Active not recruitingNAINTERVENTIONAL

PROSpect: Prone and Oscillation Pediatric Clinical Trial

This important study, called PROSpect, is looking for the best ways to treat children with a serious lung condition called Severe Pediatric Acute Respiratory Distress Syndrome (PARDS). This condition makes it very hard for children to breathe and is often life-threatening. The study will compare two main approaches: how children are positioned (lying on their back or on their front) and the type of breathing support they receive (two different ventilator settings). Researchers want to find out which combination helps children recover more quickly and spend fewer days needing a breathing machine. They hope this will lead to better care for thousands of children who experience this critical illness each year.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Pennsylvania

Enrolment target

600

Start

01 May 2019

Estimated completion

31 Jan 2027

Acute Respiratory Distress Syndrome in Children

What is this study about?

Severe Pediatric Acute Respiratory Distress Syndrome, or PARDS, is a very serious lung condition that affects many children each year, making it really hard for them to breathe. When a child has PARDS, their lungs are too sick to work properly, and they often need help from a special breathing machine called a ventilator. This can be a very worrying time for families, and doctors are always looking for better ways to support these children.

This study, called PROSpect, is trying to find the very best ways to care for children with severe PARDS. It focuses on two main things: the child's body position and the type of breathing machine support they receive. Doctors want to see if lying a child on their front (called prone positioning) helps more than lying them on their back. They also want to compare two different settings on breathing machines to see if one is more effective. By looking at these four combinations, the researchers hope to discover which treatments lead to the best recovery and help children get off the breathing machine sooner.

The main goal is to help children with PARDS spend less time on a ventilator, as this often means they are recovering better. The study also looks at other important things, like how it affects other organs, how long children stay in the hospital, and how well they are doing after they leave. The information from this study will help doctors around the world provide the best possible care for children with this serious breathing problem.

Key takeaways

Looks at best ways to treat severe breathing problems (PARDS) in children.
Compares lying on front vs. back, and two types of breathing machine settings.
Aims to help children recover faster and spend less time on a ventilator.
Involves children aged 2 weeks to 20 years with new-onset severe PARDS.
Comparing standard, commonly used hospital treatments.
Participation will not affect standard medical care.

Who may be eligible?

This study is looking for children aged between 2 weeks and 20 years who are currently needing help with their breathing using a machine (ventilator) because of severe PARDS. They must have developed this condition within the last two days and meet specific breathing test results showing their lungs are significantly affected.

There are certain reasons why a child would not be able to join the study. This includes if their breathing problems are due to conditions present at birth, certain heart problems, specific types of lung disease like severe asthma flares that don't involve the lung tissue itself, or if they have undergone a lung transplant. Children who already rely on a ventilator at home or have certain serious issues with their airway would also not be able to participate.

Quick self-check

Is your child between 2 weeks and 20 years old?
Is your child currently on a breathing machine for a severe lung problem?
Did this breathing problem start within the last two days?
Does your child *not* have certain pre-existing heart or lung conditions (like severe asthma flares, or some conditions present from birth)?
Is your child *not* already dependent on a home breathing machine?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child is eligible and you agree for them to take part, they would be randomly assigned to one of four treatment groups. This means they would either be placed on their back or their front, and receive one of two common types of breathing machine settings. Doctors will closely monitor your child's breathing and overall health throughout this time. If your child isn't responding well to their assigned treatment, the medical team might switch them to the other position or type of breathing support, and further specialized care might be considered. The main focus of the study is to see how many days your child spends without needing the breathing machine over a 28-day period. Researchers will also check in on your child's health for up to 90 days after leaving the hospital, looking at things like their recovery and quality of life.

Potential risks and benefits

Taking part in this study means your child will receive care for their severe lung condition using methods that are already common in hospitals, but the specific combination of position and breathing machine settings will be chosen randomly. The main potential benefit is that one of these approaches might prove to be more effective than others, leading to better outcomes for your child and future patients. As with any medical care for a critical illness, there are always some risks involved, but the study therapies themselves are standard care. You are absolutely free to withdraw your child from the study at any time, for any reason, without affecting their medical care.

Locations (49)

Children's of Alabama
Birmingham, United States
Banner Health
Phoenix, United States
Arkansas Children's Hospital
Little Rock, United States
Children's Hospital Orange County
Orange, United States
Stanford Children's Health
Palo Alto, United States
Kapiolani Medical Center for Women and Children
Honolulu, United States
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, United States
Riley Hospital for Children at IU Health
Indianapolis, United States
University of Iowa Stead Family Chlldren's Hospital
Iowa City, United States
Norton Children's Hospital
Louisville, United States
Bloomberg Children's Center, Johns Hopkins University
Baltimore, United States
CS Mott Children's Hospital
Ann Arbor, United States

+37 more sites — see the official record for the full list.

Common questions

What is PARDS?

PARDS stands for Pediatric Acute Respiratory Distress Syndrome. It's a very serious lung condition in children that makes it hard for them to breathe and often requires help from a breathing machine.

What does 'prone positioning' mean?

Prone positioning simply means carefully placing your child to lie on their front, rather than on their back.

Will my child get special care if they join?

Your child will receive exactly the same high-standard care they would normally get for their condition, but their specific position and breathing machine settings will be part of the study.

Why are these specific treatments being tested?

Doctors want to find out which combinations of body position and breathing machine settings work best to help children with severe PARDS recover faster and spend less time on a ventilator.

How long will my child be in the study?

The main part of the study looks at the first 28 days, focusing on how long your child needs the breathing machine. Their health will also be followed up for up to 90 days after going home.