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

NCT03372525 | Unknown DMC

• 1 other identifier: MV for ARDS
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; High Frequency Oscillation Ventilation

Outcome Measures

Primary Outcomes (2)

• bronchopulmonary dysplasia (BPD)

  neonate was diagnosed with BPD

  28 days after birth or 36 weeks'gestational age or before discharge

• death

  the included preterm infants were dead

  28 days after birth or 36 weeks'gestational age or before discharge

Secondary Outcomes (3)

• air leak

  28 days after birth or 36 weeks'gestational age or before discharge

• the incidence of retinopathy of prematurity(ROP)

  28 days after birth or 36 weeks'gestational age or before discharge

• the incidence of neonatal necrotizing enterocolitis(NEC)

  28 days after birth or 36 weeks'gestational age or before discharge

Study Arms (2)

HFOV

EXPERIMENTAL

Ventilated infants were randomized to HFOV.

Device: HFOV

CMV

ACTIVE COMPARATOR

Ventilated infants were randomized to CMV.

Device: CMV

Interventions

HFOV DEVICE

Infants were randomized to HFOV

HFOV

CMV DEVICE

Infants were randomized to CMV

CMV

Eligibility Criteria

• Age: 1 Minute - 12 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• Children's Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: When the neonate had fulfilled the included criteria, selective HFOV or CMV were started immediately on the basis of the group assignment.

Study Record Dates

• First Submitted: December 9, 2017
• First Posted: December 13, 2017
• Study Start: December 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

CN (1)