Ventilator Pressure for Premature Birth

(VPOCH Trial)

Overseen By Kulsajan S Bhatia, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Pressors, Steroids

Disqualifiers: Sepsis, Congenital anomalies, Heart disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 hours

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how changing ventilator pressure affects very premature babies with breathing problems. Researchers aim to determine if adjusting the pressure can enhance heart function and oxygen levels. Babies will experience different pressure settings: a decrease in positive end-expiratory pressure (PEEP) followed by an increase, or vice versa, to identify the optimal setting for their heart and lungs using special imaging tools. This trial targets preterm infants over a week old, born before 34 weeks, who still require ventilator support. As an unphased trial, it seeks to explore innovative methods to improve breathing support for premature infants, offering a chance to contribute to vital research.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for preterm infants?

Research has shown that adjusting positive end-expiratory pressure (PEEP) levels in ventilated preterm infants is generally safe. Studies have found that a short-term increase in PEEP does not significantly alter blood flow in the body. However, about 36% of infants experienced some important clinical changes.

One study discovered that increasing PEEP at birth and then lowering it later effectively opens the baby's lungs. This method is commonly used to assist breathing in preterm infants. Experts recommend a PEEP level of at least 5-6 cm H2O to support these infants' breathing, as their lungs require extra help.

Overall, using PEEP is a standard part of care for preterm infants, indicating it is well-tolerated. While some infants may experience important changes, this approach is widely used and considered safe for helping preterm babies breathe early on. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different sequences of adjusting PEEP (positive end-expiratory pressure) levels might improve outcomes for premature infants on ventilators. Unlike standard ventilator settings that typically maintain a stable PEEP, this trial investigates the effects of changing PEEP settings either by decreasing first and then increasing, or vice versa. The unique approach could reveal insights into optimizing respiratory support and cardiac function in these vulnerable infants, potentially leading to more personalized and effective care strategies.

What evidence suggests that this trial's treatments could be effective for improving cardiac output and oxygenation in preterm infants?

This trial will compare two methods of adjusting positive end-expiratory pressure (PEEP) to help premature babies breathe better. In one treatment arm, infants will have their PEEP decreased and then increased, potentially improving oxygen levels by keeping their lungs open and easing breathing. In the other treatment arm, infants will start with a high PEEP that is then lowered, which can increase lung size and improve lung function, allowing more air to enter when the lungs are hard to open. Both methods aim to provide optimal breathing support for these tiny newborns. ^{2 6 7 8 9}

Who Is on the Research Team?

Kulsajan S Bhatia, MD

Principal Investigator

University of Alabama at Birmingham

Colm P Travers, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for preterm infants born before 34 weeks' gestation, currently on mechanical ventilation or high-frequency jet ventilation (HFJV), over 7 days old but less than a month, and with consent from their legal guardian. Infants must be recovering from respiratory distress syndrome (RDS).

Inclusion Criteria

I am between 21 and 34 weeks pregnant.

My baby was born before 34 weeks, has RDS, and is on a ventilator.

My baby is older than 7 days but younger than 1 month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Baseline assessment of cardiac hemodynamics and respiratory status at the current set PEEP level

1 day

1 visit (in-person)

Treatment

Infants undergo a 4-hour crossover period of increasing and decreasing PEEP with echocardiography and EIT measurements

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Decrease in the PEEP followed by increase in the PEEP
• Increase in the PEEP followed by decrease in the PEEP

Trial Overview The study tests how changing the positive end-expiratory pressure (PEEP) affects lung compliance, oxygen levels, and heart function in these infants. It uses echocardiography and electrical impedance tomography to measure outcomes after alternating PEEP levels during a crossover period.

How Is the Trial Designed?

Group I: cardiac hemodynamics and respiratory status assessment with increasing PEEP Experimental Treatment 1 Intervention

Infants will be randomized to the order of changes in PEEP levels during mechanical ventilation - increase followed by decrease in PEEP. Baseline parameters looking into cardiac hemodynamics as well as compliance and respiratory mechanics will be assessed using EIT

Group II: cardiac hemodynamics and respiratory status assessment with decreasing PEEP Active Control 1 Intervention

Infants will be randomized to the order of changes in PEEP levels during mechanical ventilation - decrease followed by increase in PEEP. Baseline parameters looking into cardiac hemodynamics as well as compliance and respiratory mechanics will be assessed using EIT

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6395956/

Positive end‐expiratory pressure for preterm infants requiring ... Low‐quality data suggests that selecting PEEP levels through the application of an oxygenation‐guided LRM may result in clinical benefit.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04372953

NCT04372953 | Positive End-Expiratory Pressure (PEEP) ... The others is to give a high PEEP level at birth when the lungs are hardest to open and then decrease the PEEP later once the lungs are opened and the baby is ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12466999/

High PEEP Increases Airway Dead Space and Decreases ... The PEEP level was increased from mild to high (the incremental phase) and then decreased from high to mild (the decremental phase) while performing the Vcap,PM ...

4. publications.aap.org publications.aap.org/pediatrics/article/146/4/e20200494/79652/Positive-End-Expiratory-Pressure-in-Newborn

Positive End-Expiratory Pressure in Newborn ... The objective was to determine if adding a new PEEP valve to the bag-mask during resuscitation of term and near-term newborns could improve heart rate response.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1744165X22000063

Respiratory support of infants born at 22–24 weeks ... A meta-analysis comparing extubation with nCPAP or NIPPV in preterm infants found no differences in rates of BPD or mortality between the groups, but no ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2675387/

Cardiorespiratory effects of changes in end expiratory ... A short‐term increase in PEEP does not lead to significant changes in systemic blood flow, although 36% of infants in the present study had clinically important ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04372953/positive-end-expiratory-pressure-peep-levels-during-resuscitation-of-preterm-infants-at-birth-the-polar-trial

Positive End-Expiratory Pressure (PEEP) Levels During ... In this study, the Investigators will look at 2 different approaches to PEEP to help premature babies during their first breaths at birth. At ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0146000521001543

Respiratory management for extremely premature infants ... Survival of preterm newborn infants have increased steadily since the introduction of surfactant treatment and antenatal steroids.

9. withpower.com withpower.com/trial/phase-hypoxia-9-2024-f163a

Ventilator Pressure for Premature Birth (VPOCH Trial) Infants will be randomized to the order of changes in PEEP levels during mechanical ventilation - increase followed by decrease in PEEP. Baseline parameters ...