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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221120056556N1
Enrollment
180
Registered
2023-01-24
Start date
2023-02-20
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome/ Prematurity. Respiratory distress of newborn

Interventions

Intervention group: Premature babies with a gestational age of more than 26 weeks need non-invasive mechanical ventilation.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 30 Days

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactminoo fallahi

Shahid Beheshti University of Medical Sciences

minou_fallahi@sbmu.ac.ir+98 21 2292 2828

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026