization is any infant born before 37 weeks of gestation. Annually, an estimated 15 million (11.1%) preterm infants are born worldwide. Preterm birth is further classified as extremely preterm (\<28 weeks), very preterm (28 to \<32 weeks), and moderate (32 to \<34 weeks) to late preterm (34 to \<37 weeks).
Prematurity has been associated with several risk factors, such as history of previous preterm birth, pregnancy induced hypertension, premature rupture of fetal membranes, multiple pregnancy, bleeding during pregnancy, history of abortion, fetal malformation, inadequate antenatal care, polyhydramnios and previous caesarean section.
Preterm neonates are at greater risk of a range of short-term and long-term morbidities. Respiratory distress syndrome (RDS) is one of the most common causes of morbidity and mortality in preterm infants. RDS is characterized by a lack of lung surfactant. Insufficient surfactant production or secretion results in higher alveolar surface tension, leading to atelectasis and impaired gas exchange. Respiratory distress typically manifests in newborns as tachypnea, intercostal retractions, nasal flaring, grunting, and cyanosis.
Invasive mechanical ventilation (IMV) increases survival in preterm infants with severe RDS. However, prolonged intubation and mechanical ventilation of preterm infants increases the risk of life-threatening complications including, ventilator induced lung injury and airway inflammation leading to bronchopulmonary dysplasia, and nosocomial pneumonia, and also increases the risk of a poor neurodevelopmental outcome. Therefore, when caring for premature infants, clinicians should focus on weaning from IMV as expeditiously as possible to noninvasive respiratory support (NRS).
There are many strategies and criteria for weaning, including evaluation of ventilatory parameters, clinical/biochemical criteria, and predictive indices of extubation that can be followed by or combined with spontaneous breathing trials or gradual withdrawal from ventilatory support.
Noninvasive respiratory support modalities include continuous positive airway pressure (CPAP), high flow nasal cannula (HFNC), noninvasive intermittent positive pressure ventilation (NIPPV), bilevel CPAP (BiPAP) and noninvasive high frequency oscillation ventilation (NHFOV).
NIPPV is a time cycled, pressure limited mode of ventilation. Conventional ventilator is used to generate two levels of pressures, namely, Peak inspiratory pressure and positive end expiratory pressure. Additionally, a backup rate is provided typically using longer inspiratory time. The main drawback of neonatal NIPPV is the lack of synchronization, which is difficult to achieve and is often unavailable.
NHFOV is the application of a bias flow generating a continuous distending positive pressure with superimposed oscillations which have a constant frequency and an active expiratory phase. NHFOV combines the advantages of NCPAP and high-frequency ventilation, making it more effective at maintaining alveolar stability, eliminating CO2, and limiting barotrauma.
The study assumed that NHFOV is more efficacious than NIPPV as regard prevention of the need for re-intubation in preterm infants with gestational age between 32 and 36 weeks and 6 days after their 1st extubation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive high frequency oscillation ventilation | Active comparator | Device: noninvasive high frequency oscillation ventilationpreterm neonates with GA of 32 to 36 weeks ready for extubation |
| Noninvasive intermittent positive pressure ventilation | Active comparator | Device: noninvasive positive pressure ventilationpreterm neonates with GA of 32 to 36 weeks ready for extubation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Preterm neonates with gestational age between 32 and 36 weeks and on mechanical ventilation ready to be extubated.
- When the case is ready for extubation , will receive at least one loading dose of caffeine citrate (20 mg/kg/dose) and daily maintenance dose of 5 mg/kg/dose.
- Blood gas analysis: PH \> 7.25 and PaCO2 ≤ 60 mmHg.
- Airway pressure (Paw) of 7 to 8 cmH2O.
- Required fraction of inspired oxygen (FiO2) ≤ 30%.
Key exclusion criteria (5 listed)
- Full term neonates.
- Preterm neonates who will not require intubation.
- Preterm neonates with one of the following criteria:
- birth weight \> 900 gms , major congenital anomalies, upper airway anomalies, neuromuscular diseases, surgical cases, intraventricular hemorrhage grade IV.
- Cases that require reintubation after more than 72 hours of extubation.
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 |
|---|---|---|
| noninvasive high frequency oscillation ventilationcases of group A extubated on NHFOV, and it will be provided by CNO, Medin device, Germany) via binasal prongs with the following parameters: * MAP of 6 cmH2O and will be titrated targeting a FiO2 ≤ 25-30%, maximum FiO2 will be 40% and target oxygen saturation will be 90-95%. * Frequency of 8 Hz and can be changed within the range of 8-12 Hz. * Amplitude of 7 cmH2O and can be titrated within the range of 7-10 cmH2O according to PaCO2. | Device | Noninvasive high frequency oscillation ventilation |
| noninvasive positive pressure ventilationNIPPV will be provided by any type of neonatal ventilator available in the unit via binasal prongs starting with the following parameters: * Positive end expiratory pressure (PEEP) of 5 cmH2O and can be titrated to 8 cmH2O according to the oxygenation . * Peak inspiratory pressure (PIP) of 15 cmH2O and can be titrated to 25 cmH2O ,according to oxygenation , PaCO2 level and the chest expansion . * FiO2 ≤ 25-30% and can be increased to 40 % maximally targeting oxygen saturation of 90-95% . * Inspiratory time of 0.40-0.50 s . * Rate of 30 bpm and can be increased to maximum 50 bpm . * Synchronization will not be applied. | Device | Noninvasive intermittent positive pressure ventilation |
Primary outcome
reintubation and the duration of respiratory support
Time frame: from the date of birth till the date of discharge from NICU or death (assessed up to 3 months)..
* The number of cases that required re-intubation and the time of failure of extubation in hours. * Duration of different types of respiratory support since birth till discharge from NICU.
1 secondary outcome
complications
Time frame: from the date of birth till the date of discharge from NICU or death (assessed up to 3 months).
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 24 Oct 2024.
- Background: PubMed 32548084Shi Y, Muniraman H, Biniwale M, Ramanathan R. A Review on Non-invasive Respiratory Support for Management of Respiratory Distress in Extremely Preterm Infants. Front Pediatr. 2020 May 28;8:270. doi: 10.3389/fped.2020.00270. eCollection 2020.
- Noninvasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with moderate-severe respiratory distress syndrome: A preliminary reportLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Heba SM El-Mahdy study chair
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive high frequency oscillation ventilation and noninvasive positive pressure ventilation in people with Noninvasive Ventilation, run by Kafrelsheikh 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 7 inclusion and 5 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 24 Oct 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?
reintubation and the duration of respiratory support (time frame: from the date of birth till the date of discharge from NICU or death (assessed up to 3 months)..). 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 NCT06620107, 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 24 Oct 2024.