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

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

HFOV

CMV

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

1 Minute - 12 Hours (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Children's Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HFOV

CMV

Arm Description

Ventilated infants were randomized to HFOV.

Ventilated infants were randomized to CMV.

Outcomes

Primary Outcome Measures

bronchopulmonary dysplasia (BPD)

neonate was diagnosed with BPD

death

the included preterm infants were dead

Secondary Outcome Measures

air leak

the included preterm infants were diagnosed with air leak

the incidence of retinopathy of prematurity(ROP)

the included preterm infants were diagnosed with ROP

the incidence of neonatal necrotizing enterocolitis(NEC)

the included preterm infants were diagnosed with NEC

Full Information

NCT ID

NCT03372525

First Posted

December 9, 2017

Last Updated

October 13, 2022

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborators

Children's Hospital of Chongqing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03372525

Brief Title

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

Official Title

Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome (ARDS) and/or RDS : a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborators

Children's Hospital of Chongqing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HFOV

Arm Type

Experimental

Arm Description

Ventilated infants were randomized to HFOV.

Arm Title

CMV

Arm Type

Active Comparator

Arm Description

Ventilated infants were randomized to CMV.

Intervention Type

Device

Intervention Name(s)

HFOV

Intervention Description

Infants were randomized to HFOV

Intervention Type

Device

Intervention Name(s)

CMV

Intervention Description

Infants were randomized to CMV

Primary Outcome Measure Information:

Title

bronchopulmonary dysplasia (BPD)

Description

neonate was diagnosed with BPD

Time Frame

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

Title

death

Description

the included preterm infants were dead

Time Frame

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

Secondary Outcome Measure Information:

Title

air leak

Description

the included preterm infants were diagnosed with air leak

Time Frame

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

Title

the incidence of retinopathy of prematurity(ROP)

Description

the included preterm infants were diagnosed with ROP

Time Frame

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

Title

the incidence of neonatal necrotizing enterocolitis(NEC)

Description

the included preterm infants were diagnosed with NEC

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Minute

Maximum Age & Unit of Time

12 Hours

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Children's Hospital of Chongqing Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400042

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Long Chen, MD

Phone

8613883559467

neuroclong@126.com

First Name & Middle Initial & Last Name & Degree

Shi Yuan, PhD,MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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