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

NCT01496508 | Completed Phase 2 DMC

• 1 other identifier: ZZ-HFOV
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome

Keywords

high-frequency oscillatory ventilation; respiratory distress syndrome; preterm infants; neurodevelopment; preterm infants with severe respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• duration of mechanical ventilation

  number of days on mechanical ventilation after birth to 36weeks of postmenstrual age

Study Arms (2)

HFOV

EXPERIMENTAL

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)

CV

EXPERIMENTAL

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)

Interventions

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.

Also known as: conventional mechanical ventilation

CV; HFOV

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Infants with genetic metabolic diseases
• Congenital abnormalities
• Pneumothorax
• Grade III-IV intracranial hemorrhage

Sponsors & Collaborators

• Zhengzhou Children's Hospital, China: lead

Study Sites (1)

Zhengzhou Children's Hospital

Zhengzhou, Henan, 450003, China

Location

Related Publications (1)

• 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.

  PMID: 23764865 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Hong Xiong, MD

  Zhengzhou Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 21, 2011
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2011
• Last Updated: December 21, 2011

Record last verified: 2011-12

Locations

CN (1)