Preterm , Respiratory Distress SyndromeNCT07926009
NAVA Use in Preterm Neonates With Respiratory Distress Syndrome
A study testing Maquet [servo-n] and Drager , SLE 5000, SLE 6000 in people with Preterm , Respiratory Distress Syndrome and Preterm Respiratory Distress Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial summary
A randomized controlled clinical trial evaluates the efficacy of NAVA in comparison with conventional ventilation (SIMV) in preterm neonates with respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Preterm , Respiratory Distress Syndrome, Preterm Respiratory Distress Syndrome
- What is being tested?
- Maquet [servo-n] and Drager , SLE 5000, SLE 6000
- 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
- 24 Jan 2026to Jan 2028
- 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 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≤ 34 weeks.
- Neonates that have RDS according to clinical and radiological findings
- Neonates requiring invasive mechanical ventilation.
Who cannot join
- 1) Preterm neonates that have respiratory distress due to causes other than respiratory distress syndrome including transient tachypnea of new born , congenital pneumonia and sepsis. 2)Central and peripheral conditions that limit the respiratory drive, as well as diaphragmatic anatomical defects in patients with an intact respiratory drive, comprise the contraindications to NAVA
- Examples are the following:
- Central disorder: paralytic drug use, respiratory drive suppression due to heavy sedation or brain injury.
- Peripheral disorder: phrenic nerve injury, paralytic agent administration.
- Structural (anatomical) disorder: esophageal atresia, diaphragmatic hernia. 3) Cardiac patients including aortic coarctation , double outlet right ventricle (DORV), Tetralogy of Fallot and Transposition of the great arteries (TGA). 4) Surgical patients including gastroschisis , omphalocele , tracheoesophageal fistula and congenital diaphragmatic hernia (CDH).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rania Ali El-Farrash contact
Egypt1 site, 1 recruiting
- Recruiting
Neonatal Intensive Care Units (NICUs), Ain Shams University
Cairo, Abbasia, 11517
About this study
Official title: Neurally Adjusted Ventilatory Assist [NAVA] Versus Conventional Ventilation in Preterm Neonates With Respiratory Distress Syndrome
A randomized controlled clinical trial evaluates the efficacy of NAVA in comparison with conventional ventilation (SIMV) in preterm neonates with respiratory distress syndrome.
Read the detailed description
Numerous methods for ventilating patients are available in both invasive and noninvasive modes. However, patient-ventilator asynchrony has been a persistent problem .
Neurally adjusted ventilatory assist (NAVA) improves patient-ventilator synchrony in preterm infants, leading to reduced work of breathing, lower peak inspiratory pressures (PIP), and decreased oxygen requirements compared to conventional ventilation . This improved synchrony results in better oxygenation and ventilation, potentially reducing the risk of lung injury and other complications associated with mechanical ventilation in preterm neonates . . NAVA is a mechanical ventilation modality in which the ventilator assists the patient breath in proportion to and in synchrony with the electrical activity of the diaphragm (EAdi) .EAdi is a fast and accurate reflection of phrenic nerve activity arising from central respiratory centers.
During NAVA use, a nasogastric or orogastric tube with electrodes is placed in the patient to detect changes in the diaphragm's electrical activity (Edi) more than 60 times per second . The diaphragm contracts as the phrenic nerves deliver the signal to breathe. The ventilator measures the strength of this activity and provides an appropriately sized breath based on the patient's own effort .
As synchronization in NAVA is independent of pressure or flow trigger and independent of leaks, NAVA has a strong potential to increase invasive ventilation efficiency .
Patient-ventilator asynchrony occurs when the ventilator fails to detect the patient's breath or detects it too late in the breathing cycle, leading to complications that include increased sedation, discomfort, and possibly higher morbidity and mortality .
With NAVA, the patient is actually controlling the trigger, delivery and cycling of every breath. The ventilator becomes completely synchronous with the patient avoiding the undesirable outcomes of patient-ventilator asynchrony. Since the Edi is a reflection of neural respiratory output, ventilator breath delivery is in synchrony with neural control of ventilation .
.
- Being tested
- Maquet [servo-n], Drager , SLE 5000, SLE 6000
- Keywords
- NAVA , preterm , respiratory distress syndrome
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maquet [servo-n]Device
ventilator settings will be recorded such as: NAVA level , Edi peak , peep, apnea time
Drager , SLE 5000, SLE 6000Device
ventilator settings will be recorded such as peep , PIP , Fio2
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Neurally Adjusted Ventilatory Assist [NAVA] . | Experimental | After documenting parental consent, preterm neonates with respiratoryd by insufficiency randomly ventilated on NAVA will be assessed by transcranial Doppler ultrasonographic examination and echocardiography. Receives: Device: Maquet [servo-n] |
| Active Comparator: Synchronized Intermittent Mandatory Ventilation (SIMV) | Active comparator | After documenting parental consent, preterm neonates with respiratoryd by insufficiency randomly ventilated on SIMV will be assessed by transcranial Doppler ultrasonographic examination and echocardiography. Receives: Device: Drager , SLE 5000, SLE 6000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiography
to assess any structural cardiac anomalies, the patency of ductus arteriosus, right ventricular output (RVO), left ventricular output (LVO), and superior vena cava (SVC) flow, ejection fraction (EF) and pulmonary pressure performed by a specialized echocardiographist.
Measured: baseline and after 24 hours from enrollment in the study
Secondary outcomes (6)
Transcranial ultrasonography Doppler
applied to the middle cerebral artery to provide an estimate of cerebral blood flow performed by a specialized pediatric radiologist .
Measured: baseline and after 24 hours from enrollment in the study
Duration of admission
To document total number of days of admission
Measured: up to 8 weeks or till patient discharged or die which comes first
Mortality rate
To document incidence of mortality during hospitalization
Measured: up to 8 weeks or till patient death which comes first
Incidence of feeding intolerance
Percentage of Patients who developed feeding intolerance
Measured: up to 8 weeks or till patient discharged or die which comes first
Days to reach full intake
Number of days needed by each patient to reach full intake
Measured: up to 8 weeks or till patient discharged or die which comes first
Chest x ray change
Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree
Measured: upon NICU admission and one hour after enrollment in the study .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start24 Jan 2026
- Primary completionOct 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm , Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Ali El-Farrash, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07926009
- Sponsor's protocol ID
- NAVA use in preterm neonates
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 9 Nov 2026
- 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 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurally Adjusted Ventilatory Assist [NAVA] Versus Conventional Ventilation in Preterm Neonates With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07926009
- Acronym / sponsor ID
- NAVA use in preterm neonates
- Keywords
- NAVA , preterm , respiratory distress syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Jan 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 9 Nov 2026 (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.
A randomized controlled clinical trial evaluates the efficacy of NAVA in comparison with conventional ventilation (SIMV) in preterm neonates with respiratory distress syndrome.
Detailed description
Numerous methods for ventilating patients are available in both invasive and noninvasive modes. However, patient-ventilator asynchrony has been a persistent problem .
Neurally adjusted ventilatory assist (NAVA) improves patient-ventilator synchrony in preterm infants, leading to reduced work of breathing, lower peak inspiratory pressures (PIP), and decreased oxygen requirements compared to conventional ventilation . This improved synchrony results in better oxygenation and ventilation, potentially reducing the risk of lung injury and other complications associated with mechanical ventilation in preterm neonates . . NAVA is a mechanical ventilation modality in which the ventilator assists the patient breath in proportion to and in synchrony with the electrical activity of the diaphragm (EAdi) .EAdi is a fast and accurate reflection of phrenic nerve activity arising from central respiratory centers.
During NAVA use, a nasogastric or orogastric tube with electrodes is placed in the patient to detect changes in the diaphragm's electrical activity (Edi) more than 60 times per second . The diaphragm contracts as the phrenic nerves deliver the signal to breathe. The ventilator measures the strength of this activity and provides an appropriately sized breath based on the patient's own effort .
As synchronization in NAVA is independent of pressure or flow trigger and independent of leaks, NAVA has a strong potential to increase invasive ventilation efficiency .
Patient-ventilator asynchrony occurs when the ventilator fails to detect the patient's breath or detects it too late in the breathing cycle, leading to complications that include increased sedation, discomfort, and possibly higher morbidity and mortality .
With NAVA, the patient is actually controlling the trigger, delivery and cycling of every breath. The ventilator becomes completely synchronous with the patient avoiding the undesirable outcomes of patient-ventilator asynchrony. Since the Edi is a reflection of neural respiratory output, ventilator breath delivery is in synchrony with neural control of ventilation .
.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Neurally Adjusted Ventilatory Assist [NAVA] . | Experimental | Device: Maquet [servo-n]After documenting parental consent, preterm neonates with respiratoryd by insufficiency randomly ventilated on NAVA will be assessed by transcranial Doppler ultrasonographic examination and echocardiography. |
| Active Comparator: Synchronized Intermittent Mandatory Ventilation (SIMV) | Active comparator | Device: Drager , SLE 5000, SLE 6000After documenting parental consent, preterm neonates with respiratoryd by insufficiency randomly ventilated on SIMV will be assessed by transcranial Doppler ultrasonographic examination and echocardiography. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age ≤ 34 weeks.
- Neonates that have RDS according to clinical and radiological findings
- Neonates requiring invasive mechanical ventilation.
Key exclusion criteria (5 listed)
- 1) Preterm neonates that have respiratory distress due to causes other than respiratory distress syndrome including transient tachypnea of new born , congenital pneumonia and sepsis. 2)Central and peripheral conditions that limit the respiratory drive, as well as diaphragmatic anatomical defects in patients with an intact respiratory drive, comprise the contraindications to NAVA
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 |
|---|---|---|
| Maquet [servo-n]ventilator settings will be recorded such as: NAVA level , Edi peak , peep, apnea time | Device | Experimental: Neurally Adjusted Ventilatory Assist [NAVA] . |
| Drager , SLE 5000, SLE 6000ventilator settings will be recorded such as peep , PIP , Fio2 | Device | Active Comparator: Synchronized Intermittent Mandatory Ventilation (SIMV) |
Primary outcome
Echocardiography
Time frame: baseline and after 24 hours from enrollment in the study
to assess any structural cardiac anomalies, the patency of ductus arteriosus, right ventricular output (RVO), left ventricular output (LVO), and superior vena cava (SVC) flow, ejection fraction (EF) and pulmonary pressure performed by a specialized echocardiographist.
6 secondary outcomes
Transcranial ultrasonography Doppler
Time frame: baseline and after 24 hours from enrollment in the study
Duration of admission
Time frame: up to 8 weeks or till patient discharged or die which comes first
Mortality rate
Time frame: up to 8 weeks or till patient death which comes first
Incidence of feeding intolerance
Time frame: up to 8 weeks or till patient discharged or die which comes first
Days to reach full intake
Time frame: up to 8 weeks or till patient discharged or die which comes first
Chest x ray change
Time frame: upon NICU admission and one hour after enrollment in the study .
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 9 Nov 2026.
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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.
Rania Ali El-Farrash contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maquet [servo-n] and Drager , SLE 5000, SLE 6000 in people with Preterm , Respiratory Distress Syndrome and Preterm Respiratory Distress Syndrome, 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 3 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: looking for participants now, as of the sponsor's last update on 9 Nov 2026. 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 Rania Ali El-Farrash (+201222208550), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiography (time frame: baseline and after 24 hours from enrollment in the study). 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 9 Nov 2026.