Invasive Ventilation Strategies for Neonates With Acute Respiratory Distress Syndrome Syndrome (ARDS)

Not Applicable

Recruiting

• Conditions: Acute Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; High Frequency Oscillation Ventilation
• Interventions: Device: CMV; Device: HFOV

• Registration Number: NCT03372525
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death rate is over 50%. HFOV and CMV are two main invasive ventilation strategies. However, which one is better needing to be further elucidated.

Detailed Description

Severe acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. Usually, invasive ventilation with low parameters is enough for neonates with mild and moderate ARDS. And extracorporeal membrane oxygenation is used to neonates with severe ARDS. However, extracorporeal membrane oxygenation can also lead to high death rate and need more technique and conditions. Mechanical ventilation with higher parameters was a substitute for such situations, but the death rate, complications and injuries of higher parameters is unknown. The purpose of the present study was to compare HFOV with CMV as invasive respiratory support strategies on decrease the mortality and morbidities in neonate with ARDS.

Study Timeline

• Study First Submitted: 2017-12-09
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-13
• Study Start: 2018-12-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• For a neonate to be included, the following four criteria must be fulfilled: (1)gestational age (GA) between 26+0 and 32+0 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings); (2)Birth weight less than 2000g; (3) assisted with CMV within 12 h after birth; (4)diagnosis with ARDS and/or RDS. (5)stabilization before randomization within 12 h after birth: FiO2<=0.30, pH>7.20, PaCO2<=60 mmHg, Paw <=7-8 cmH2O;

Exclusion Criteria

• neonates with at least one of the following criteria are not eligible for the study: (1) Neonates who only needed noninvasive ventilation; (2) major congenital anomalies or chromosomal abnormalities; (3) neuromuscular diseases; (4) upper respiratory tract abnormalities; (5) need for surgery known before the first extubation; (6) Grade Ⅲ-IV-intraventricular hemorrhage (IVH); (7) congenital lung diseases or malformations or pulmonary hypoplasia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CMV	CMV	Ventilated infants were randomized to CMV.
HFOV	HFOV	Ventilated infants were randomized to HFOV.

Primary Outcome Measures

Name	Time	Method
bronchopulmonary dysplasia (BPD)	28 days after birth or 36 weeks'gestational age or before discharge	neonate was diagnosed with BPD
death	28 days after birth or 36 weeks'gestational age or before discharge	the included preterm infants were dead

Secondary Outcome Measures

Name	Time	Method
the incidence of retinopathy of prematurity(ROP)	28 days after birth or 36 weeks'gestational age or before discharge	the included preterm infants were diagnosed with ROP
the incidence of neonatal necrotizing enterocolitis(NEC)	28 days after birth or 36 weeks'gestational age or before discharge	the included preterm infants were diagnosed with NEC
air leak	28 days after birth or 36 weeks'gestational age or before discharge	the included preterm infants were diagnosed with air leak

Trial Locations

Locations (1)

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China