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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 7 months
Healthy Volunteers: f
View:

• Preterm infants at birth between 26 and 29+6 weeks gestational age with Respiratory distress syndrome requiring non invasive respiratory support

Locations
Other Locations
Italy
Ospedale dei Bambini Vittore Buzzi
RECRUITING
Milan
Contact Information
Primary
Francesco Cavigioli, MD
francesco.cavigioli@asst-fbf-sacco.it
+39263635341
Time Frame
Start Date: 2019-04-11
Estimated Completion Date: 2024-12
Participants
Target number of participants: 56
Treatments
Experimental: CPAP 8
Upon arrival of the infant on the neonatal resuscitation trolley, start the normal standard procedures required by international protocols (e.g., drying, temperature control measures, placement of pulse-oximeter sensor to the right hand or wrist, etc.). Immediately start CPAP application with mask and T-piece: the CPAP level will be set at 8 cmH2O. Perform gentle tactile stimulation if the child is not breathing in appropriately. Place the pulse-oximeter sensor on the right hand then connect it to the oxymeter previously turned on. Assess breathing and HR for 30 seconds. Perform the next step of the flow-chart of resuscitation in the delivery room according to the Neonatal Resuscitation Program guidelines. If positive pressure ventilation (PPV) is required (in case of persistent bradycardia or apnea), maintain PEEP at 8 cm H2O and an initial PIP of 25 cm H2O. The CPAP level will be reduced to 6 cm H2O after 15 minutes of life, then the recording will be discontinued.
Active_comparator: CPAP 5
Upon arrival of the infant on the neonatal resuscitation trolley, start the normal standard procedures required by international protocols (e.g., drying, temperature control measures, placement of pulse-oximeter sensor to the right hand or wrist, etc.). Immediately start CPAP application with mask and T-piece: the CPAP level will be set at 5 cmH2O. Perform gentle tactile stimulation if the child is not breathing in appropriately. Place the pulse-oximeter sensor on the right hand then connect it to the oxymeter previously turned on. Assess breathing and HR for 30 seconds. Perform the next step of the flow-chart of resuscitation in the delivery room according to the Neonatal Resuscitation Program guidelines. If positive pressure ventilation (PPV) is required (in case of persistent bradycardia or apnea), maintain PEEP at 5 cm H2O and an initial PIP of 25 cm H2O. The CPAP level will be raised to 6 cm H2O after 15 minutes of life, then the recording will be discontinued.
Related Therapeutic Areas
Sponsors
Leads: ASST Fatebenefratelli Sacco

This content was sourced from clinicaltrials.gov