RecruitingOBSERVATIONAL

ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)

The ASCEND study is working with families whose children needed a treatment called ECMO because of serious breathing difficulties, known as ARDS. ECMO is like an artificial lung that works outside the body. This study wants to understand how children who had ECMO are doing in the year after leaving hospital, looking at their abilities and quality of life. They are also comparing two groups of children: those whose ECMO was used when other treatments weren't enough, and those who received ECMO as standard care. The aim is to find the best way to use ECMO to help children survive and have the best possible long-term health and quality of life.

At a glance

Status

Recruiting

Sponsor

University of Michigan

Enrolment target

550

Start

04 Feb 2021

Estimated completion

30 Sep 2027

Acute Respiratory Distress Syndrome Extracorporeal Membrane Oxygenation

What is this study about?

The ASCEND study is all about helping children who suffer from a very serious breathing problem called Acute Respiratory Distress Syndrome (ARDS). When a child has ARDS, their lungs aren't working properly, and they can become very ill. Sometimes, a special life support machine called ECMO (Extracorporeal Membrane Oxygenation) is needed to help them breathe. ECMO acts like an artificial lung, taking over the job of adding oxygen to the blood and removing carbon dioxide.

For a long time, doctors have used ECMO, but we still don't fully understand the best time to start this treatment or how children completely recover afterwards. This study wants to learn more about children's health and how well they do in the year after having ECMO, focusing on their abilities and how good their quality of life is. They are also comparing two different approaches to using ECMO: one where ECMO is held back until other treatments have not worked, and another where ECMO is used based on the doctors' usual approach.

By comparing these groups, researchers hope to figure out if there's a particular way or time to introduce ECMO that leads to better long-term outcomes for children, including better survival and a better quality of life. This knowledge will help doctors make the best decisions for children with ARDS in the future.

Key takeaways

The study helps us understand how children recover after serious breathing problems requiring life support.
It compares different ways of using ECMO (a type of artificial lung) to see what works best.
Information will be collected about children's abilities and quality of life for a year after leaving hospital.
Participation involves sharing existing medical information and completing surveys, with no changes to medical care.
The aim is to improve care and long-term outcomes for children with severe lung conditions in the future.

Who may be eligible?

This study is looking for children aged between 14 days and 20 years old. To be included, they must have needed ECMO support for breathing difficulties, specifically due to ARDS. There are also specific medical details about their lung condition and how long they had been unwell before starting ECMO that researchers will check.

There are several reasons why a child might not be able to join the study. For example, if their breathing problem was due to a heart condition, or if they had significant existing medical issues like certain lung diseases or brain injuries. Children who have previously taken part in a similar study called PROSpect, or whose families have decided not to pursue full medical support, also wouldn't be eligible. The hospital team will carefully check all these details to see if a child can take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child between 14 days and 20 years old?
Did your child receive ECMO for severe breathing problems?
Was your child's breathing problem not primarily caused by a heart issue or existing lung disease?
Has your family agreed to your child receiving full medical support?
Has your child not been part of the PROSpect study before?

Answer every question to see your result.

What does participation involve?

If a child takes part in the ASCEND study, it mainly involves collecting information about their health and development. This information will come from existing medical records and from surveys completed by their families. You and your child would not undergo any new medical procedures specifically for this study.

The research team will gather details about your child's health before they became unwell, when they leave the intensive care unit, and then at 1, 3, 6, and 12 months after leaving hospital. This information will be collected through questionnaires about their general abilities and quality of life. There are no study medications, extra appointments, or specific treatments. The study aims to follow how children are doing over a year after their hospital discharge.

Potential risks and benefits

Taking part in this study does not involve any additional medical treatments or interventions, so there are no new medical risks associated with participation. The main benefit is that the information gathered will help doctors better understand the long-term effects of ECMO and identify the best ways to use it for children with severe breathing problems, potentially improving care for future patients. Families can also be reassured that they have the right to withdraw their child from the study at any time without affecting their child's medical care.

Locations (99)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Children's of Alabama
Verified postcode
Birmingham, United States· Recruiting
Phoenix Children's Hospital
Verified postcode
Phoenix, United States· Recruiting
Arkansas Children's Hospital
Verified postcode
Little Rock, United States· Recruiting
Loma Linda University Children's Hospital
Verified postcode
Loma Linda, United States· Recruiting
UCLA Mattel Children's Hospital
Verified postcode
Los Angeles, United States· Recruiting
Valley Children's Hospital
Verified postcode
Madera, United States· Recruiting
UCSF Benioff Children's Hospital Oakland
Verified postcode
Oakland, United States· Recruiting
Children's Hospital of Orange County
Verified postcode
Orange, United States· Recruiting
Lucile Packard Children's Hospital Stanford
Verified postcode
Palo Alto, United States· Recruiting
UCSF Benioff Children's Hospital - San Francisco
Verified postcode
San Francisco, United States· Recruiting
Children's Hospital Colorado
Verified postcode
Aurora, United States· Recruiting
Connecticut Children's Medical Center
Verified postcode
Hartford, United States· Recruiting

Common questions

What is ARDS in children?

ARDS in children is a severe lung condition where the lungs become very inflamed and struggle to get enough oxygen into the blood.

What is ECMO?

ECMO is a life support machine that works like an artificial lung outside the body, helping to oxygenate the blood when a child's own lungs are too sick to do the job.

Will my child receive different medical care if they join this study?

No, your child will receive the usual medical care their doctors determine is best. This study only collects information, it doesn't change treatment.

How long will my child be followed for this study?

The study will gather information about your child's health and development for up to one year after they leave the hospital.

What is the main goal of the ASCEND study?

The main goal is to understand how children recover after ECMO for ARDS, and to find the best strategies for using ECMO to help children have good long-term health and quality of life.

How to find out more

Kelli McDonough, MS

kellimcd@umich.edu 734-232-1998 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.