Post-extubation Pressures in Preterm Neonates: A CER Study
Launched by MCMASTER CHILDREN'S HOSPITAL · Aug 9, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking into the best way to support preterm babies with breathing difficulties after they are taken off a ventilator, a process known as extubation. Specifically, the researchers want to find out what level of pressure is most effective in helping these babies breathe on their own without needing to be re-intubated. They believe that using higher pressure levels may help reduce the chances of having to put the baby back on a ventilator within the first week after extubation.
To be part of this study, babies must be born before 28 weeks of pregnancy and have received some form of mechanical ventilation. The researchers will compare the outcomes of babies receiving higher pressure support to those receiving equal or lower levels after they are extubated. Only the first time a baby is taken off the ventilator will be analyzed. Families can expect to be part of a study that aims to improve breathing support for vulnerable preterm infants, as the findings could help shape future care practices in neonatal intensive care units across Canada.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Preterm neonates GA \<28 weeks' gestation, admitted to a participating centre who received any duration of mechanical ventilation.
- Exclusion Criteria:
- • Major chromosomal/genetic/congenital abnormalities
- • Never received invasive mechanical ventilation (IMV)
- • Received IMV, but never extubated to non-invasive respiratory support (NRS)
- • Transferred to non-participating site while intubated
- • Death prior to extubation
- • Initial extubation was for withdrawal of care
- • Lack of any eligible extubation, eligible defined as ALL of the following: (i) ≥36 continuous hours on IMV; (ii) pre-extubation MAP ≤13 cmH2O; and (iii) on post-extubation NRS for ≥1 hour.
About Mcmaster Children's Hospital
McMaster Children’s Hospital is a leading pediatric healthcare institution dedicated to advancing child health through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital focuses on improving treatments and outcomes for children with various medical conditions. Leveraging its multidisciplinary expertise and state-of-the-art facilities, McMaster Children’s Hospital collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical research that adheres to the highest ethical standards. Committed to fostering a culture of inquiry and discovery, the hospital aims to translate research findings into practical applications that enhance the quality of care for pediatric patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Amit Mukerji, MD
Principal Investigator
McMaster University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported