Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05589831
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2022-10-05
Brief Title:
Respiratory Support and Brain Health in Preterm Infants
Sponsor:
Mount Sinai Hospital Canada
Organization:
Mount Sinai Hospital Canada
Study Overview
Official Title:
Respiratory Support and Brain Health in Preterm Infants A Prospective Crossover Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 babys 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 babys 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 babys own breathing movement from the electrical signal of the babys diaphragm and feeds back to the machine which then provides a top-up to the babys 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 babys 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
Detailed Description:
Rationale It is imperative to find the optimal method of supporting not only lung development but also brain development during this critical period of brain growth and development NIV-NAVA is a more physiologically compatible method of supporting respiration The investigators hypothesize that this compatibility may increase comfort and restful periods compared to standard NIPPV and thus may be more neuroprotective
Objective and outcomes assessed The objective is to compare sleep-wake cycling cerebral oxygenation heart rate variability and diaphragm function during standard NIPPV and NIV-NAVA modes in preterm neonates born at 32 weeks gestation who are stable on NIPPV or NIV-NAVA for at least 24 hours and are a minimum of 3 days old
Objective and outcomes assessed The objective is to compare sleep-wake cycling cerebral oxygenation heart rate variability and diaphragm function during standard NIPPV and NIV-NAVA modes in preterm neonates born at 32 weeks gestation who are stable on NIPPV or NIV-NAVA for at least 24 hours and are a minimum of 3 days old
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None