Respiratory Distress Syndrome in the newborn. Respiratory Distress syndrome
Conditions
Interventions
Intervention 1: In control group nasal CPAP of 6 cm H2O is administered for the patients and the infant remains on NCPAP.Any patient who needs mechanical ventilation (according to criteria below) is
Treatment - Devices
Treatment - Drugs
In control group nasal CPAP of 6 cm H2O is administered for the patients and the infant remains on NCPAP.Any patient who needs mechanical ventilation (according to criteria below) is intubated and pl
In the treatment group the patient is placed on nCPAP and then temporarily intubated. A natural surfactant (Survanta , Abbot Laboratories, Abbot Park, IL) 100 mg/Kg is administered intratrachealy and
Sponsors
Mazandaran University of Medical Siences
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: gestational age less than 35 weeks; age less or equal to 12 hours after birth; the presence of symptoms of respiratory distress syndrom (RDS); symptoms begun in the first 6 hours after birth; radiologic signs for RDS in chest radiography. The exclusion criteria: 5 minutes Apgar score less than 6; intubation before reaching Bu-Ali Hospital, presence of major anomalies, PROM> 12 hours, admission to Bu-Ali Hospital after 12 hours of age, signs and symptoms of chorioamnionitis in mother, beginning of respiratory distress after 6 hours of birth, need for mechanical ventilation (on the basis of our defined criteria) at the time the patient reaches to Bu-Ali Hospital.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need for mechanical ventilation. Timepoint: daily within the first week of life. Method of measurement: physical exam for significant respiratory distress and/or the presence of persistent or recurrent apnea and check of ABG for hypoxia or respiratory acidosis . | — |
Secondary
| Measure | Time frame |
|---|---|
| Neonatal mortality. Timepoint: during hospitalization. Method of measurement: hospital documents.;Duration of hospital stay. Timepoint: during of hospitalization. Method of measurement: hospital documents.;The incidence of pneumothorax. Timepoint: till 72 hours after birth. Method of measurement: CXR.;Pulmonary hemorrhage. Timepoint: till 72 hours after birth. Method of measurement: cilinical diagnosis and CXR.;Number of rescue doses of surfactant. Timepoint: till 48 hours after birth. Method of measurement: hospital documents.;The incidence of chronic lung disease (CLD). Timepoint: till 36 weeks’ postnatal age. Method of measurement: oxygen requirement at 36 weeks’ postnatal age.;Intraventricular hemorrhage (IVH). Timepoint: 7-14 days after birth. Method of measurement: brain sonography.;Periventricular leukomalacia (PVL). Timepoint: between 36 and 40 weeks; postnatal age. Method of measurement: brain sonography.;The incidence of retinopathy of prematurity. Timepoint: 4 weeks' of age and then every week till vascularization is completed. Method of measurement: eye exam.;Duration of mechanical ventilation. Timepoint: during hospital stay. Method of measurement: hospital documents.;Duration of need for oxygen. Timepoint: during hospital stay. Method of measurement: hospital documents. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Nakhshab
Mazandaran University of Medical Siences
Outcome results
None listed