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Device

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Timing of initiation of mechanical ventilation

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

Find a Location

Who is running the clinical trial?

Baystate Medical CenterLead Sponsor

63 Previous Clinical Trials

44,233 Total Patients Enrolled

Ruben Vaidya, MDPrincipal InvestigatorBaystate Medical Center

Media Library

Philips Respironics NM3 monitor (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03938532 — N/A

Neonatal Respiratory Distress Syndrome Research Study Groups: Control Arm, Intervention Arm

Neonatal Respiratory Distress Syndrome Clinical Trial 2023: Philips Respironics NM3 monitor Highlights & Side Effects. Trial Name: NCT03938532 — N/A

Philips Respironics NM3 monitor (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03938532 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this research project still open?

"As per the records posted on clinicaltrials.gov, this trial is actively seeking participants with a start date of July 11th 2019 and an update made to it on July 18th 2022."

Answered by AI

What qualifications must be met to participate in this medical experiment?

"To qualify for this clinical trial, newborns suffering from respiratory distress syndrome must be between 5 minutes and an hour old. The recruitment process seeks 40 participants in total."

Answered by AI

How many participants has this clinical trial been limited to?

"Affirmative. Documentation archived on clinicaltrials.gov reveals that this experiment is actively seeking participants, having been posted since July 11th 2019 and recently updated on the 18th of July 2022. The research seeks to enrol 40 patients from a single clinic."

Answered by AI

Does the trial encompass adults of all ages or is it restricted to those over 18?

"The requirements for this experiment necessitate that potential participants are between 5 Minutes and 60 Minutes old. There are currently 121 studies available for people under 18 years of age, with 146 additional studies accessible to patients 65 or older."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility and Impact of Volume Targeted Ventilation in the Delivery Room

Ruben 2019. "Feasibility and Impact of Volume Targeted Ventilation in the Delivery Room". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03938532.