Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout

Launched by CENTRE HOSPITALIER INTERCOMMUNAL CRETEIL · Mar 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help extremely premature infants breathe better using a method called Continuous Tracheal Gas Insufflation (CTGI). This technique aims to improve how these tiny babies are ventilated, which means helping them get air into their lungs when they can’t do it on their own. The goal is to find out if using CTGI can reduce the number of days these infants need other breathing support and if it helps them breathe independently sooner. Researchers will compare the health outcomes of babies using CTGI with those using standard ventilation methods to see if CTGI is more effective.

To be eligible for this trial, infants must be born between 23 and 26 weeks of gestation and be less than 8 days old. They also need to be on a ventilator to help them breathe. Parents will need to give their consent for their baby to participate. If chosen for the trial, the baby will be on the CTGI method for the duration of their stay in the neonatal intensive care unit. This trial is not yet recruiting participants, but it aims to explore a promising approach that could improve the care for the smallest and most vulnerable infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Gestational Age at birth between 23 weeks gestation + 0 days and 26 weeks gestation + 6days
• • Age between 0 and 7 days of life
• • Need for intubation and mechanical ventilation before day 8 of life
• • Availability of the Research-associated medical devices
• • Beneficiary of a social security system (in France: CMU or securité sociale)
• • Parental consent for their infant to participate in this trial
• Exclusion Criteria:
• • Known Severe Congenital Malformation (potential life-threatening malformation)
• • Known Preexisting Severe Intraventricular Haemorrhage (grade 3 or 4) and/or other brain abnormality that can alter life prognosis
• • Known Genetic Disorder (potential life-threatening malformation)
• • Preexistent mechanical ventilation for a duration of more than 12 hours
• • Participation in another interventional research trial before inclusion