Extracorporeal Membrane OxygenationNCT03607760
Extracorporeal Membrane Oxygenation (ECMO)
An observational study of Extracorporeal Membrane Oxygenation, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 1 hour to 1 month
- Conditions the study is for
- Extracorporeal Membrane Oxygenation
- What is being tested?
- ECMO and conventional mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2018to 4 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 1 month
- All sexes
- Child
Study population: All the patients will be eligible only when they reach the cutting line in the following: Gestational age > 36 weeks, birth weight > 2 kg, day post-birth < 28 days.
Who may be able to join
- 1. 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.
- 2. 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]
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Extracorporeal Membrane Oxygenation (ECMO) and Neonatal Outcomes:a Retrospective Multicenters Study
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
Read the detailed description
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)
- Conditions
- Extracorporeal Membrane Oxygenation
- Being tested
- ECMO, conventional mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMODevice
the patients with severe respiratory failure were supported by ECMO
conventional mechanical ventilationDevice
the patients with severe respiratory failure were supported by conventional mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| ECMO | severe respiratory failure with ECMO Receives: Device: ECMO | |
| conventional mechanical ventilation | severe respiratory failure with conventional mechanical ventilation Receives: Device: conventional mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
the patients died
Measured: 36 weeks' gestational age or before discharge from hospital
28 days' mortality
the patients died
Measured: 28 days
Secondary outcomes (3)
Neonatal necrotizing enterocolitis
Neonatal necrotizing enterocolitis was diagnosed after extubation
Measured: 36 weeks' gestational age or before discharge from hospital
Intraventricular hemorrhage
Intraventricular hemorrhage was diagnosed after extubation
Measured: 36 weeks' gestational age or before discharge from hospital
bronchopulmonary dysplasia
bronchopulmonary dysplasia was diagnosed after extubation
Measured: 36 weeks' gestational age or before discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start11 Nov 2018
- Primary completion1 Mar 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayi Children's Hospital Affiliated to PLA Army General Hospital, China, Children's Hospital of Chongqing Medical University, Hunan Provincial People's Hospital, The First Hospital of Jilin University, Beijing 302 Hospital, Navy General Hospital, Beijing, Zhengzhou Children's Hospital, China, Guangzhou Women and Children's Medical Center
- Responsible party
- Principal investigator, Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607760
- Sponsor's protocol ID
- ECMO
- Status last verified
- Nov 2018
- First submitted
- 24 Jul 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Membrane Oxygenation (ECMO) and Neonatal Outcomes:a Retrospective Multicenters Study
- ClinicalTrials.gov ID
- NCT03607760
- Acronym / sponsor ID
- ECMO
- Conditions
- Extracorporeal Membrane Oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Bayi Children's Hospital Affiliated to PLA Army General Hospital, China, Children's Hospital of Chongqing Medical University, Hunan Provincial People's Hospital, The First Hospital of Jilin University, Beijing 302 Hospital, Navy General Hospital, Beijing, Zhengzhou Children's Hospital, China, Guangzhou Women and Children's Medical Center
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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)
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMO | – | Device: ECMOsevere respiratory failure with ECMO |
| conventional mechanical ventilation | – | Device: conventional mechanical ventilationsevere respiratory failure with conventional mechanical ventilation |
Who may qualify
- Ages
- 1 hour to 1 month
- Sex
- All
- Age groups
- Child
- Study population
- All the patients will be eligible only when they reach the cutting line in the following: Gestational age > 36 weeks, birth weight > 2 kg, day post-birth < 28 days.
Key inclusion criteria (8 listed)
- 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.
- Oxygenation Index > 16 and reach the Montreux definition of severe respiratory distress syndrome
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECMOthe patients with severe respiratory failure were supported by ECMO | Device | ECMO |
| conventional mechanical ventilationthe patients with severe respiratory failure were supported by conventional mechanical ventilation | Device | conventional mechanical ventilation |
Primary outcome
in-hospital mortality
Time frame: 36 weeks' gestational age or before discharge from hospital
the patients died
28 days' mortality
Time frame: 28 days
the patients died
3 secondary outcomes
Neonatal necrotizing enterocolitis
Time frame: 36 weeks' gestational age or before discharge from hospital
Intraventricular hemorrhage
Time frame: 36 weeks' gestational age or before discharge from hospital
bronchopulmonary dysplasia
Time frame: 36 weeks' gestational age or before discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: 36 weeks' gestational age or before discharge from hospital). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019; AzTrials last refreshed its copy on 28 Oct 2026.