Respiratory Distress Syndrome of Newborn. Respiratory distress syndrome of newborn
Conditions
Interventions
Treatment - Devices
Sponsors
Pediatric health research center of Tabriz University of Medical Sciences
ParsEltiam_Kala/medicalequipment companies
Eligibility
Sex/Gender
All
Age
1 Years to 28 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: infants who were born in Alzahra medical center of Tabriz, gestational age between 28-37 weeks, diagnosed as Respiratory Distress syndrome of newborn, eligible for CPAP (clinical distress, PCO2 < 65 mm Hg, oxygen requirement greater than 30%, radiological finding of poor lung expansion) Exclusion criteria: presence of major congenital malformations such as cleft palate, congenital heart disease, neuromuscular disease, severe birth asphyxia (Apgar score at five minutes of less than 4 and serum bicarbonate < 12 mmol/l in the first hour), overwhelming infections, severe respiratory failure such as Apnea
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total duration of need for CPAP. Timepoint: From start untill discontinuation of CPAP acording to weaning program. Method of measurement: Hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of need for surfactant therapy. Timepoint: During hospital stay. Method of measurement: need for surfactant therapy according to protocol after start of NCPAP.;CPAP failure. Timepoint: During hospital stay. Method of measurement: Apnea and bradycardia need ventilation or need for intubation and Paco2 more than 55 mmhg instead of receiving positive airway pressure level more than 6 mmhg and FIO2 more than 60 percent.;Incidence of air leak syndroms. Timepoint: During hospital stay. Method of measurement: each form of air leak syndroms after start of CPAP.;Incidence of intraventricular hemorrage (grade 2 and more). Timepoint: 3th and 7th days after birth. Method of measurement: Ultrasonografic finding of intraventricular hemorrage.;Total duration of need for Oxygen therapy. Timepoint: During hospital stay. Method of measurement: days need for oxygen during CPAP or therafter.;Incidence of Pulmonary hemrrage. Timepoint: During hospital stay. Method of measurement: acute onset of severe endotracheal bleeding with an acute drop in hematocrit and the development of multilobar infiltrates on chest radiograph during period of CPAP therapy.;Extrapulmonary complications such as sepsis (positive blood culture) Necrotizing entrocolitis (stage 2 and more) necrosis of nocs septum. Timepoint: During hospital stay. Method of measurement: extrapulmonary complication such as sepsis (positive blood culture) Necrotizing entrocolitis (stage 2 and more) necrosis of nose septum after start of NCPAP.;Outcome of neonates (discharge, death, transfer). Timepoint: During hospital stay. Method of measurement: checklist.;Incidence of Broncopulmonary Displasia. Timepoint: need for oxygen or ventilatory support after 28 day of birth for infants with GA>32 weeks and more than 36 week of postconseptional age for infants with GA32 weeks and more than 36 week of postconseptional age for infants with GA<32 weeks. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad bagher Hosseini
Alzahra teaching hospital of Tabriz
Outcome results
None listed