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IRCT20201213049705N1 IRCT 2021-02-16 Tehran University of Medical Sciences the Efficacy and Safety of Intra-Tracheal Administration of Beraksurf in Comparison with Survanta and Curosurf in Neonates with RDS Evaluation of the Efficacy and Safety of Intra-Tracheal Administration of Beraksurf in Comparison with Survanta and Curosurf in Neonates with Respiratory Distress Syndrome: A Three-Arm Randomized Clinical Trial 2019-10-07 anticipated 90 Complete https://irct.ir/trial/53525 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was performed between the three groups using blocks of double triple allele random numbers (size 6); group A: Beraksurf, group B: Survanta, group C: Curosurf, Blinding description: Participants (infants) were unaware of the type of drug used, the physician prescribing the drug and observing the symptoms and side effects was aware of the type of intervention because that the form and nature of the drugs were different and it was not possible to unify them. The researchers who collected, reviewed, and analyzed the data were blinded to the type of interventions. 3 Respiratory distress syndrome. Intervention 1: Intervention group: Beraksurf group. In this group, Beraksurf ampoules made by Tekzima Daru Company (Iran) in a dose of 4cc/kg will be injected intratracheally. Injections can be injected every 6 to 12 hours and up to 4 doses if needed until the patient's FIO2 reaches 30%. Intervention 2: Intervention group: Survanta group. In this group, Survanta ampoule made by Chiesi company (Italy) with an initial dose of 2.5cc/kg will be injected intrateracheally. If needed, repeated every 12 hours and a maximum of two doses of 1.25cc/kg can be injected until the patient's FIO2 reaches 30%. Intervention 3: Intervention group: Curosurf group. In this group, Kurosorf ampoules made by Abbot Company (USA) with an initial dose of 4cc / kg will be injected intrachip. If needed, repeat every 6 to 12 hours and up to 4 doses of 4cc / kg can be injected until the patient's FIO2 reaches 30%. Yes - There is a plan to make this available What will be shared: Data related to patients' demographic information, primary and secondary outcomes, other than those mentioned in the article resulting from the project, will be provided to them if requested by the editor or reviewers of the journal in which the article was submitted. The data will be published if the journal's instructions make it mandatory to provide all additional data as a supplementary file. When: If it is needed as a supplementary file, at the same time as submitting the article and at the request of the journal for about two weeks To whom: The editor and editors of the magazine will be able to access it at the request and in case of compulsion as a supplementary file, everyone will be able to access. Conditions: In order to further investigate the journal team and answer any questions they may have, and if required, to provide it as a supplementary file, no data restrictions will be provided. Where to obtain: Afsaneh Alimohammadi Address: 2nd floor, Vali-Asr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran, Iran. E-mail: afsanehalimohamadi788693@gmail.com Tel.: +98 2161192052 How to obtain: The requesting persons while introducing themselves must explain why they are requesting access to the data in an e-mail. A signed form of data rights and copyright laws must be submitted. after reviewing the information request in consultation with other authors, the data will be available within two to three weeks. Comments:
public Dr. Afsaneh Alimohammadi
Kashavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733134 +98 21 6119 2052 afsanehalimohamadi788693@gmail.com Tehran University of Medical Sciences scientific Dr. Afsaneh Alimohammadi
Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733134 +98 21 6119 2052 afsanehalimohamadi788693@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Neonates with RDS Premature infants with ≥25 to 34 weeks of gestation Included during the first 8 hours of birth required more than 30% FIO2 1 day 2 months Both severe asphyxia at birth with a 5th minute Apgar score of less than 6 severe congenital anomalies such as heart disease and life-threatening abnormalities Rupture of membranes for longer than 2-weeks Multiple anomalies septicemia, respiratory failure for reasons other than RDS J00–J99 Diseases of the respiratory system Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Beraksurf group. In this group, Beraksurf ampoules made by Tekzima Daru Company (Iran) in a dose of 4cc/kg will be injected intratracheally. Injections can be injected every 6 to 12 hours and up to 4 doses if needed until the patient's FIO2 reaches 30%. Intervention group: Survanta group. In this group, Survanta ampoule made by Chiesi company (Italy) with an initial dose of 2.5cc/kg will be injected intrateracheally. If needed, repeated every 12 hours and a maximum of two doses of 1.25cc/kg can be injected until the patient's FIO2 reaches 30%. Intervention group: Curosurf group. In this group, Kurosorf ampoules made by Abbot Company (USA) with an initial dose of 4cc / kg will be injected intrachip. If needed, repeat every 6 to 12 hours and up to 4 doses of 4cc / kg can be injected until the patient's FIO2 reaches 30%. Percentage of infants with low oxygen index, which was considered to require more than 30% FIO2. Timepoint: monitoring the displayed amount on the ventilator's monitor every 4 hours for the first 72 hours and after that every 12 hours until the 28th day. Arterial blood gas (ABG) or venous blood gas (VBG) was taken every 4 to 6 hours in the first 24 hours and every 4 to 12 hours in the next 48 hours. Method of measurement: Ventilator device and taking venous and arterial blood and sending to emergency laboratory for ABG and VBG tests. Death. Timepoint: Every 2 to 4 hours for 28 days. Method of measurement: Checking the neonate's vital signs. Duration of the mechanical ventilation. Timepoint: every 4 hours. Method of measurement: Checking the oxygen index and oxygen saturation percentages of the ventilator and ABG and VBG tests. Sepsis. Timepoint: every 2 to 4 hours. Method of measurement: General malaise with tachypnea / hypotension / symptom instability / plus positive blood culture or CSF. Bronchopulmonary dysplasia (BPD). Timepoint: every 4 hours. Method of measurement: Oxygen dependence after 28 days by checking the status of respiratory indices. Tehran University of Medical Sciences Approved 2019-01-30 Ethics Committee of Tehran University of Medical Sciences Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)