search
Back to results

High-frequency Oscillatory Ventilation (HFOV) in Preterm Infants With Severe Respiratory Distress Syndrome (RDS)

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
mechanical ventilation (SLE 5000, Servo-i-Maquet)
Sponsored by
Zhengzhou Children's Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Distress Syndrome focused on measuring high-frequency oscillatory ventilation, respiratory distress syndrome, preterm infants, neurodevelopment, preterm infants with severe respiratory distress syndrome

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Preterm infants admitted to the NICU with gestational age <32 weeks, birth weight <1500g and less than 24 hours of age
  2. Who developed RDS requiring mechanical ventilation
  3. Presented a partial pressure of oxygen (PaO2): fraction of inspired oxygen (FIO2) ratio <200
  4. Radiograph criteria of severe RDS

Exclusion Criteria:

  1. Infants with genetic metabolic diseases
  2. Congenital abnormalities
  3. Pneumothorax
  4. Grade III-IV intracranial hemorrhage

Sites / Locations

  • Zhengzhou Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HFOV

CV

Arm Description

A SLE5000 infant ventilator was used as the high-frequency ventilator.HFOV setting were as follows: initial frequency was set between 11 and 15Hz; pressure amplitude of oscillation was initially adjusted to provide adequate chest wall movement and was subsequently titrated to maintain the PaCO2 between 40 and 55 mmHg.Extubation was considered when the patient's condition was stable for 12-24h, while adequate oxygenation could be maintained with an FIO2 <0.3 and respiratory rate <25/min.

A Servo-i-Maquet will be used as the conventional mechanical ventilator. CV settings were: exhaled tidal volumes set at 5-6 mL/kg, initial peak inspiratory pressure (PIP) of 15-25 cmH2O; positive expiratory end pressure (PEEP) set to 4-6 cmH2O; inspiratory times of 0.25-0.40s; rates set to <60/min. The weaning process was initiated when the following parameters were achieved: PIP <18 cmH2O, PEEP <4 cmH2O, and FIO2 <0.4. Extubation was considered when the patient's condition was stable for 12-24h, while adequate oxygenation could be maintained with an FIO2 <0.3 and respiratory rate <25/min. All infants extubated onto nasal continuous positive airway pressure (Infant Flow, Electro Medical Equipment) and then weaned to a nasal cannula, and then to room air.

Outcomes

Primary Outcome Measures

Incidence of bronchopulmonary dysplasia
To count the number of patients with bronchopulmonary dysplasia at 36 weeks of postmenstrual age.

Secondary Outcome Measures

duration of mechanical ventilation
To calculate how many days of the newborn baby with mechanical ventilation either HFOV or CV at 36 weeks postmenstrual age.

Full Information

First Posted
December 13, 2011
Last Updated
December 20, 2011
Sponsor
Zhengzhou Children's Hospital, China
search

1. Study Identification

Unique Protocol Identification Number
NCT01496508
Brief Title
High-frequency Oscillatory Ventilation (HFOV) in Preterm Infants With Severe Respiratory Distress Syndrome (RDS)
Official Title
Principal Investigator
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhengzhou Children's Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Respiratory distress syndrome (RDS) is common in preterm infants born at less than 32 weeks gestation; surfactant and mechanical ventilation have been the standard treatment. However, despite advances in neonatal respiratory care, a considerable number of preterm infants develop chronic lung disease, termed bronchopulmonary dysplasia (BPD), which is associated with neonatal death, prolonged neonatal intensive care stay, and impaired neurodevelopment. High-frequency oscillatory ventilation (HFOV) was developed as a new ventilation technique in the late 1970s. It was expected to result in less BPD and death as a primary model of ventilation compared to conventional ventilation (CV) in the treatment of RDS. However, there is disagreement concerning the advantage of HFOV over CV in the treatment of RDS in preterm infants regarding the prevention of death, BPD, intraventricular hemorrhage, and periventricular leucomalacia in the short term. The purpose of this study was to compare the efficacy and safety of HFOV and CV in preterm infants with severe RDS.
Detailed Description
All patients were monitored including blood pressure, heart rate, oxygen saturation, ventilator settings, and arterial blood gases pre- or during mechanical ventilation. PaO2/FIO2 was calculated. After 2 hours ventilation, if PaO2/FIO2 <200, patients were given rescue surfactant therapy (Curosurf 200mg/kg). A subsequent dose (100mg/kg) was administered when PaO2/FIO2 <200 12 hours after the previous dose. Surfactant was administered with use of in-line catheters. Suctioning was performed 6 hours after surfactant administration, except for some patients needed suction soon, with use of an in-line suction catheter. Ventilation continued during the administration of surfactant and suctioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
high-frequency oscillatory ventilation, respiratory distress syndrome, preterm infants, neurodevelopment, preterm infants with severe respiratory distress syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFOV
Arm Type
Experimental
Arm Description
A SLE5000 infant ventilator was used as the high-frequency ventilator.HFOV setting were as follows: initial frequency was set between 11 and 15Hz; pressure amplitude of oscillation was initially adjusted to provide adequate chest wall movement and was subsequently titrated to maintain the PaCO2 between 40 and 55 mmHg.Extubation was considered when the patient's condition was stable for 12-24h, while adequate oxygenation could be maintained with an FIO2 <0.3 and respiratory rate <25/min.
Arm Title
CV
Arm Type
Experimental
Arm Description
A Servo-i-Maquet will be used as the conventional mechanical ventilator. CV settings were: exhaled tidal volumes set at 5-6 mL/kg, initial peak inspiratory pressure (PIP) of 15-25 cmH2O; positive expiratory end pressure (PEEP) set to 4-6 cmH2O; inspiratory times of 0.25-0.40s; rates set to <60/min. The weaning process was initiated when the following parameters were achieved: PIP <18 cmH2O, PEEP <4 cmH2O, and FIO2 <0.4. Extubation was considered when the patient's condition was stable for 12-24h, while adequate oxygenation could be maintained with an FIO2 <0.3 and respiratory rate <25/min. All infants extubated onto nasal continuous positive airway pressure (Infant Flow, Electro Medical Equipment) and then weaned to a nasal cannula, and then to room air.
Intervention Type
Device
Intervention Name(s)
mechanical ventilation (SLE 5000, Servo-i-Maquet)
Other Intervention Name(s)
conventional mechanical ventilation
Intervention Description
Ventilation strategies for both groups were to emphasize lung recruitment and avoid atelectasis and over distention. The optimum lung volume was determined as expansion to 8 to 9.5 ribs for most infants, and 7 to 8 ribs for infants with air leak. HFOV setting were as follows: initial frequency was set between 11 and 15Hz; pressure amplitude of oscillation was initially adjusted to provide adequate chest wall movement and was subsequently titrated to maintain the PaCO2 between 40 and 55 mmHg; The initial mean airway pressure (MAP) was set at 8-10 cmH2O. MAP and FIO2 were set to maintain arterial oxygen saturation between 88 to 95%, an arterial pH of at least 7.25. Extubation was considered when MAP was ≤7 cmH2O and the pressure amplitude of oscillation reach 10 to 15 cmH2O.
Primary Outcome Measure Information:
Title
Incidence of bronchopulmonary dysplasia
Description
To count the number of patients with bronchopulmonary dysplasia at 36 weeks of postmenstrual age.
Time Frame
defined as requirement of oxygen at 36 weeks of postmenstrual age
Secondary Outcome Measure Information:
Title
duration of mechanical ventilation
Description
To calculate how many days of the newborn baby with mechanical ventilation either HFOV or CV at 36 weeks postmenstrual age.
Time Frame
number of days on mechanical ventilation after birth to 36weeks of postmenstrual age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm infants admitted to the NICU with gestational age <32 weeks, birth weight <1500g and less than 24 hours of age Who developed RDS requiring mechanical ventilation Presented a partial pressure of oxygen (PaO2): fraction of inspired oxygen (FIO2) ratio <200 Radiograph criteria of severe RDS Exclusion Criteria: Infants with genetic metabolic diseases Congenital abnormalities Pneumothorax Grade III-IV intracranial hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Xiong, MD
Organizational Affiliation
Zhengzhou Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhengzhou Children's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23764865
Citation
Sun H, Cheng R, Kang W, Xiong H, Zhou C, Zhang Y, Wang X, Zhu C. High-frequency oscillatory ventilation versus synchronized intermittent mandatory ventilation plus pressure support in preterm infants with severe respiratory distress syndrome. Respir Care. 2014 Feb;59(2):159-69. doi: 10.4187/respcare.02382. Epub 2013 Jun 13.
Results Reference
derived

Learn more about this trial

High-frequency Oscillatory Ventilation (HFOV) in Preterm Infants With Severe Respiratory Distress Syndrome (RDS)

We'll reach out to this number within 24 hrs