NCT05592431

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

October 27, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

October 20, 2022

Last Update Submit

September 23, 2024

Conditions

Infant, Premature, DiseasesRespiratory Tract DiseasesCerebral Blood Flow

Keywords

High Frequency Oscillatory VentilationVolume Guarantee-High Frequency Oscillatory VentilationPretermCerebral Blood Flow

Outcome Measures

Primary Outcomes (1)

  • Doppler cerebral blood flow velocity measurements

    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

    72 hours

Secondary Outcomes (6)

  • efficiency of HFOV-VG in comparison with HFOV alone

    8 weeks or till patient discharged

  • Duration of admission

    8 weeks or till patient discharged

  • Mortality rate

    8 weeks or till patient death which comes first

  • Incidence of feeding intolerance

    8 weeks or till patient discharged

  • Days to reach full intake

    8 weeks or till patient discharge which comes first

  • +1 more secondary outcomes

Study Arms (2)

High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG )

EXPERIMENTAL

After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV-VG ) will be assessed by doppler cerebral blood flow velocity measurements

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

High Frequency Oscillatory Ventilation (HFOV)

ACTIVE COMPARATOR

After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV) will be assessed by doppler cerebral blood flow velocity measurements

Device: High Frequency Oscillatory Ventilation (SLE6000;SLE)

Interventions

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).

Also known as: transcranial Doppler ultrasonographic examination
High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG )
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

Also known as: transcranial Doppler ultrasonographic examination
High Frequency Oscillatory Ventilation (HFOV)

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Units (NICUs), Ain Shams University

Cairo, Abbasia, 11517, Egypt

Location

MeSH Terms

Conditions

Infant, Premature, DiseasesRespiratory Tract DiseasesPremature Birth

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 24, 2022

Study Start

October 27, 2022

Primary Completion

May 30, 2024

Study Completion

August 30, 2024

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)