Mask Ventilation Techniques for Neonatal Respiratory Distress Syndrome

(VOLT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Georg Schmölzer, MD, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alberta

Disqualifiers: Congenital abnormalities, Congenital heart disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room. Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment for neonatal respiratory distress syndrome?

Research suggests that volume-targeted ventilation (VTV) is more effective than pressure-limited ventilation (PLV) for preterm infants, as it helps reduce lung damage and stabilizes breathing by maintaining a consistent air volume. ^{1 2 3 4 5}

How does the treatment of volume-targeted ventilation differ from other treatments for neonatal respiratory distress syndrome?

Volume-targeted ventilation (VTV) is unique because it aims to deliver a consistent amount of air to the lungs, reducing the risk of lung damage and stabilizing breathing, unlike pressure-limited ventilation (PLV) which uses a fixed pressure and can lead to lung overdistension. ^{1 2 3 4 6}

Research Team

Georg Schmölzer, MD, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for preterm infants born between 23-28 weeks' gestation who need help breathing at birth. It's open to ELGAN babies (Extremely Low Gestational Age Newborns). Babies with congenital abnormalities affecting breathing, certain heart diseases, or without parental consent are excluded.

Inclusion Criteria

Inclusion criteria are pragmatic to enable the inclusion of ELGAN infants (Extremely Low Gestational Age Newborns)

My baby was born between 23-28 weeks and needed help breathing.

Exclusion Criteria

My parents did not consent to my participation in this study.

My infant does not have any birth defects affecting breathing or heart conditions needing early surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Preterm infants are randomized to receive either pressure guided or volume targeted ventilation during respiratory support in the delivery room

Immediate (during delivery room stay)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Treatment Details

Interventions

• Pressure targeted ventilation (Ventilation)
• Volume targeted ventilation (Ventilation)

Trial Overview The study compares two methods of helping premature babies breathe right after birth: volume targeted ventilation and pressure targeted ventilation. Infants will be randomly assigned to one of these two approaches in the delivery room.

Participant Groups

Group I: Volume Targeted Ventilation Experimental Treatment 1 Intervention

Positive pressure ventilation will be provided using a set tidal volume

Group II: Pressure guided Ventilation Active Control 1 Intervention

Positive pressure ventilation will be provided using a set peak inflation pressure

Pressure targeted ventilation is already approved in Canada for the following indications:

Approved in Canada as Pressure-Limited Ventilation for:

• Respiratory distress syndrome (RDS)
• Bronchopulmonary dysplasia (BPD)
• Neonatal respiratory failure

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

Findings from Research

In a study of 100 preterm infants, those receiving volume-targeted ventilation (VTV) had a significantly lower mortality rate and reduced hypercarbia compared to those on pressure-limited ventilation (PLV).

VTV also resulted in a significant decrease in the combined outcome of death or bronchopulmonary dysplasia (BPD), indicating it may be a safer and more effective ventilation strategy for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volume-targeted versus pressure-limited ventilation for preterm infants. Chen, LJ., Chen, JY.[2020]

Volume-targeted ventilation (VTV) significantly reduces the incidence of bronchopulmonary dysplasia (BPD) and the duration of mechanical ventilation in preterm infants, based on a meta-analysis of 18 trials.

VTV also lowers the risk of serious complications such as intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), and pneumothorax, but does not significantly reduce mortality compared to pressure-limited ventilation (PLV).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volume-targeted ventilation is more suitable than pressure-limited ventilation for preterm infants: a systematic review and meta-analysis. Peng, W., Zhu, H., Shi, H., et al.[2022]

Conventional mechanical ventilation has been the standard treatment for neonatal respiratory failure for over 40 years, primarily using time-cycled pressure-limited ventilation methods.

Recent advancements in microprocessor-based devices now allow clinicians to effectively use volume-targeted ventilation, overcoming previous technological limitations and providing more options for treating neonatal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical ventilation of the neonate: should we target volume or pressure? Donn, SM., Boon, W.[2009]

Volume-targeted ventilation (VTV) significantly reduces the rates of death or bronchopulmonary dysplasia (BPD) in newborn infants compared to pressure-limited ventilation (PLV), with a typical risk ratio of 0.73 based on moderate quality evidence from 20 trials involving 1065 infants.

VTV also leads to fewer pneumothoraces, shorter duration of mechanical ventilation, and lower rates of severe cranial ultrasound pathologies without increasing adverse outcomes, indicating it may be a safer and more effective ventilation strategy for vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volume-targeted versus pressure-limited ventilation in neonates. Klingenberg, C., Wheeler, KI., McCallion, N., et al.[2023]

In a study of 52 neonates with neonatal respiratory distress syndrome (NRDS), volume-targeted ventilation (VTV) was found to significantly reduce the time of invasive ventilation compared to pressure-controlled ventilation (PCV).

The VTV method also resulted in lower rates of complications such as hypocapnia, ventilator-associated pneumonia (VAP), and periventricular leukomalacia (PVL), suggesting it may be a safer and more effective option for treating NRDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of volume-targeted ventilation for the treatment of neonatal respiratory distress syndrome]. Liu, CZ., Huang, BY., Tan, BY., et al.[2023]

Volume-targeted ventilation is more physiologically appropriate than pressure-limited ventilation for preterm neonates, leading to better outcomes.

This method is associated with a lower risk of complications such as pneumothorax, hypocarbia, and severe intraventricular hemorrhage, suggesting it should be the preferred approach for mechanical ventilation in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volume-limited and volume-targeted ventilation. Morley, CJ.[2013]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Volume-targeted versus pressure-limited ventilation for preterm infants. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Volume-targeted ventilation is more suitable than pressure-limited ventilation for preterm infants: a systematic review and meta-analysis. [2022]

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

Mechanical ventilation of the neonate: should we target volume or pressure? [2009]

4. England pubmed.ncbi.nlm.nih.gov

Volume-targeted versus pressure-limited ventilation in neonates. [2023]

5. China pubmed.ncbi.nlm.nih.gov

[Efficacy of volume-targeted ventilation for the treatment of neonatal respiratory distress syndrome]. [2023]

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

Volume-limited and volume-targeted ventilation. [2013]