An interventional study of Maquet [servo-n] and Drager , SLE 5000, SLE 6000 in Preterm , Respiratory Distress Syndrome and Preterm Respiratory Distress Syndrome, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 1 Day to 1 Month. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Ain Shams University · Not applicable, Interventional, and Diagnostic
A randomized controlled clinical trial evaluates the efficacy of NAVA in comparison with conventional ventilation (SIMV) in preterm neonates with respiratory distress syndrome.
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 .
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2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 30 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 to NAVA
Examples are the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After documenting parental consent, preterm neonates with respiratoryd by insufficiency randomly ventilated on NAVA will be assessed by transcranial Doppler ultrasonographic examination and echocardiography.
Device: Maquet [servo-n]
After documenting parental consent, preterm neonates with respiratoryd by insufficiency randomly ventilated on SIMV will be assessed by transcranial Doppler ultrasonographic examination and echocardiography.
Device: Drager , SLE 5000, SLE 6000
ventilator settings will be recorded such as: NAVA level , Edi peak , peep, apnea time
ventilator settings will be recorded such as peep , PIP , Fio2
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.
Time frame: baseline and after 24 hours from enrollment in the study
Transcranial ultrasonography Doppler
applied to the middle cerebral artery to provide an estimate of cerebral blood flow performed by a specialized pediatric radiologist .
Time frame: baseline and after 24 hours from enrollment in the study
Duration of admission
To document total number of days of admission
Time frame: up to 8 weeks or till patient discharged or die which comes first
Mortality rate
To document incidence of mortality during hospitalization
Time frame: up to 8 weeks or till patient death which comes first
Incidence of feeding intolerance
Percentage of Patients who developed feeding intolerance
Time frame: 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
Time frame: 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
Time frame: upon NICU admission and one hour after enrollment in the study .
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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