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IRCT201112078314N1 IRCT 2013-01-14 Children Health Research Center Comparing surfactant administration without intubation with conventional method Comparing outcome of surfactant administration via tracheal catheterization during spontaneous breathing (tec-care) with tracheal intubation accompany with positive pressure ventilation (INSURE) in premature neonates with respiratory distress syndrome. 2012-08-22 anticipated 180 Complete https://irct.ir/trial/8755 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Respiratory distress syndrome. Intervention 1: Clinical guideline for administering surfactant viaTEC-CARE: 1. NCPAP pressure should be increased as much as 8 to 10 cmh2o 2. In order to decrease secretions of the neonate we administer atropin 5ug/kg before intubation 3.The neonate is intubated by a 5f feeding tube.The tip of the catheter is guided through 1 to 2 cm below the vocal cords. 4. After placement the Feeding tube laryngoscope is removed from the mouth and surfactant is administrated slowly. Surfactant is injected slowly over 1 to 3 minutes. 5. If you require Fio2 over 40% readministration of Surfactants is possible. a. During administration, the baby may be suffering from obstructive apnea then slowly stimulates the baby and increase the percentage of oxygen b. Surfactant reflux into the infant's mouth will normal, it is recommended that if there is no acute respiratory failure suction secretions from baby's mouth should be avoided. c.If sever respiratory failure accur and there is no response to stimulation and increased spo2 then ventilate the neonate with nasal prong or nasal mask or bag and mask and after recovery administer surfactant d. After Surfactant administration return NCPAP pressure to 6cmh20. Intervention 2: Clinical Guide line for administering surfactant via INSURE: 1.Neonates are removed from NCPAP. 2. Before intubation 2μg / kg Fentanylwas injected for Sedation 3. Neonate is intubated with endotracheal tube appropriate to weight and gestational age then ensure for its proper place. 4. surfactant is administered by a 5f feeding tube 5.After intubation the neonate is ventilated for 1 min via bag and mask or T-Piece or ventilator until spo2 is more than 85% 6. Naloxone is administered 0.1 mg / kg. 7. Baby is Extubated 8. NCPAP is once again placed. 9. Assisted ventilation continues by NCPAP.
public Dr.Kayvan Mirnia
Alzahra hospital,Artesh street,Tabriz,East Azarbaijan,Iran
Tabriz Iran (Islamic Republic of) +98 41 1553 7493 kmirnia@yahoo.com Alzahra hospital scientific Dr.Mohammad Heidarzadeh
Health ministry,Hafez-Jomhori cross section,Tehran,Iran
Tehran Iran (Islamic Republic of) 5163957686 +98 21 6670 0145 heidarzadeh@health.gov.ir Neonatal health office Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Neonates with gestational age of 27-36 weeks with respiratory distress syndrome that required surfactant administration; Delivered in Multi center hospitals of (Alzahra and 29 bahman from Tabriz; Ommolbanin from Mashhad and Shahid Beheshti from Esfehan); Were resuscitated according to resuscitation guide line 2006 .Exclusion criteria: Neonates with congenital disease ;Apgar score of less than 6 within 5 minutes . 27 years 36 years Both P22 Respiratory distress syndrome of newborn Treatment - Devices Treatment - Devices Clinical guideline for administering surfactant viaTEC-CARE: 1. NCPAP pressure should be increased as much as 8 to 10 cmh2o 2. In order to decrease secretions of the neonate we administer atropin 5ug/kg before intubation 3.The neonate is intubated by a 5f feeding tube.The tip of the catheter is guided through 1 to 2 cm below the vocal cords. 4. After placement the Feeding tube laryngoscope is removed from the mouth and surfactant is administrated slowly. Surfactant is injected slowly over 1 to 3 minutes. 5. If you require Fio2 over 40% readministration of Surfactants is possible. a. During administration, the baby may be suffering from obstructive apnea then slowly stimulates the baby and increase the percentage of oxygen b. Surfactant reflux into the infant's mouth will normal, it is recommended that if there is no acute respiratory failure suction secretions from baby's mouth should be avoided. c.If sever respiratory failure accur and there is no response to stimulation and increased spo2 then ventilate the neonate with nasal prong or nasal mask or bag and mask and after recovery administer surfactant d. After Surfactant administration return NCPAP pressure to 6cmh20 Clinical Guide line for administering surfactant via INSURE: 1.Neonates are removed from NCPAP. 2. Before intubation 2μg / kg Fentanylwas injected for Sedation 3. Neonate is intubated with endotracheal tube appropriate to weight and gestational age then ensure for its proper place. 4. surfactant is administered by a 5f feeding tube 5.After intubation the neonate is ventilated for 1 min via bag and mask or T-Piece or ventilator until spo2 is more than 85% 6. Naloxone is administered 0.1 mg / kg. 7. Baby is Extubated 8. NCPAP is once again placed. 9. Assisted ventilation continues by NCPAP Continuous positive airway pressure failure. Timepoint: Half-Hour after intervention. Method of measurement: Increasing respiratory distress syndrome score. Duration of hospitalization. Timepoint: Time of discharge from hospital. Method of measurement: Extracted from the file. Intraventriculal hemorrhage. Timepoint: 7th day after birth. Method of measurement: Cranial ultrasonography by a radiologist. Chronic lung disease. Timepoint: 36th week of gestational age. Method of measurement: Observation of hospital file for oxygen requirment at 36th weeks of postconceptional age. No No Children Health Research Center Approved 2012-04-16 Ethics committee of Tabriz University of Medical Sciences Medical Faculty, Tabriz University of Medical Sciences,Golgasht street,Tabriz,East Azarbaijan,Iran Tabriz Iran (Islamic Republic of)