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Completed

NCT Number: NCT01496508

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

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.

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Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Tract Diseases

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhengzhou Children's Hospital

Zhengzhou, Henan, 450003, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mechanical ventilation (SLE 5000, Servo-i-Maquet)

Device

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: conventional mechanical ventilation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Zhengzhou Children's Hospital, China

Other

Registry information

Official study title

Principal Investigator

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Dec 21, 2011
Registry last updated
Dec 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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