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

Respiratory Distress Syndrome Clinical Trial

Official title:

Principal Investigator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496508
• Other study ID #: ZZ-HFOV
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2011
• Last updated: December 20, 2011
• Start date: June 2007
• Est. completion date: June 2011

Study information

• Verified date: December 2011
• Source: Zhengzhou Children's Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	Zhengzhou Children's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhengzhou Children's Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of bronchopulmonary dysplasia	To count the number of patients with bronchopulmonary dysplasia at 36 weeks of postmenstrual age.	defined as requirement of oxygen at 36 weeks of postmenstrual age	Yes
Secondary	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.	number of days on mechanical ventilation after birth to 36weeks of postmenstrual age	Yes