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

NCT05388708 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 550

Last updated 2025-12-24

No results posted yet for this study

Summary

ASCEND researchers are partnering with families of children who receive extracorporeal membrane oxygenation (ECMO) after a sudden failure of breathing named pediatric acute respiratory distress syndrome (PARDS). ECMO is a life support technology that uses an artificial lung outside of the body to do the lung's work. ASCEND has two objectives.

The first objective is to learn more about children's abilities and quality of life among ECMO-supported children in the year after they leave the pediatric intensive care unit. The second objective is to compare short and long-term patient outcomes in two groups of children: one group managed with a mechanical ventilation protocol that reserves the use of extracorporeal membrane oxygenation (ECMO) until protocol failure to another group supported on ECMO per usual care.

Conditions

  • Acute Respiratory Distress Syndrome
  • Extracorporeal Membrane Oxygenation

Interventions

DEVICE

ECMO support

ECMO prescribed by treating physicians for respiratory support in the setting of PARDS.

OTHER

PROSpect protocolized therapies

PROSpect is testing the impact of supine/prone positioning and conventional mechanical ventilation (CMV)/high-frequency oscillatory ventilation (HFOV) on clinical outcomes in 1,000 children with severe PARDS. PROSpect manages severe PARDS subjects using a protocol that reserves ECMO for protocol failure. The CMV group targets an exhaled tidal volume of 5-7mL/kg of ideal body weight and a peak inspiratory pressure \<28 cm of H2O. The positive end expiratory pressure (PEEP) and FiO2 are titrated by a PEEP-FiO2 titration grid. The HFOV group titrates the mean airway pressure to target a FiO2 \< 0.5 and a goal hemoglobin oxygen saturation of 88-92%. The frequency is titrated between 8-12 Hz and amplitude from 60-90 to achieve a goal pH of 7.15-7.30. Ventilation protocols are implemented until 28 days or extubation. Children randomized to the prone positioning will remain prone for at least 16 consecutive hours per day. Children randomized to supine positioning group remain supine.

Sponsors & Collaborators

Principal Investigators

  • Ryan Barbaro, MD · University of Michigan

Eligibility

Min Age
14 Days
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-04
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • United States
  • Australia
  • Canada
  • Chile
  • Colombia
  • Italy
  • New Zealand
  • Portugal
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05388708 on ClinicalTrials.gov