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

Not Applicable

Withdrawn

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

• Registration Number: NCT03591796
• 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: 2018-07-09
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-19
• Study Start: 2018-11-20
• Status Verified: 2022-10
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Gestational age (GA) between 26+0 and 32+0 weeks;
• Birth weight less than 2000g;
• Assisted with CMV within 12 h after birth;
• Diagnosis with ARDS and/or RDS;
• Stabilization before randomization within 12 h after birth: FiO2<=0.30, pH>7.20, PaCO2<=60 mmHg, Paw <=7-8 cmH2O; 90%-95% of SpO2

Exclusion Criteria

• Neonates who only needed noninvasive ventilation;
• Major congenital anomalies or chromosomal abnormalities;
• Neuromuscular diseases;
• Upper respiratory tract abnormalities;
• Need for surgery known before the first extubation;
• Grade Ⅲ-IV-intraventricular hemorrhage (IVH);
• 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
Death	28 days after birth or 36 weeks'gestational age or before discharge	the included preterm infants were dead
the incidence of bronchopulmonary dysplasia (BPD)	28 days after birth or 36 weeks'gestational age	the included neonate was diagnosed with BPD

Secondary Outcome Measures

Name	Time	Method
the incidence of neonatal necrotizing enterocolitis(NEC)	28 days after birth or 36 weeks'gestational age or before discharge	the included neonate was diagnosed with NEC
the incidence of retinopathy of prematurity(ROP)	28 days after birth or 36 weeks'gestational age or before discharge	the included neonate was diagnosed with ROP
Intraventricular hemorrhage	28 days after birth or 36 weeks'gestational age or before discharge	Intraventricular hemorrhage was diagnosed
composite mortality/BPD	28 days after birth or 36 weeks'gestational age or before discharge	composite mortality/BPD was diagnosed
the incidence of airleak	28 days after birth or 36 weeks'gestational age or before discharge	the included neonate was diagnosed with airleak

Trial Locations

Locations (1)

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