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

NCT06737003 | Completed FDA Device

• 1 other identifier: Hemodynamic ,noninvasive
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hemodynamic; Noninvasive; Respiratory Support; Preterms

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of NHFOV and Hi-VNI Vapotherm in comparison to nasal CPAP as a primary noninvasive respiratory support in preterm neonates

  By Assessment of the need for invasive mechanical ventilation (IMV) during the first 72 hours after enrollment in one of the groups.

  1year

Secondary Outcomes (3)

• Assessment of right ventricular output (RVO)in ml/kg/min, left ventricular output (LVO) in ml/kg/min, and superior vena cava (SVC) flow in ml/kg/min,one hour before and one hour after discontinuation of noninvasive respiratory support.

  1 year

• Assessment of cerebral blood flow in ml/kg/min ,one hour before and one hour after discontinuation of noninvasive respiratory support.

  1 year

• Assessment of pre-prandial superior mesenteric artery (SMA) velocity and volume of flow in ml/kg/min ,one hour before and one hour after discontinuation of noninvasive respiratory support.

  1 year

Study Arms (3)

NHFOV group

ACTIVE COMPARATOR

Nasal high frequency oscillatory ventilation (NHFOV) will be delivered by; SLE 6000 device, Wipro GE Healthcare Private Limited, Bengaluru, Karnataka. Amplitude range (20:35), frequency range (8-12)HZ, Mean air way pressure(MAP) range (6: 10) cmH2O and Inspiration :Expiration (I:E) ratio 1:1 may change to 1:2 in case of air trapping .

Device: Nasal high frequency oscillatory ventilation

Vapotherm group

ACTIVE COMPARATOR

Vapotherm will be delivered by; Vapotherm device,Vapotherm,INC,USA. The recommended starting flow rate is 4-6 L/min. To be titrated to clinical effect to maximum of 8 L/min as needed,with temperature 36-37°C andFraction of inspired oxygen (FiO2) titrated as needed to achieve target Saturation of peripheral oxygen (SpO2)(90% to 94%).

Device: Vapotherm Group

Standard noninvasive mechanical ventilation group (CPAP)

ACTIVE COMPARATOR

CPAP will be delivered by; MEDIN CNO device, medin Medical Innovations GmbH, Olching, Germany . Pressure ranging from 5 to 8 cm H2O,to maintain SpO2 from 90% to 94%.

Device: Nasal CPAP Group

Interventions

Nasal high frequency oscillatory ventilation DEVICE

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 •

NHFOV group

Vapotherm Group DEVICE

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

Vapotherm group

Nasal CPAP Group DEVICE

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

Standard noninvasive mechanical ventilation group (CPAP)

Eligibility Criteria

• Age: 25 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates with gestational age ≤ 35 weeks with RDS that need noninvasive ventilatory support primarily.

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)

Ainshams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rania el farrash

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: A randomized controlled study on 90 preterm neonates with Respiratory distress syndrome(RDS) in need for noninvasive ventilation during their first 3 days of life. They were randomized into 3 groups; Nasal high frequency oscillatory ventilation (NHFOV),Vapotherm and Continuous positive air way pressure(CPAP) groups; 30 neonates for each group. Haemodynamic changes were assessed by echocardiography, pelviabdominal and transcranial ultrasounds during and after discontinuation of device .

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: December 17, 2024
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 17, 2024

Record last verified: 2024-11

Locations

EG (1)