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."Effect of nasal continuous positive air way pressure on the clinical course of neonates with respiratory distress syndrome" ."Effect of nasal duo positive air way pressure on the clinical course of neonates with respiratory distress syndrome"

The effect of assisted ventilation using nasal continuous positive air way pressure versus nasal duo positive air way pressure on the clinical course of neonates with gestational age between 28-34 week with respiratory distress syndrome :A randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180821040847N1
Enrollment
148
Registered
2018-09-10
Start date
2018-09-23
Completion date
Unknown
Last updated
2019-05-21

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

Conditions

Respiratory distress syndrom. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group:The first group is neonates who are under nasal continuous positive air way pressure. fabian device from switzerland country , is used to apply this method. Interve

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Days

Inclusion criteria

Inclusion criteria: Preterm neonate with gestational age of 28-34 weeks With respiratory distress syndrome With respiratory distress syndrome score of 6-8 according to Silver man-Andersen score Entrance to study in primary 6 hours of birth

Exclusion criteria

Exclusion criteria: Major congenital abnormalities Air way abnormalities Sever cardio-vascular instability Sever asphyxia(Apgar score34 week Metabolic disorder Respiratory difficulties caused by nervous system disease or muscle disease cyanotic heart disease Birth at out of hospital studied

Design outcomes

Primary

MeasureTime frame
Non invasive ventilation failure that require intubation and mechanical ventilation during 72 hours after entrance to study. Timepoint: During the first 72 hours of admission to study. Method of measurement: The failure of treatment is considered to be when there are one or two of the following conditions.first condition included partial pressure of carbon dioxide in arterial blood >60 millimeter of mercury and potential hydrogen of arterial blood60% and positive end expiratory pressure >8 centimeters of water in method of nasal continuous positive air way pressure and duo pressure >15 centimeters of water and positive end expiratory pressure >8 centimeters of water and fraction of oxygen of >60% in method of nasal duo positive air way pressure .second condition included worsening of clinical conditions (increased respiratory distress by tachypnea and severe retraction of chest )or prolong apnea (apnea for more than 20 seconds )or repeated apnea for more than 2 time in 24 hours with cyanosis and bradycardi <100 beat in minute that require ventilation with bag and mask.

Secondary

MeasureTime frame
Intra ventricular hemorrhage. Timepoint: brain ultrasound performed by the radiologist on days 1 and 3 and 7 and 14 and 28 after admission. Method of measurement: By ultrasound of the brain performed by the radiologist.;Patent ductus arteriosus (A duct that establishes the connection between the pulmonary artery and the aorta that after birth,it is naturally closed and failure in this will result in patent ductus arteriosus). Timepoint: During the first 48 hours of birth or presence of clinical symptoms of patent ductus arteriosus like hearing asystolic murmur or hypotension. Method of measurement: Echocardiography is done by the pediatric cardiologist.;Chronic lung disease(oxygen dependence at gestational age 36 weeks). Timepoint: Up to 36 weeks gestational age. Method of measurement: Assessment of oxygen dependence by pulse oximetry.;Air leak syndroms (alveolar rupture due to severe dilation and air entrances to the pleural space). Timepoint: The length of time the patient is treated with one of two methods of nasal continuous positive air way pressure or nasal Duo positive air way pressure . Method of measurement: chest x ray.;Duration of hospitalization. Timepoint: From hospitalization until discharge. Method of measurement: Based on patient records.;The occurrence of death. Timepoint: During treatment with either of the two methods studied. Method of measurement: Clinical evaluation of the absence of vital signs.;Apnea (Respiratory interruption that last more than 20 seconds or less than 20 seconds but with cyanosis and bradycardia less than 100 beats per minute). Timepoint: During treatment with either of the two methods studied. Method of measurement: Pulse oximetry.;The number of surfactants used(A type of lipoprotein that is present in the inner wall of the alveolus .this drug used for respiratory distress syndrome) . Timepoint: First 48 hours after intervention. Method of measurement: Pulse oximetry and need to oxygen fraction>40% and positive end expirat

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMina Agahin

Ahvaz University of Medical Sciences

agahin.m@ajums.ac.ir+98 61 3222 2043

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 15, 2026