Respiratory Distress Syndrome in Premature Infant Clinical Trial
— PHILODENDROOMOfficial title:
Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM
The aim of this randomized pilot clinical trial of preterm infants requiring noninvasive respiratory support for respiratory distress syndrome (RDS) at birth is to improve short-term respiratory outcomes. The main question it aims to answer is: - Can a CPAP (or a PEEP if ventilation is needed) administered with a face mask and a T-piece at a level of 8 cmH2O improve lung recruitment in the delivery room when compared to administration of a level of 5 cmH2O in a control group? - Secondly, can improved lung recruitment in the first few minutes of life provide long-term benefits to the premature infant? The participants will be premature infants between 26 and 29+6 weeks gestational age.
Status | Recruiting |
Enrollment | 56 |
Est. completion date | December 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 26 Weeks to 30 Weeks |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale dei Bambini Vittore Buzzi | Milano | Lombardy |
Lead Sponsor | Collaborator |
---|---|
ASST Fatebenefratelli Sacco |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxygen saturation/Inspired Oxygen fraction (SpO2/FiO2) | Oxygen saturation / Inspired Oxygen fraction ratio | From randomization assessed every minute up to 15 minutes of life | |
Secondary | Exhaled tidal volumes (Vte) | Exhaled tidal volumes | From randomization assessed every minute up to 15 minutes of life | |
Secondary | HR | Heart rate | From randomization assessed every minute up to 15 minutes of life | |
Secondary | SpO2 | Oxygen peripheral saturation | From randomization assessed every minute up to 15 minutes of life | |
Secondary | PPV | Need for positive pressure ventilation | From randomization up to 15 minutes of life | |
Secondary | ET | occurrence of Endotracheal intubation in the delivery room | From randomization up to 15 minutes of life | |
Secondary | MV | Need for Mechanical ventilation | From randomization up to 72 hours of life | |
Secondary | Surf | Need for Surfactant administration | From randomization up to 72 hours of life | |
Secondary | PNX | occurrence of Pneumothorax | From randomization up to 72 hours of life | |
Secondary | PIE | occurrence of Pulmonary interstitial emphysema | From randomization up to 72 hours of life | |
Secondary | IVH | occurrence of Intraventricular hemorrhage any grade of severity | From randomization up to 72 hours of life | |
Secondary | BPD | Clinical diagnosis of Bronchopulmonary dysplasia | assessed at 36 weeks gestational age (GA) | |
Secondary | Death | Mortality for any cause | From date of randomization until the date of death from any cause, assessed up to 40 weeks gestational age (GA) |
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