Respiratory distress syndrome of newborn. Hyaline membrane disease
Conditions
Interventions
Neonates in group 2, one minute before intubation recieve 1 microgram per kilogram slow intravenous Remifentanil (manufactured by Mylan company) infusion in 2 minutes.
Intervention 1: Neonates in group1, one minute before intubation recieve 2 microgram per kilogram slow intravenous Fentanyl (manufactured by Abureyhan company)infusion
Treatment - Drugs
Neonates in group1, one minute before intubation recieve 2 microgram per kilogram slow intravenous Fentanyl (manufactured by Abureyhan company)infusion in 2 minutes.
Sponsors
Vice Chancellor for Research of Tabriz University of of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Days to 3 Days
Inclusion criteria
Inclusion criteria: Inclusion criteria:Preterm newborns with gestational age between 28 to 34 weeks and 6 days from last menstrual period of mother who was born in Alzahra teaching hospital of Tabriz; clinical criteria of respiratory distress (consists of: tachypnea, grunting, inter coastal retraction and increased oxygen requirement) and radio graphic findings of Respiratory Distress Syndrome; need for surfactant treatment by INSURE (Intubate, Surfactant, Extubate) procedure. Exclusion criteria: other causes of respiratory distress in newborns; second or third degree AV heart block; use of fentanyl during 4 hours from delivery; severe asphyxia (APGAR score under 5 at 5th minutes after delivery ); impaired consciousness level; major congenital anomalies; difficult intubation due to facial anomalies; more than three attempts for intubation.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Score. Timepoint: During endotracheal intubation. Method of measurement: PIPP-R pain assessment tool (Premature Infant Pain Profile-Revised). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time need for succesfull intubation. Timepoint: From starting time of intubation prosedures. Method of measurement: Seconds.;Chang in heart rate, pulesxymetery amd blood pressure. Timepoint: Before, during and after endotracheal intubation. Method of measurement: Manitoring by automatic monitor and record of blood pressure by appropriate cuff.;Number attempts for a successful intubation. Timepoint: During endotracheal intubaion. Method of measurement: Observation.;Apnea ( stoping of respiration more than 20 seconds ). Timepoint: During intubation prosedures. Method of measurement: Observation and recording.;Sever hypoxia ( O2 saturaion<70%). Timepoint: During and after endotracheal intubation. Method of measurement: Manitoring by automatic monitor.;Chest rigidity. Timepoint: During and after endotracheal Intubation. Method of measurement: Observation and recording.;Need for use of Naloxan. Timepoint: After endotracheal intubation. Method of measurement: Observation and recording.;Intraventricular hemorrage grade 2 and more. Timepoint: Day 3. Method of measurement: Ultrasonography with portable Sonoraphy device. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammadbagher Hosseini MD
Tabriz University of Medical Sciences
Outcome results
None listed