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Search / Trial NCT06123845

Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM

Launched by ASST FATEBENEFRATELLI SACCO · Nov 3, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Rds Ncpap Peep Lung Recruitment Delivery Room Resuscitation

ClinConnect Summary

This clinical trial is studying the best way to help premature infants who have breathing difficulties right after birth, specifically those with a condition called Respiratory Distress Syndrome (RDS). The researchers want to see if using a special breathing support technique called CPAP (Continuous Positive Airway Pressure) at a higher pressure of 8 cmH2O can help improve the infants' lung function better than a lower pressure of 5 cmH2O. They are looking at whether better lung function in the early minutes of life can lead to healthier outcomes for these babies in the long run.

To be part of this trial, infants need to be born between 26 and 29 weeks of pregnancy and have RDS requiring noninvasive help with their breathing. Infants with certain birth defects will not be eligible. If a baby joins the study, their doctors will closely monitor how well they breathe with the different pressure levels during their first moments after birth. This research aims to find the best care for these vulnerable newborns to give them a stronger start in life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Preterm infants at birth between 26 and 29+6 weeks gestational age with Respiratory distress syndrome requiring non invasive respiratory support
  • Exclusion Criteria:
  • Congenital anomalies

About Asst Fatebenefratelli Sacco

Asst Fatebenefratelli Sacco is a prominent healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a strong commitment to ethical standards and patient safety, the organization collaborates with leading researchers and healthcare professionals to explore new therapies and treatment options across various medical fields. Asst Fatebenefratelli Sacco leverages its extensive expertise and state-of-the-art facilities to contribute to the global body of medical knowledge, ultimately aiming to enhance the quality of care for patients both locally and beyond.

Locations

Milano, Lombardy, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported