Nasal High Frequency in Preterm Neonates

NCT06687083 | Completed

• 1 other identifier: nasal high frequency neonates
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

One of the most commonly used non-invasive methods is nasal continuous positive airway pressure (nCPAP). Although high frequency ventilation (HFV) has been applied in many neonatal intensive care units, nasal high frequency oscillatory ventilation (nHFOV) is a relatively new non-invasive modality. The application of nasal high-frequency ventilation with the strategy of lung recruitment will combine benefits of improving gas exchange and decreasing lung injury together with avoiding complication of invasive ventilation.

Conditions

Respiratory Distress Syndrome (RDS); Neonatal Diseases and Abnormalities

Keywords

preterm neonate; non invasive ventilation; high frequency ventilation; respiratory distress

Outcome Measures

Primary Outcomes (1)

• need for invasive mechanical ventilation

  five days

Secondary Outcomes (2)

• duration of respiratory support

  one month

• mortality

  one month

Study Arms (2)

nasal high frequency

EXPERIMENTAL

Preterm neonates who will be allocated will start nHFOV. nHFOV will be provided via binasal prongs (Size: small, medium, large; Diameter according to its chart. The initial parameters will be mean airway pressure (MAP) of 6 cm H2O (range 6-10), frequency of 8 Hz (range 8-12) and amplitude will be adjusted until infant's chest showed slight oscillations and amplitude will be 7 (range 7-10). The fraction of inspired oxygen (FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter

Device: nasal high frequency oscillatory ventilation mode

nasal CPAP

ACTIVE COMPARATOR

Preterm neonates who will be allocated to this group to the nCPAP will be started on a pressure of 6-8 cm H2O, FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter.

Drug: nasal continuous positive pressure ventilation mode

Interventions

nasal high frequency oscillatory ventilation mode DEVICE

Preterm neonates who will be allocated will start nHFOV: (CNO, Medin, Germany). nHFOV will be provided via binasal prongs (Size: small, medium, large; Diameter according to its chart; Medin, Germany). The initial parameters will be mean airway pressure (MAP) of 6 cm H2O (range 6-10), frequency of 8 Hz (range 8-12) and amplitude will be adjusted until infant's chest showed slight oscillations and amplitude will be 7 (range 7-10). The fraction of inspired oxygen (FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter.

nasal high frequency

nasal continuous positive pressure ventilation mode DRUG

Preterm neonates who will be allocated to this group to the nCPAP will be started on a pressure of 6-8 cm H2O, FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter

nasal CPAP

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age: 30-34 weeks (determined by date of last menstrual period or ultrasound) and confirmed by Ballard score.
• Recruited immediately after birth Up to 24 hours of age.
• Appropriate weight for the gestational age.
• Spontaneous breathing and clinical signs and symptoms of respiratory distress syndrome (grunting, cyanosis, intercostal and subcostal retractions) or RDS Silverman Score \> 5.

You may not qualify if:

• Major congenital abnormalities, congenital heart disease and diaphragmatic hernia.
• A need for intubation and mandatory ventilation during resuscitation or on the first day of life.
• Perinatal asphyxia (Umbilical cord pH \< 7.16, and umbilical cord bicarbonate \< 12 mEq/L)
• Pulmonary hemorrhage and severe intraventricular hemorrhage (IVH) on admission.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (2)

• Diblasi RM. Nasal continuous positive airway pressure (CPAP) for the respiratory care of the newborn infant. Respir Care. 2009 Sep;54(9):1209-35.

  PMID: 19712498 BACKGROUND

• Aktas S, Unal S, Aksu M, Ozcan E, Ergenekon E, Turkyilmaz C, Hirfanoglu I, Atalay Y. Nasal HFOV with Binasal Cannula Appears Effective and Feasible in ELBW Newborns. J Trop Pediatr. 2016 Apr;62(2):165-8. doi: 10.1093/tropej/fmv088. Epub 2015 Dec 27.

  PMID: 26710797 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyspnea

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of pediatrics

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: July 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2023
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)