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NCT Number: NCT05592431

Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates

A randomized controlled clinical trial evaluates cerebral blood flow changes associated with HFOV-VG in comparison to HFOV alone in preterm neonates with respiratory insufficiency during the period of invasive respiratory support

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Key information

Conditions

Infant, Premature, Diseases Cerebral Blood Flow Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal Intensive Care Units (NICUs), Ain Shams University

Cairo, Abbasia, 11517, Egypt

About this study

Neonatal respiratory distress (NRD) is one of the most common problems in the first few days of neonatal life. NRD has been reported to be prevalent in 5 - 29% of the NICU hospitalized neonates.

High-frequency oscillatory ventilation (HFOV) has been used for more than three decades, it is a rescue maneuver for failed conventional mechanical ventilation. It delivers small tidal volumes to improve gas exchange. As it uses a low tidal volume, under the anatomical dead space at supra-physiological respiratory frequencies HFOV can reduce the risk of lung injury related to the ventilator and consequently reduce the risk of bronchopulmonary dysplasia HFOV is indicated for patients with neonatal air leak syndrome, persistent pulmonary hypertension, and meconium aspiration Several factors are known to influence cerebral perfusion during HFOV. Hypercapnia increases cerebral blood flow (CBF) while a reduction in PaCO2 leads to cerebral vasoconstriction and decreases CBF, Hypoxia is also known to increase CBF via cerebral vasodilation HFOV with volume guarantee (HFOV-VG) is a promising new ventilator mode for the treatment of respiratory failure in newborns. HFOV-VG is expected to result in less lung injury since it reduces fluctuations of high frequency tidal volume (VThf), reduces the number of out-of-target pCO2 values and provides fewer hypoxia attacks compared with HFOV alone

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Preterm neonates with gestational age ≤ 35 weeks.
  • Neonates with various causes of respiratory failure: respiratory distress syndrome (RDS), air leak syndromes, pneumonia, or pulmonary hemorrhage, failing with conventional ventilation (i.e. when conventional ventilation failed to maintain either oxygenation or ventilation) and are switched to HFOV as a rescue therapy.

Exclusion criteria

  • Preterm neonates with major upper or lower airway anomalies.
  • Preterm neonates with significant congenital anomalies including cardiac, abdominal or respiratory

Treatment and study plan

High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE)

Device

ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P and high-frequency tidal volume (VThf).

Other names: transcranial Doppler ultrasonographic examination

High Frequency Oscillatory Ventilation (SLE6000;SLE)

Device

ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P

Other names: transcranial Doppler ultrasonographic examination

Primary outcomes

  1. Doppler cerebral blood flow velocity measurements

    Time frame: 72 hours

    Investigate the effect of combining the VG mode with HFOV (HFOV-VG), versus the effect of HFOV alone, on Doppler cerebral blood flow velocity measurements

Secondary outcomes

  1. efficiency of HFOV-VG in comparison with HFOV alone

    Time frame: 8 weeks or till patient discharged

    Evaluate the efficiency of HFOV-VG in comparison with HFOV alone as a rescue therapy in providing adequate neonatal ventilation and its possible impact on the short-term clinical outcome in terms of mortality and morbidities of these preterm neonates.

  2. Duration of admission

    Time frame: 8 weeks or till patient discharged

    To document total number of days of admission

  3. Mortality rate

    Time frame: 8 weeks or till patient death which comes first

    To document incidence of mortality during hospitalization

  4. Incidence of feeding intolerance

    Time frame: 8 weeks or till patient discharged

    Percentage of Patients who developed feeding intolerance

  5. Days to reach full intake

    Time frame: 8 weeks or till patient discharge which comes first

    Number of days needed by each patient to reach full intake

  6. Chest x ray change

    Time frame: Before intubation and and after 2 hours on assigned mode

    Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Preterm Neonates

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2022
Registry last updated
Sep 25, 2024

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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