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

Launched by UNIVERSITY OF MICHIGAN · May 18, 2022

Keywords

ClinConnect Summary

The ASCEND trial is studying how children who need a special life support treatment called extracorporeal membrane oxygenation (ECMO) after a serious breathing problem called pediatric acute respiratory distress syndrome (PARDS) do over time. ECMO acts like an artificial lung, helping children breathe when their own lungs can't work properly. The researchers want to understand how these children are doing one year after leaving the hospital and to compare two different ways of managing their care: one that uses ECMO only if a certain type of breathing support doesn't work, and another that uses ECMO as part of the standard care right from the start.

To participate in the trial, children need to be between 14 days to 21 years old and must have needed ECMO support within 10 days of being intubated (having a tube placed to help them breathe). They should have certain lung problems visible on an X-ray and meet specific medical criteria related to their breathing conditions. Families participating in the study can expect regular follow-ups to assess their child's development and quality of life after leaving the intensive care unit. This research is important because it aims to improve the care and outcomes for children facing these serious health challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Time between intubation and ECMO cannulation is less than 240 hours (10 days)
• • ECMO support type is respiratory (VV or VA cannulation)
• • Chest radiograph with bilateral lung disease
• * Moderate or severe pediatric ARDS as measured by oxygenation index or oxygen saturation index after intubation and prior to ECMO cannulation:
• • One OI ≥ 16 or Two OIs ≥ 12 and ≤ 16 at least four hours apart or Two OSIs ≥ 10 at least four hours apart or One OI ≥ 12 and ≤ 16 and One OSI ≥ 10 at least four hours apart
• Exclusion Criteria:
• • Previously enrolled in PROSpect
• • Perinatal related lung disease
• • Congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis
• • Respiratory failure caused by cardiac failure or fluid overload
• • Cyanotic congenital heart disease
• • Cardiomyopathy
• • Primary pulmonary hypertension (PAH)
• • Unilateral lung disease
• • Intubated for status asthmaticus
• • Obstructive airway disease
• • Bronchiolitis obliterans
• • Post hematopoietic stem cell transplant
• • Post lung transplant
• • Home ventilator dependent
• • Neuromuscular respiratory failure
• • Head trauma: (managed with hyperventilation)
• • Intracranial bleeding
• • Unstable spine, femur or pelvic fractures
• • Acute abdominal process/open abdomen
• • Family/medical team have decided to not provide full support
• • Enrolled in interventional clinical trial: not approved for co-enrollment; does not include cancer protocols.
• • Known pregnancy