Clinical trial NCT01496508: High-frequency Oscillatory Ventilation (HFOV) in Preterm Infants With Severe Respiratory Distress Syndrome (RDS)
Official title: Principal Investigator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Distress Syndrome
Keywords: high-frequency oscillatory ventilation
respiratory distress syndrome
preterm infants
neurodevelopment
preterm infants with severe respiratory distress syndrome
Lead sponsor: Zhengzhou Children's Hospital, China
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 360
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Incidence of bronchopulmonary dysplasia
timeFrame: defined as requirement of oxygen at 36 weeks of postmenstrual age
Secondary outcomes:
measure: duration of mechanical ventilation
timeFrame: number of days on mechanical ventilation after birth to 36weeks of postmenstrual age
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zhengzhou Children's Hospital
state: Henan
Study officials:
affiliation: Zhengzhou Children's Hospital
name: Hong Xiong, MD
role: STUDY_DIRECTOR
References:
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.