NCT05589831 Respiratory Support and Brain Health in Preterm Infants
| NCT ID | NCT05589831 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mount Sinai Hospital, Canada |
| Condition | Sleep |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-07-04 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-07-04 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Premature babies often require breathing support during their neonatal intensive care unit stay. This is because their lungs are not fully developed to perform the work of breathing on their own. Although breathing support can be provided via a breathing tube, it is preferable to provide breathing support non-invasively from a breathing machine which is then connected to a mask or prongs placed on the baby's nose. In premature babies born under 32 weeks gestation, a commonly used mode of non-invasive breathing support is called Non-Invasive Positive Pressure Ventilation (NIPPV). In this mode, the breathing machine provides 2 levels of support: one is the constant distending pressure to keep the lungs open and the other provides additional 'breaths' on top of that distending pressure. This is to mimic regular breathing. These breaths are set at a fixed rate and pressure. Although NIPPV protects the lungs from injury caused by a breathing tube, the breaths are not in sync with the baby's own breathing effort. Another mode of non-invasive breathing support recently being used in premature infants called Neurally Adjusted Ventilatory Assist (NAVA). When NAVA is provided non-invasively using a mask or prongs similar to NIPPV, it is called Non-invasive NAVA (NIV-NAVA). During NIV-NAVA a special feeding tube is used that detects the baby's own breathing movement from the electrical signal of the baby's diaphragm and feeds back to the machine which then provides a 'top-up' to the baby's own breath. This top-up breath also provides only as much pressure as the baby needs on top on their own breathing effort. Therefore, this is thought to be in sync with the baby's own breathing effort. However, it is not known if this mode of ventilation leads to improved sleep, improved brain oxygen levels, reduced discomfort and improved functioning of the diaphragm. The investigators aim to examine these indices in this research project.
Eligibility Criteria
Inclusion Criteria: * Preterm infants born between 22+0 and 31+6 weeks' GA * Weight \> 500 g at the time of approach for consent * A minimum of 3 days of age * Clinically stable for \> 24 hours while receiving NIPPV or NIV-NAVA Clinical stability will be defined as meeting all the following criteria for a 24 hour period prior to recruitment: 1. differences in maximum and minimum fractions of inspired oxygen (FiO2) of \<20% 2. differences in maximum and minimum MAP \<4 cm H2O 3. no active infection 4. no hypotension 5. no use of cardioactive medications or medical therapy for patent ductus arteriosus. Exclusion Criteria: * Infants with IVH of grade 3 or 4 * Birth weight \< 3rd percentile * Genetic or congenital abnormalities
Contact & Investigator
Poorva Deshpande
PRINCIPAL INVESTIGATOR
MOUNT SINAI HOSPITAL
Frequently Asked Questions
Who can join the NCT05589831 clinical trial?
This trial is open to participants of all sexes, aged 3 Days or older, studying Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05589831 currently recruiting?
Yes, NCT05589831 is actively recruiting participants. Contact the research team at poorva.deshpande@sinaihealth.ca for enrollment information.
Where is the NCT05589831 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05589831 clinical trial?
NCT05589831 is sponsored by Mount Sinai Hospital, Canada. The principal investigator is Poorva Deshpande at MOUNT SINAI HOSPITAL. The trial plans to enroll 50 participants.