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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Changlian Zhu, Zhengzhou Children's Hospital, China
ClinicalTrials.gov Identifier:
NCT01496508
First received: December 13, 2011
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome
Device: mechanical ventilation (SLE 5000, Servo-i-Maquet)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Principal Investigator

Resource links provided by NLM:


Further study details as provided by Zhengzhou Children's Hospital, China:

Primary Outcome Measures:
  • Incidence of bronchopulmonary dysplasia [ Time Frame: defined as requirement of oxygen at 36 weeks of postmenstrual age ] [ Designated as safety issue: Yes ]
    To count the number of patients with bronchopulmonary dysplasia at 36 weeks of postmenstrual age.


Secondary Outcome Measures:
  • duration of mechanical ventilation [ Time Frame: number of days on mechanical ventilation after birth to 36weeks of postmenstrual age ] [ Designated as safety issue: Yes ]
    To calculate how many days of the newborn baby with mechanical ventilation either HFOV or CV at 36 weeks postmenstrual age.


Enrollment: 360
Study Start Date: June 2007
Study Completion Date: June 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: mechanical ventilation (SLE 5000, Servo-i-Maquet)
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 Name: conventional mechanical ventilation
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.
Device: mechanical ventilation (SLE 5000, Servo-i-Maquet)
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 Name: conventional mechanical ventilation

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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01496508

Locations
China, Henan
Zhengzhou Children's Hospital
Zhengzhou, Henan, China, 450003
Sponsors and Collaborators
Zhengzhou Children's Hospital, China
Investigators
Study Director: Hong Xiong, MD Zhengzhou Children's Hospital
  More Information

No publications provided by Zhengzhou Children's Hospital, China

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Changlian Zhu, Professor, Zhengzhou Children's Hospital, China
ClinicalTrials.gov Identifier: NCT01496508     History of Changes
Other Study ID Numbers: ZZ-HFOV
Study First Received: December 13, 2011
Last Updated: December 20, 2011
Health Authority: China: Ministry of Health

Keywords provided by Zhengzhou Children's Hospital, China:
high-frequency oscillatory ventilation
respiratory distress syndrome
preterm infants
neurodevelopment
preterm infants with severe respiratory distress syndrome

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 18, 2014