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Search / Trial NCT03289936

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

Launched by UNIVERSITY OF TURIN, ITALY · Sep 18, 2017

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Preterm Ventilation Nasal Intermittent Positive Pressure Ventilation Synchronization Cardio Respiratory Events Newborn

ClinConnect Summary

This clinical trial is studying how two different methods of breathing support—synchronized nasal intermittent positive pressure ventilation (SNIPPV) and non-synchronized NIPPV—affect the breathing and heart function of preterm infants (those born before 32 weeks of pregnancy) who are having trouble breathing. This trial is important because it aims to find out which method helps these babies better adapt to breathing on their own, especially when they are first being treated with this non-invasive breathing support right after birth or after being taken off a breathing machine.

To participate in the trial, infants need to be born before 32 weeks of pregnancy and have never received this type of breathing support before, or they should be getting it again after being on a breathing machine. Parents will need to give their consent for their child to join. Unfortunately, babies with certain health issues, like serious brain problems, infections, or major birth defects, cannot take part in this study. If enrolled, families can expect regular monitoring of the baby's heart and breathing responses while using the two different ventilation methods. This trial is currently recruiting participants to help improve care for preterm infants with breathing difficulties.

Gender

ALL

Eligibility criteria

  • 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).

About University Of Turin, Italy

The University of Turin, located in Italy, is a prestigious academic institution renowned for its commitment to research and innovation in the medical field. As a clinical trial sponsor, the university leverages its extensive expertise and resources to advance scientific knowledge and improve patient outcomes. Collaborating with a network of healthcare professionals and researchers, the University of Turin conducts rigorous clinical trials that adhere to the highest ethical and regulatory standards. Its focus on translational research ensures that findings contribute to the development of effective therapies and healthcare solutions, enhancing the overall well-being of diverse populations.

Locations

Torino, (To), Italy

Torino, , Italy

Patients applied

0 patients applied

Trial Officials

Francesco Cresi, PhD

Study Chair

Città della Salute e della Scienza - Ospedale S.Anna - University of Turin

Alessandra Coscia, Prof.

Study Director

Città della Salute e della Scienza - Ospedale S.Anna - University of Turin

Elena Maggiora, MD

Principal Investigator

Città della Salute e della Scienza - Ospedale S.Anna - University of Turin

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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