Clinical trial NCT03607760: Extracorporeal Membrane Oxygenation (ECMO)
Official title: Extracorporeal Membrane Oxygenation (ECMO) and Neonatal Outcomes:a Retrospective Multicenters Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extracorporeal Membrane Oxygenation
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
name: Children's Hospital of Chongqing Medical University
name: Hunan Provincial People's Hospital
name: The First Hospital of Jilin University
name: Beijing 302 Hospital
name: Navy General Hospital, Beijing
name: Zhengzhou Children's Hospital, China
name: Guangzhou Women and Children's Medical Center
First posted: 2018-07-31
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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

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)

Eligibility criteria: Inclusion Criteria:

1. ECMO group:

1. Oxygenation Index \> 40 for \>4 hours
2. Failure to wean from 100% oxygen despite prolonged (\> 48h) maximal medical therapy or persistent episodes of decompensation
3. Severe hypoxic respiratory failure with acute decompensation (PaO2 \<40) unresponsive to intervention
4. 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:

1. Oxygenation Index \> 16 and reach the Montreux definition of severe respiratory distress syndrome
2. 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:

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

Primary outcomes:
measure: in-hospital mortality
timeFrame: 36 weeks' gestational age or before discharge from hospital
measure: 28 days' mortality
timeFrame: 28 days
Secondary outcomes:
measure: Neonatal necrotizing enterocolitis
timeFrame: 36 weeks' gestational age or before discharge from hospital
measure: Intraventricular hemorrhage
timeFrame: 36 weeks' gestational age or before discharge from hospital
measure: bronchopulmonary dysplasia
timeFrame: 36 weeks' gestational age or before discharge from hospital
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
Study officials:
References: