CompletedNot Applicable

Nasal High Frequency in Preterm Neonates

Egypt90 participantsStarted 2021-07-15

Plain-language 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. 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.

Who can participate

Age range

1 Day – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

need for invasive mechanical ventilation

Timeframe: five days

Trial details

NCT IDNCT06687083

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-15

View on ClinicalTrials.gov More Respiratory Distress Syndrome (RDS) trials