Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates

NCT05493527 | Unknown

• 1 other identifier: MD 90/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory distress syndrome(RDS)

Conditions

Infant, Premature, Diseases; Infant, Newborn, Disease; Respiratory Tract Diseases; RDS

Keywords

noninvasive high frequency ventilation; noninvasive ventilation; RDS; post-extubation; preterm; respiratory distress syndrome; noninvasive positive pressure ventilation

Outcome Measures

Primary Outcomes (1)

• Re-intubation rate

  Percentage of Patients who failed weaning on the assigned noninvasive mode and needed reintubation to the total number of patients assigned to that mode.

  72 hours

Secondary Outcomes (16)

• Days on the assigned non-invasive respiratory support

  8 weeks or till patient discharge which comes first

• Days on supplemental oxygen

  8 weeks or till patient discharge which comes first

• Duration of admission

  8 weeks or till patient discharge which comes first

• Mortality rate

  8 weeks or till patient death which comes first

• Lung ultrasound score

  Before extubation and after 2 hours on assigned mode

Study Arms (2)

noninvasive high frequency oscillatory ventilation (NHFOV)

EXPERIMENTAL

After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NHFOV as post extubation noninvasive respiratory support

Device: noninvasive high frequency oscillatory ventilation

noninvasive positive pressure ventilation (NIPPV)

ACTIVE COMPARATOR

After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NIPPV as post extubation noninvasive respiratory support

Device: noninvasive positive pressure ventilation

Interventions

noninvasive high frequency oscillatory ventilation DEVICE

A time-cycled, pressure-limited, and continuous-flow neonatal ventilator (SLE6000; SLE) was used for neonates assigned to the NHFOV group. The settings were as follows: 1. a frequency of 10 Hertz ( range, 8-12 Hz); 2. an inspiratory time of 50% (1:1) 3. an oscillation amplitude of 35 centimeter of water column (cmH2O) (subsequent regulation range, 20-40 cmH2O) Oscillation amplitude would be regulated according to the level of carbon dioxide(CO2). Visible chest oscillation was not necessary because elimination of CO2 during NHFOV could also occur in the upper respiratory airway dead space 4. Mean airway pressure (MAP) of 10 cm H2O ( range, 7-15) MAP was regulated according to an open lung recruitment strategy 5. fraction of inspired oxygen (FIO2) regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.

noninvasive high frequency oscillatory ventilation (NHFOV)

noninvasive positive pressure ventilation DEVICE

NIPPV will be delivered by ventilator generating the targeted pressures. Infants will be on: 1. Peep ranging from 5 to 10 cmH2O, 2. Peak inspiratory pressure range 15-25 cmH2O 3. Rate range 40-50 breath/minute 4. FIO2 regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.

noninvasive positive pressure ventilation (NIPPV)

Eligibility Criteria

• Age: 1 Minute - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates with gestational age ≤ 35 weeks.
• Neonates that were on invasive mechanical ventilation for at least 48 hours eligible for extubation

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Neonatal Intensive Care Units (NICUs), Ain Shams University

Cairo, Abbasia, 11517, Egypt

RECRUITING

MeSH Terms

Conditions

Infant, Premature, Diseases; Disease; Respiratory Tract Diseases; Premature Birth; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiration Disorders

Central Study Contacts

Sondos Ahmed

CONTACT

0109440704; sondosahmedsalah@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 9, 2022
• Study Start: February 1, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 30, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

EG (1)