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

Not Applicable

Completed

• Conditions: High Frequency Oscillation Ventilation; Acute Respiratory Distress Syndrome; Conventional Mechanical Ventilation

• 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
• Status Verified: 2022-10
• Study Start: 2024-12-31
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 386

Inclusion Criteria

• Gestational age (GA) between 25+0 and 34+0 weeks;
• Assisted with CMV within 12 h after birth;
• Diagnosis with ARDS;
• Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH > 7.20, PaCO2 60 mmHg and > 35% of hematocrit

Exclusion Criteria

• parents' decision not to participate;
• Major congenital anomalies or chromosomal abnormalities;
• Upper respiratory tract abnormalities;
• need for surgery before randomization;
• Grade Ⅲ-IV-intraventricular hemorrhage (IVH).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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