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Completed

NCT Number: NCT03607760

Extracorporeal Membrane Oxygenation (ECMO)

Since the 1970s, extracorporeal membrane oxygenation (ECMO) support has been used to support gas exchange for children with severe acute respiratory failure who fail mechanical ventilation. ECMO is more expensive than each of these other procedures.But its action is unclear

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Key information

Age range

1 hour–1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

About this study

Since 1974, eight randomized controlled trials have been reported in ECMO for respiratory failure, and none have included non-neonatal pediatric patients. Cochrane systematic reviews of this evidence concluded that ECMO for neonatal respiratory failure had a survival advantage, but there was insufficient evidence to demonstrate a survival advantage for ECMO used to support respiratory failure in adults. Moreover, these trials were performed prior to 2009, and since then advances in ECMO technology have enhanced the delivery of ECMO support, and new research has changed conventional management of severe acute respiratory distress syndrome (ARDS)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ECMO group:
  • Oxygenation Index > 40 for >4 hours
  • Failure to wean from 100% oxygen despite prolonged (> 48h) maximal medical therapy or persistent episodes of decompensation
  • Severe hypoxic respiratory failure with acute decompensation (PaO2 <40) unresponsive to intervention
  • Severe pulmonary hypertension with evidence of right ventricular dysfunction and/or left ventricular dysfunction. The pulmonary artery pressure > 60mmHg evaluated by the Echo, arterial duct keeps open and the blood flow was either by-level shunt or completely shunt from right side to left side.
  • Non-ECMO group:
  • Oxygenation Index > 16 and reach the Montreux definition of severe respiratory distress syndrome
  • Vasoactive-inotropic score (VIS) ≥ 40 [VIS=dopamine dose (μg/kg/min)×1 + dobutamine dose (μg/kg/min)×1 + milrinone dose (μg/kg/min)×10 + amrinone dose (μg/kg/min)×10 + epinephrine dose (μg/kg/min)×100 + isoprenaline dose (μg/kg/min)×100]

Exclusion criteria

  • Gestational age < 36 weeks, birth weight < 2 kg, day post-birth > 28 days.
  • lethal chromosomal disorder (includes trisomy 13, 18 but not 21) or any other lethal anomaly
  • irreversible brain damage
  • uncontrolled bleeding
  • Grade III or greater intraventricular hemorrhage
  • ventilator days ≥ 15 days.

Treatment and study plan

ECMO

Device

the patients with severe respiratory failure were supported by ECMO

Conventional Mechanical Ventilation

Device

the patients with severe respiratory failure were supported by conventional mechanical ventilation

Primary outcomes

  1. in-hospital mortality

    Time frame: 36 weeks' gestational age or before discharge from hospital

    the patients died

  2. 28 days' mortality

    Time frame: 28 days

    the patients died

Secondary outcomes

  1. Neonatal necrotizing enterocolitis

    Time frame: 36 weeks' gestational age or before discharge from hospital

    Neonatal necrotizing enterocolitis was diagnosed after extubation

  2. Intraventricular hemorrhage

    Time frame: 36 weeks' gestational age or before discharge from hospital

    Intraventricular hemorrhage was diagnosed after extubation

  3. bronchopulmonary dysplasia

    Time frame: 36 weeks' gestational age or before discharge from hospital

    bronchopulmonary dysplasia was diagnosed after extubation

Sponsors and collaborators

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Other

Collaborators

  • Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
  • Beijing 302 Hospital
  • Children's Hospital of Chongqing Medical University
  • Guangzhou Women and Children's Medical Center
  • Hunan Provincial People's Hospital
  • Navy General Hospital, Beijing
  • The First Hospital of Jilin University
  • Zhengzhou Children's Hospital, China

Registry information

Official study title

Extracorporeal Membrane Oxygenation (ECMO) and Neonatal Outcomes:a Retrospective Multicenters Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2018
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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