Comparison of the effect of (NSIMV) Nasal Synchronized Intermittent Mandatory Ventilation whit (NHFOV) Nasal high frequency oscillatory ventilation in neonates requiring non-invasive mechanical ventilation in Mofid Pediatric Hospital

Phase 2

Conditions: Respiratory Distress Syndrome/ Prematurity.
Respiratory distress of newborn

Registration Number: IRCT20221120056556N1

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 180

Inclusion Criteria

Inclusion criteria include: Premature babies hospitalized in the intensive care unit with a gestational age of more than 26 weeks who need respiratory support.
Informed consents of the baby's parents

Exclusion Criteria

Babies who were intubated for resuscitation or for another reason before randomization.
cardio-pulmonary arrest requiring prolonged resuscitation
lack of consent of the baby's parents
Transferring the baby out of the neonatal intensive care unit before randomization
In infants with the contraindication of non-invasive mechanical ventilation, such as infants with esophageal atresia or diaphragmatic hernia within 10 to 14 days after surgery
Babies with head and face anomalies that do not allow ventilation inside the baby's nose, such as cleft lip and palate
Intraventricular hemorrhage in grade 3 and 4

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of need for mechanical ventilation in premature infants under study. Timepoint: In the total hospitalization time of the premature baby under study in the neonatal intensive care unit. Method of measurement: The number of days without the need for mechanical ventilation in the baby.

Secondary Outcome Measures

Name	Time	Method
Patent ductus arteriosus. Timepoint: During the hospitalization of the baby. Method of measurement: Echocardiography by pediatric cardiologist.;Retinopathy of permaturity. Timepoint: During the hospitalization of the baby. Method of measurement: By Ophthalmologist retina subspecialties.;Intraventricular hemorrhage. Timepoint: During the hospitalization of the baby. Method of measurement: Brain sonography by pediatric radiologist.;Necrotizing enterocollitis. Timepoint: During the hospitalization of the baby. Method of measurement: Clinical sings according to BELL score and abdominal sonography by pediatric radiologist.;Bronchopulmonary dysplasia. Timepoint: During the hospitalization of the baby. Method of measurement: Clinical signs and radiologic findings.