Respiratory Tract Diseases Clinical Trial
Official title:
Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Preterm Neonates: A Randomized Controlled Trial
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)
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 30, 2022 |
Est. primary completion date | August 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Minute to 1 Month |
Eligibility | Inclusion Criteria: 1. Preterm neonates with gestational age = 35 weeks. 2. Neonates that were on invasive mechanical ventilation for at least 48 hours eligible for extubation Exclusion Criteria: 1. Patients with major upper or lower airway anomalies. 2. Patients with significant congenital anomalies including cardiac, abdominal or respiratory. |
Country | Name | City | State |
---|---|---|---|
Egypt | Neonatal Intensive Care Units (NICUs), Ain Shams University | Cairo | Abbasia |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Days on the assigned non-invasive respiratory support | To document number of days on the assigned non-invasive respiratory support | 8 weeks or till patient discharge which comes first | |
Secondary | Days on supplemental oxygen | To document number of days on supplemental oxygen | 8 weeks or till patient discharge which comes first | |
Secondary | Duration of admission | To document total number of days of admission | 8 weeks or till patient discharge which comes first | |
Secondary | Mortality rate | To document incidence of mortality during hospitalization | 8 weeks or till patient death which comes first | |
Secondary | Lung ultrasound score | lung ultrasound was performed to all patients before extubation and 2 hours after extubation to assess lung aeration. Score ranges from 0 to 18 .Higher score indicates worse lung aeration. | Before extubation and after 2 hours on assigned mode | |
Secondary | Co2 change | Co2 change in patients on assigned mode using venous blood gases performed before extubation and 2 hours after. | Before extubation and after 2 hours on assigned mode | |
Secondary | Oxygen requirement | Fraction of inspired oxygen required to patients on assigned mode | Before extubation and after 2 hours on assigned mode | |
Secondary | Incidence of feeding intolerance | Percentage of Patients who developed feeding intolerance on the assigned noninvasive mode to the total number of patients assigned to that mode. | 8 weeks or till patient weaning from assigned mode which comes first | |
Secondary | Days to reach full intake | Number of days needed by each patient to reach full intake | 8 weeks or till patient discharge which comes first | |
Secondary | Intracranial hemorrhage | Percentage of patients developing intracranial hemorrhage on the assigned noninvasive mode to the total number of patients assigned to that mode. | 8 weeks or till patient weaning from assigned mode which comes first | |
Secondary | Pneumothorax | Percentage of patients developing pneumothorax on the assigned noninvasive mode to the total number of patients assigned to that mode. | 8 weeks or till patient weaning from assigned mode which comes first | |
Secondary | Incidence of occurrence of Nasal trauma | Percentage of patients developing nasal trauma on the assigned noninvasive mode to the total number of patients assigned to that mode. | 8 weeks or till patient weaning from assigned mode which comes first | |
Secondary | incidence of bronchopulmonary dysplasia | Need for supplemental oxygen for at least 28 days, percentage of these patients on the assigned noninvasive mode to the total number of patients assigned to that mode. | 8 weeks or till patient discharge which comes first | |
Secondary | Severity of respiratory distress | Assessment of work of breathing on assigned mode by Downe 's score. Score ranges from 0 till 10 . Higher score indicates worse work of breathing. | Before extubation and and after 2 hours on assigned mode | |
Secondary | Need for Postnatal Steroids | Percentage of patients who needed postnatal steroids administration | 8 weeks or till patient discharge which comes first | |
Secondary | Chest x ray change | Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree. | Before extubation and and after 2 hours on assigned mode |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
Withdrawn |
NCT04842331 -
PREvent Viral Exposure and Transmission Study: a COVID-19 (SARS-CoV-2) PEP Study (PREVENT)
|
Phase 2/Phase 3 | |
Completed |
NCT02352168 -
Airway Inflammation in Children With Allergic Rhinitis and Intervention
|
N/A | |
Completed |
NCT01860898 -
A Phase I Study of iPS Cell Generation From Patients With COPD
|
N/A | |
Completed |
NCT00984945 -
Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults
|
Phase 1 | |
Completed |
NCT00382408 -
A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
|
Phase 3 | |
Completed |
NCT01442779 -
Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
Recruiting |
NCT05907564 -
Aventus Thrombectomy System Pulmonary Embolism Clinical Study
|
N/A | |
Not yet recruiting |
NCT05534685 -
Budesonia + Intratracheal Surfactant in Incidence of Bronchopulmonary Dysplasia
|
N/A | |
Completed |
NCT03739112 -
Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly
|
Phase 3 | |
Active, not recruiting |
NCT04170348 -
Daily Vitamin D for Sickle-cell Respiratory Complications
|
Phase 2 | |
Completed |
NCT05056766 -
How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement
|
||
Completed |
NCT01991587 -
Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults
|
Phase 1/Phase 2 | |
Recruiting |
NCT05565872 -
Effects of Supervision During a Community-based Exercise Intervention (Urban Training) in Patients With COPD
|
N/A | |
Not yet recruiting |
NCT05592431 -
Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates
|
N/A | |
Completed |
NCT03401463 -
Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar
|
N/A | |
Recruiting |
NCT02913365 -
Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis
|
N/A | |
Active, not recruiting |
NCT01055990 -
Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients
|
Phase 2 | |
Completed |
NCT00743990 -
Effect of Effect of a Medicated Topical Therapy , Petrolatum, and No Treatment on Nocturnal Cough
|
N/A | |
Completed |
NCT02198391 -
Study of Echinaforce Junior Tablets in Children With Acute Colds
|