Smaller Diaphragm Monitoring Catheter for Premature Infants with Respiratory Distress

Overseen By Laura Thomas, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Mount Sinai Hospital, Canada

Disqualifiers: Unstable infants, Congenital anomalies, Acute illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new type of catheter, the NVR 4mm Edi catheter, for premature babies who have trouble breathing and are already using a special breathing support called NAVA. The researchers want to determine if the new catheter, which is smaller and better suited for very tiny babies, works effectively without causing issues. It is specifically designed for premature infants weighing less than 1000 grams who are already on NAVA ventilation. The trial will assess whether the new catheter can be used safely and effectively for these fragile infants. As an unphased study, this trial offers a unique opportunity to contribute to research that could improve care for premature infants.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on testing a new catheter for ventilation, so medication changes might not be required.

What prior data suggests that this catheter is safe for premature infants?

Research has shown that the new NVR 4mm Edi catheter is being tested for its effectiveness in helping premature babies with breathing problems. The original, slightly larger version of this catheter has been used safely, with no reported side effects. In one study, researchers successfully placed the catheter in all tested babies, observing no negative effects.

The new catheter is smaller and designed to fit better in very small babies. Although still under testing, the original catheter's good safety record suggests that the new version will also be safe. The study involves 10 babies to ensure it functions as expected without causing any issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The NVR 4mm Edi catheter is unique because it offers a smaller design specifically tailored for premature infants with respiratory distress. Unlike standard catheters, which can be too large for these tiny patients, this new catheter aims to provide a more comfortable fit, potentially reducing complications and improving monitoring accuracy. Researchers are excited because this could lead to better respiratory support for these vulnerable infants, ensuring they receive the precise care they need right from the start.

What evidence suggests that this catheter is effective for premature infants with respiratory distress?

Research has shown that a breathing support method called neurally adjusted ventilatory assist (NAVA) can help premature babies grow and survive better. NAVA uses signals from a baby's diaphragm to adjust the breathing support they receive. This method has been linked to lower death rates and improved early care for these infants. The trial will test the new NVR 4mm Edi catheter, specially designed for the smallest babies. It captures the necessary signals with a shorter insertion, helping to avoid problems associated with larger catheters. Although this catheter features a new design, it builds on the proven benefits of NAVA in improving the health of premature infants. ^{5 6 7 8 9}

Who Is on the Research Team?

Amish Jain

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for extremely premature neonates under 1000g already on NAVA ventilation. It's not for those with congenital anomalies, without parental consent, or suffering from acute illnesses like sepsis or unstable in terms of breathing or blood circulation.

Inclusion Criteria

My newborn weighs less than 1000g and is on NAVA ventilation.

Exclusion Criteria

Parental consent not available

I have a known genetic or chromosomal condition.

I do not have any current severe infections or serious bowel and lung conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Placement of the new NVR 4 mm Edi catheter and ventilation in the NAVA mode

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after catheter placement

1 week

What Are the Treatments Tested in This Trial?

Interventions

• NVR 4mm Edi catheter

Trial Overview The study tests a new prototype Edi catheter designed for the tiniest babies on ventilators. The new catheter has sensors closer together (4mm apart) to better fit and function in these small patients compared to the standard one.

How Is the Trial Designed?

Group I: NVR 4mm Edi Catheter Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05427929

Measuring Diaphragm Electrical Activity in Neonates Using ... This is an unblinded pilot study to evaluate the performance of the new 4 mm IED. The procedures required for this evaluation include placement of the new NVR 4 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9056442/

Improved nutritional outcomes with neurally adjusted ... In conclusion, the work suggests that using NAVA ventilation in premature infants leads to an improvement in their growth trajectory, although ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11653427/

Neurally adjusted ventilatory assist improves survival, and ... Neurally adjusted ventilatory assist application was associated with lower odds of mortality, and its early application from the first few days of life helped ...

4. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02803-0

Non-invasive neurally adjusted ventilatory assist versus nasal ... A meta-analysis of nasal intermittent positive pressure ventilation in treatment of respiratory distress syndrome in premature infants.

5. mdpi.com mdpi.com/2227-9067/11/10/1184

Non-Invasive Ventilation with Neurally Adjusted Ventilatory ... Conclusions: This study found similar extubation failure rates among ELBW infants as in prior studies. However, the NAVA group had lower rates ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9502911/

Reference values for diaphragm electrical activity (Edi) in ... Edi data were successfully captured in all infants. The mean (±SD) Edi minimum was 3.02 (±0.94) μV and the mean Edi peak was 10.13 (±3.50) μV.

7. trialx.com trialx.com/clinical-trials/listings/313039/effect-of-nasal-cpap-versus-nippv-on-diaphragm-electrical-activity-edi-in-vlbw-preterm-infants/

Effect of Nasal CPAP Versus NIPPV On Diaphragm ... Our main goal in this study: To measure and compare the Edi in preterm babies requiring breathing support with CPAP or NIPPV. Inclusion Criteria (Potential ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11048199/

The Outcomes of Preterm Infants with Neonatal Respiratory ... This study aims to compare the outcomes between MIST administered with nasal continuous positive airway pressure (NCPAP) versus nasal intermittent positive ...

9. researchgate.net researchgate.net/publication/236602580_Electrical_activity_of_the_diaphragm_Edi_values_and_Edi_catheter_placement_in_non-ventilated_preterm_neonates

(PDF) Electrical activity of the diaphragm (Edi) values and ... The Edi catheter was placed successfully in 100% of these neonates. There were no adverse events noted. Conclusion: In clinically stable ...