- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01496508
High-frequency Oscillatory Ventilation (HFOV) in Preterm Infants With Severe Respiratory Distress Syndrome (RDS)
December 20, 2011 updated by: Changlian Zhu, Zhengzhou Children's Hospital, China
Principal Investigator
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
360
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Henan
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Zhengzhou, Henan, China, 450003
- Zhengzhou Children'S Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 day (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HFOV
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.
|
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.
Other Names:
|
Experimental: CV
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of bronchopulmonary dysplasia
Time Frame: defined as requirement of oxygen at 36 weeks of postmenstrual age
|
To count the number of patients with bronchopulmonary dysplasia at 36 weeks of postmenstrual age.
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defined as requirement of oxygen at 36 weeks of postmenstrual age
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of mechanical ventilation
Time Frame: number of days on mechanical ventilation after birth to 36weeks of postmenstrual age
|
To calculate how many days of the newborn baby with mechanical ventilation either HFOV or CV at 36 weeks postmenstrual age.
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number of days on mechanical ventilation after birth to 36weeks of postmenstrual age
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Hong Xiong, MD, Zhengzhou Children'S Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
December 13, 2011
First Submitted That Met QC Criteria
December 20, 2011
First Posted (Estimate)
December 21, 2011
Study Record Updates
Last Update Posted (Estimate)
December 21, 2011
Last Update Submitted That Met QC Criteria
December 20, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZZ-HFOV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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