VTV for Bronchopulmonary Dysplasia

N/A

Recruiting

Led By Ruben Vaidya, MD

Research Sponsored by Baystate Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Requiring intubation and positive pressure ventilation in the delivery room

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 5 mins of life

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study whether volume targeted ventilation is safer and more effective than pressure limited ventilation for intubated infants, with the goal of reducing bronchopulmonary dysplasia.

Who is the study for?

This trial is for premature infants born at less than 32 weeks of gestation, who need breathing support right after birth and are delivered at Baystate Medical Center. Parents must consent to participate. Infants with long-term membrane rupture or immediate congenital or cardiac issues can't join.

What is being tested?

The study tests Volume Targeted Ventilation (VTV) against the usual pressure-limited method in newborns needing ventilation. It aims to show VTV's feasibility, its effect on lung inflation stability, and whether it reduces oxygen needs without increasing risks compared to standard care.

What are the potential side effects?

Since this trial involves vulnerable preterm infants and a new ventilation technique, potential side effects may include variations in blood gases levels or impacts on delicate lung tissues; however, specific side effects will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I needed a breathing tube and mechanical ventilation at birth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first 5 mins of life

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first 5 mins of life

This trial's timeline: 3 weeks for screening, Varies for treatment, and first 5 mins of life for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Timing of initiation of mechanical ventilation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

Infants in the intervention arm will receive VTV following intubation. Peak inspiratory pressure (PiP) provided via T-piece resuscitator will be visible to the providers, and the provider can regulate the PiP to achieve the desired TV goal (4-6 ml/kg), at a rate of 40-60 breaths/min

Group II: Control ArmActive Control1 Intervention

Infant will receive pressure regulated breaths, 40-60 breaths/min, PiP of 20-24cm of water as recommended by 2017 Neonatal Resuscitation Program (NRP) guidelines. Reading of the TV will be blinded from the providers as in routine clinical situations

0 / 1Eligibility criteria met