NeoVest for Neonatal Respiratory Distress Syndrome

(Neovest Trial)

Overseen By Douglas Campbell, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Must not be taking: Inotropic medications

Disqualifiers: Apnoea, Bradycardia, Genetic conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 22 minutes

20 Participants Needed

Trial Summary

Do I have to stop my baby's current medications for the trial?

The trial protocol does not specify whether infants need to stop their current medications. However, infants requiring inotropic medications (drugs that affect heart contraction) are excluded, which might imply some restrictions.

What data supports the effectiveness of the treatment NeoVest for Neonatal Respiratory Distress Syndrome?

Research shows that various noninvasive ventilation methods, like nasal intermittent positive pressure ventilation (NIPPV) and nasal continuous positive airway pressure (NCPAP), are effective in treating neonatal respiratory distress syndrome by helping infants breathe more easily without invasive procedures. ^{1 2 3 4 5}

Is NeoVest safe for use in humans?

There is no specific safety data available for NeoVest, but general safety concerns exist for neonatal treatments due to the lack of drug trials in this population, which can lead to risks of drug toxicity and ineffective treatment. ^{1 6 7 8 9}

How is the treatment NeoVest different from other treatments for neonatal respiratory distress syndrome?

NeoVest is unique because it likely involves a novel approach to noninvasive ventilation, potentially using advanced nasal cannula technology or innovative ventilation strategies, which may differ from traditional methods like nasal high-frequency ventilation or nasal intermittent positive pressure ventilation. ^{1 10 11 12 13}

What is the purpose of this trial?

This trial tests the NeoVest, a wearable vest that helps infants with breathing problems by gently pulling on their abdomen. It is designed for premature and full-term infants who need breathing support. The vest assists breathing and synchronizes with the baby's natural breaths.

Research Team

Douglas Campbell, MD

Principal Investigator

Unity Health Toronto

Eligibility Criteria

This trial is for babies over 1.5kg who are stable but have breathing difficulties like transient tachypnea or respiratory distress syndrome, and have been on nasal CPAP for at least 6 hours within their first two weeks of life. Babies with high oxygen needs, upper airway distress, significant apnoea/bradycardia, unstable blood pressure, recent extubation, certain catheters in place or allergies to silicone can't participate.

Inclusion Criteria

I am within the first two weeks of my life.

This criterion refers to 20 babies who are currently in the Neonatal Intensive Care Unit at St. Michael's Hospital.

You weighed more than 1.5 kilograms at birth.

Exclusion Criteria

My infant has a visible belly or chest abnormality.

My infant has had serious breathing pauses or slow heart rate recently.

My infant has an umbilical catheter.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive negative pressure ventilation using the NeoVest device, synchronized to the infant's respiratory demand

22 minutes

Single session

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NeoVest

Trial Overview The study tests the NeoVest device—a wearable vest that applies gentle negative pressure on a baby's abdomen to help with breathing. It aims to show this method is feasible and synchronized with the infant's own breaths. The data will support applications for larger studies.

Participant Groups

Group I: NeoVest Experimental Treatment 1 Intervention

Negative pressure ventilation using NeoVest

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Findings from Research

In a study of 100 neonates with neonatal respiratory distress syndrome (NRDS), nasal intermittent positive pressure ventilation (NIPPV) was found to be more effective than nasal continuous positive airway pressure (NCPAP) in reducing CO2 retention and improving oxygenation within the first 6 hours of treatment.

NIPPV also resulted in significantly lower rates of second endotracheal intubation and reduced the need for additional pulmonary surfactant, indicating its potential to improve overall respiratory support outcomes in neonates with NRDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical application of nasal intermittent positive pressure ventilation in initial treatment of neonatal respiratory distress syndrome]. Fu, CH., Xia, SW.[2014]

A new NICU-focused trigger tool was developed and tested, revealing a high incidence of adverse events in hospitalized children, with 554 unique adverse events identified across 749 charts, averaging 0.74 events per patient.

The study found that 56% of these adverse events were preventable, highlighting the need for improved safety measures, as only 8% were reported through traditional hospital reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Sharek, PJ., Horbar, JD., Mason, W., et al.[2021]

References

1. China pubmed.ncbi.nlm.nih.gov

[Clinical application of nasal intermittent positive pressure ventilation in initial treatment of neonatal respiratory distress syndrome]. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Nasal continuous positive airway pressure (NCPAP) or noninvasive neurally adjusted ventilatory assist (NIV-NAVA) for preterm infants with respiratory distress after birth: A randomized controlled trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Noninvasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with moderate-severe respiratory distress syndrome: A preliminary report. [2022]

4. Pakistan pubmed.ncbi.nlm.nih.gov

Clinical effects of pulmonary surfactant in combination with nasal continuous positive airway pressure therapy on neonatal respiratory distress syndrome. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Nasal High-Flow Therapy as Primary Respiratory Support for Preterm Infants without the Need for Rescue with Nasal Continuous Positive Airway Pressure. [2019]

6. Colombia pubmed.ncbi.nlm.nih.gov

[Adverse drug reactions in neonates hospitalized in neonatal intensive care units in Barranquilla, Colombia]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Inter-rater reliability of the neonatal adverse event severity scale using real-world Neonatal clinical trial data. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Issues, challenges, and the way forward in conducting clinical trials among neonates: investigators' perspective. [2021]

10. France pubmed.ncbi.nlm.nih.gov

Comparison of three different noninvasive ventilation strategies as initial respiratory support in very low birth weight infants with respiratory distress syndrome: A retrospective study. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Nasal high frequency ventilation in neonates with moderate respiratory insufficiency. [2019]

12. China pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of nasal high-frequency ventilation in treatment of neonatal respiratory distress syndrome: a Meta analysis]. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a nasal cannula in noninvasive ventilation using a lung simulator. [2019]