CompletedNot Applicable

Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow

Turkey (Türkiye)34 participantsStarted 2017-01-10

Plain-language summary

Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP.

Who can participate

Age range

1 Minute – 3 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: * Does not require intubation, * Diagnosed with RDS * Premature newborns receiving surfactant therapy in the first 72 hours of life * Those whose families give written consent Exclusion Criteria: * Babies whose families do not give written consent * Newborns diagnosed with early neonatal sepsis * Newborns with inotropic requirements * Neonates with hemodynamically significant PDA * Babies of diabetic mothers * Babies with a major congenital anomaly * Newborns with hemodynamic instability, * Those requiring endotracheal intubation, * NEC (Stage 2 or higher), * Those showing ICH (Stage 2 or higher) * Babies with perfusion disorders in the first three days

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

Investigation of the effect of surfactant treatment on the p02 value in blood gases using the LISA method in premature babies with spontaneous breathing during different respiratory support.

Timeframe: 360 minutes after surfactant treatment

Trial details

NCT IDNCT06398691

SponsorHacettepe University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-23

View on ClinicalTrials.gov More Respiratory Disease trials