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Haemodynamic Changes With Different Noninvasive Respiratory Modes for Primary Respiratory Support in Preterm Neonates

NCT06737003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-12-17

No results posted yet for this study

Summary

to evaluate the efficacy of Nasal high frequency oscillatory ventilation (NHFOV) and Vapotherm in comparison to nasal Continuous positive airway pressure (CPAP) as a primary noninvasive respiratory support in preterm neonates

Conditions

  • Ventilation

Interventions

DEVICE

Nasal high frequency oscillatory ventilation

NHFOV was administered using the SLE 6000 device manufactured by Wipro GE Healthcare Private Limited in Bengaluru, Karnataka. The initial amplitude was set at 25 cm H2O and adjusted to a maximum of 35 cm H2O based on clinical response. The frequency was set at 12 Hz. The mean airway pressure (MAP) was initiated at 6 cmH2O and titrated up to 10 cmH2O based on clinical assessment. The I:E ratio was maintained between 1:1 to 1:2 in cases of air trapping, using nasal prongs •

DEVICE

Vapotherm Group

The Hi-VNI Vapotherm was administered using the Vapotherm device, manufactured by Vapotherm, INC, USA. Initially, the flow rate was set at 4 L/min and adjusted accordingly to achieve the desired clinical outcome, with a maximum flow rate of 8 L/min when necessary. The temperature was maintained at 36-37°C, and the FiO2 was adjusted as required to attain the target SpO2 range of 90% to 94%، using soft nasal cannula interface

DEVICE

Nasal CPAP Group

CPAP therapy was administered using the MEDIN CNO device, developed by medin Medical Innovations GmbH in Olching, Germany. The initial pressure was set at 5 cmH2O and adjusted accordingly to achieve the desired clinical outcome, with a maximum pressure of 8 cmH2O. This approach aimed to maintain the target oxygen saturation (SpO2) levels between 90% and 94%، using bi-nasal with midline prongs

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Rania el farrash · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06737003 on ClinicalTrials.gov