Mask Ventilation Techniques for Neonatal Respiratory Distress Syndrome

(VOLT Trial)

Overseen By Georg Schmölzer, MD, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Congenital abnormalities, Congenital heart disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate (during delivery room stay)

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to assist newborns who struggle to breathe immediately after birth. It tests two methods of providing breathing support to premature infants: one using a set volume of air (volume-targeted ventilation) and another using a set pressure (pressure-targeted ventilation). The goal is to determine which method is more effective in the delivery room. Babies born very early, between 23 and 28 weeks, who receive full resuscitation (complete medical assistance to breathe) may qualify for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance care for premature infants.

Will I have to stop taking my current medications?

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

What prior data suggests that these ventilation techniques are safe for neonatal respiratory distress syndrome?

Research has shown that volume-targeted ventilation (VTV) might be easier for newborns to handle than pressure-targeted ventilation. Studies have found that babies using VTV experienced fewer serious lung issues and spent less time on ventilators. This suggests that VTV could be safer for newborns, reducing the risk of problems like lung damage.

Pressure-targeted ventilation is often the first choice for treating newborns with breathing difficulties. It is generally safe and effective, but some studies suggest that VTV might lead to better outcomes in certain situations.

Both methods are used in newborn care, and doctors are familiar with each. While VTV may offer some benefits, both treatments are usually well-tolerated by newborns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two innovative ventilation techniques for treating Neonatal Respiratory Distress Syndrome. Unlike traditional methods that often rely on varied approaches to set pressure, this trial investigates volume-targeted ventilation, which uses a set tidal volume, providing more consistent lung inflation. Additionally, pressure-guided ventilation aims to optimize oxygen delivery by using a set peak inflation pressure, potentially reducing lung injury. These techniques could offer more precise and effective respiratory support for newborns, leading to better outcomes.

What evidence suggests that this trial's ventilation techniques could be effective for neonatal respiratory distress syndrome?

Research has shown that volume-targeted ventilation (VTV), one of the techniques under study in this trial, might help treat breathing problems in newborns. Studies have found that babies using VTV are more likely to survive without lung damage and often need less assistance from breathing machines. One review suggested that VTV can reduce the risk of death or chronic lung disease in newborns. Overall, VTV appears promising for helping newborns with breathing issues. Another technique being studied in this trial is pressure-guided ventilation, which provides positive pressure ventilation using a set peak inflation pressure. ^{1 4 6 7 8}

Who Is on the Research Team?

Georg Schmölzer, MD, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Pressure targeted ventilation
• Volume targeted 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.

How Is the Trial Designed?

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 European Union, United States, Canada for the following indications:

Approved in European Union as Pressure-Limited Ventilation for:

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

Approved in United States as Pressure-Limited Ventilation for:

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

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6485452/

Volume‐targeted versus pressure‐limited ventilation in ... Key results: Babies ventilated using volume‐targeted modes of ventilation were more likely to survive free of lung damage. They needed ventilator assistance for ...

2. publications.aap.org publications.aap.org/neoreviews/article/7/5/e250/87105/Volume-targeted-Ventilation

Volume-targeted Ventilation | NeoReviews Significant fall in lung compliance, decreased spontaneous respiratory effort, impending accidental extubation, and forced exhalation episodes ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07564-x

Volume-targeted ventilation vs pressure-controlled ventilation ... Systemic review suggested that VTV decreases the incidence of death or BPD in neonates compared to PLV; however, this study did not specifically ...

4. zgddek.com zgddek.com/EN/abstract/abstract13832.shtml

Efficacy of volume-targeted ventilation for the treatment ... Objective To investigate the efficacy of volume-targeted ventilation (VTV) for the treatment of neonatal respiratory distress syndrome (NRDS).

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03938532

Feasibility and Impact of Volume Targeted Ventilation in ... The investigators will also aim to understand the pulmonary mechanics and physiology during VTV. A successful Phase II will demonstrate VTV is feasible, is ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK560779/

Neonatal Respiratory Distress Syndrome - StatPearls - NCBI Time-cycled pressure limited ventilation is the preferred initial mode of ventilation in preterm infants with RDS. High-frequency oscillatory ventilation ...

7. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-015-0843-7

Mechanical ventilation modes for respiratory distress ... Compared with the SIMV + PSV ventilation mode, the TCPL, HFOV, SIMV + VG, and V-C ventilation modes are associated with lower mortality.

8. researchgate.net researchgate.net/profile/Colin-Morley-2/publication/320458654_Volume-targeted_versus_pressure-limited_ventilation_in_neonates/links/5a27e6d1aca2727dd883df62/Volume-targeted-versus-pressure-limited-ventilation-in-neonates.pdf

Volume-targeted versus pressure-limited ventilation in the ... Volume-targeted versus pressure-limited ventilation in the neonate. Cochrane Database of Systematic Reviews 2017, Issue 4. Art. No.: CD003666. DOI: 10.1002/ ...