An interventional study of Superimposed sigh breaths and High frequency ventilation in Preterm, Respiratory Distress Syndrome in Premature Infant and Recruitment, sponsored by Alexandria University. Not yet recruiting. Open to participants aged 5 Minutes to 6 Hours. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
Among 10 studies in Premature Birth by Alexandria University — 5 open to participants now, 5 under way, none of them phase 3. Premature Birth · Alexandria University.
Among the 10 studies in Premature Birth by Alexandria University, this one is the 4th largest by planned enrollment, is the only one that started in 2026, is one of 8 with no phase, and was the 10th registered.
2,553 studies on the registry are indexed under Premature Birth; 502 are open to participants now.
Browse Premature Birth studies →5 of the 10 studies in Premature Birth by Alexandria University are open now, in 1 country. Recruiting first, the newest first:
Alexandria University · Sites in Egypt
Ages 3 days–1 mo
Alexandria University · Sites in Egypt
Ages 1 min–2 min · Healthy volunteers
Alexandria University · Sites in Egypt
Ages 1 hrs–24 hrs · Healthy volunteers
Alexandria University · Sites in Egypt
Ages 1 hrs–3 days
By country, each count listing its studies:
Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger; 241 take children under 18; 105 take healthy volunteers.
This study: 5 Minutes to 6 Hours · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2021; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 84 across 1,669 interventional studies indexed under Premature Birth.
Median enrollment 100 across the 10 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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Alexandria University is the lead sponsor of 606 studies on the registry; 141 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
1 of the studies in Premature Birth by Alexandria University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07896824Alexandria UniversityThe Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants | 2027-11-15 |
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Among the 10 studies in Premature Birth by Alexandria University, from their registry updates:
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To evaluate the effectiveness of early lung recruitment using high-frequency oscillatory ventilation (HFOV) alone versus HFOV with superimposed sigh breaths in moderate-to-late preterm infants requiring invasive respiratory support at Alexandria University Children's Hospital.
Preterm neonates will be eligible for inclusion in the study if they meet all of the following criteria:
Clinical and/or radiological evidence of diffuse lung disease consistent with respiratory distress syndrome or early diffuse atelectasis, evidenced by at least one of the following:
Exclusion Criteria:
HFOV will be delivered with the following initial settings: * Frequency: 10-15 Hz, starting at 10 Hz. * I:E ratio: 1:1. * Amplitude: adjusted to achieve adequate chest vibration and target PaCO2. * Mean airway pressure (MAP): adjusted according to the recruitment protocol and subsequent maintenance pressure strategy. * Carbon dioxide control will be achieved by adjusting oscillatory amplitude.
Other: High frequency ventilation
In addition to HFOV settings identical to Group A, intermittent sigh breaths will be applied using Dräger Babylog® VN600 neonatal ventilator.The sigh settings in the present protocol will be as follows: * Sigh breath rate: incremental increase starting from 5 sighs/ min. * Inspiratory time: 0.6 * Peak inspiratory pressure (PIP): incremental increase starting from 7 cm.H₂O above the preset MAP * Sigh breaths will be progressively reduced and discontinued once lung recruitment is stable and adequate oxygenation is maintained at the assigned maintenance pressure.
Other: Superimposed sigh breaths · Other: High frequency ventilation
* Sigh breath rate: incremental increase starting from 5 sighs/ min. * Inspiratory time: 0.6 * Peak inspiratory pressure (PIP): incremental increase starting from 7 cm.H₂O above the preset MAP * Sigh breaths will be progressively reduced and discontinued once lung recruitment is stable and adequate oxygenation is maintained at the assigned maintenance pressure.
HFOV will be delivered with the following initial settings: * Frequency: 10-15 Hz, starting at 10 Hz. * I:E ratio: 1:1. * Amplitude: adjusted to achieve adequate chest vibration and target PaCO₂. * MAP: adjusted according to the recruitment protocol and subsequent maintenance pressure strategy. * Carbon dioxide control will be achieved by adjusting oscillatory amplitude.
Oxygenation evaluation
To determine whether HFOV with superimposed sigh breaths improves early lung recruitment compared to HFOV alone, as assessed by the oxygenation saturation index (OSI) . OSI is calculated by MAP.FIO2.100/SPaO2. MAP = Mean Airway Pressure (cmH\_2O) FiO₂ = Fraction of Inspired Oxygen (expressed as a decimal, e.g., 0.21 to 1.0) SpO₂ = Pulse oximetry oxygen saturation (%) . Normal / Mild Respiratory Distress: OSI \< 4. Moderate Respiratory Failure: OSI 4.0 to 8.0 Severe Respiratory Failure: OSI \> 8.0 to 10.0.
Time frame: first 24 hours of life
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 744 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 12 months is below that.
Counting every sponsor, half of 762 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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