UnknownNot Applicable

Short Term Effects of Synchronized vs. Non-synchronized NIPPV in Preterm Infants.

Italy30 participantsStarted 2020-11-16

Plain-language summary

Comparing the cardio-respiratory adaptation and differences to non invasive ventilation techniques, nasal intermittent positive pressure ventilation (NIPPV) non synchronized vs synchronized (SNIPPV) in preterm newborns (gestational age at birth \< 32 weeks) at their first approach to non invasive ventilation as first intention (soon after birth) or after extubation.

Who can participate

Age range

32 Weeks

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 at birth \<32 weeks * First approach to NIV ventilation (primary or after extubation) * Parent's informed consent Exclusion Criteria: * Neurological (including IVH \> 2° grade) or surgical diseases * Sepsis (clinical or laboratory confirmed) * Chromosomal or genetic abnormalities * Major malformations and congenital anomalies * Cardiac problems (including hemodynamically significant PDA) * Contraindication to NIV (i.e. nasal trauma and gastrointestinal surgery within the previous 7 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

Frequency of episodes of desaturation

Timeframe: 3 hours of NIPPV vs 3 hours SNIPPV

Trial details

NCT IDNCT03289936

SponsorUniversity of Turin, Italy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Francesco Cresi, PhD, MD

+39 11 3135781 francesco.cresi@unito.it

View on ClinicalTrials.gov More Newborn Respiratory Distress trials