Extracorporeal Membrane Oxygenation (ECMO)

NCT03607760 | Completed DMC

• 1 other identifier: ECMO
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Extracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (2)

• in-hospital mortality

  the patients died

  36 weeks' gestational age or before discharge from hospital

• 28 days' mortality

  the patients died

  28 days

Secondary Outcomes (3)

• Neonatal necrotizing enterocolitis

  36 weeks' gestational age or before discharge from hospital

• Intraventricular hemorrhage

  36 weeks' gestational age or before discharge from hospital

• bronchopulmonary dysplasia

  36 weeks' gestational age or before discharge from hospital

Study Arms (2)

ECMO

severe respiratory failure with ECMO

Device: ECMO

conventional mechanical ventilation

severe respiratory failure with conventional mechanical ventilation

Device: conventional mechanical ventilation

Interventions

ECMO DEVICE

the patients with severe respiratory failure were supported by ECMO

ECMO

conventional mechanical ventilation DEVICE

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

conventional mechanical ventilation

Eligibility Criteria

• Age: 1 Hour - 1 Month
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \. 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 \[VIS=dopamine dose (μg/kg/min)×1 + dobutamine dose (μg/kg/min)×1 + milrinone dose (μg/kg/min)×10 + amrinone dose (μg/kg/min)×10 + epinephrine dose (μg/kg/min)×100 + isoprenaline dose (μg/kg/min)×100\]

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• Bayi Children's Hospital Affiliated to PLA Army General Hospital, China: collaborator
• Children's Hospital of Chongqing Medical University: collaborator
• Hunan Provincial People's Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Beijing 302 Hospital: collaborator
• Navy General Hospital, Beijing: collaborator
• Zhengzhou Children's Hospital, China: collaborator
• Guangzhou Women and Children's Medical Center: collaborator

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400042, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: July 31, 2018
• Study Start: November 11, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 4, 2019
• Last Updated: April 10, 2019

Record last verified: 2018-11

Locations

CN (1)