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IRCT20210825052289N1 IRCT 2021-09-14 Ardabil University of Medical Sciences Evaluation of the effect of melatonin in the treatment of sepsis The effect of melatonin on the course of treatment and complications of sepsis in infants 2021-09-11 anticipated 50 Complete https://irct.ir/trial/58360 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: The aim of this study is , reduce hospitalization time and help improve neonatal sepsis treatment to prevent further complications, Randomization description: Patients will be enrolled randomly in to one of the groups based on inclusion criteria. Randomisation sequence will be processed by Microsoft Excel program via (RANDBETWEEN) command and numbers 0 and 1 will be allocated to each group to choose the group of the subject. 3 sepsis in neonates. Intervention 1: Intervention group: Patients of this group will receive Melatonin tablet from Normlife Company every 12 hours for 3 days. Intervention 2: Control group: Patients of this group will not receive Melatonin tablet. Yes - There is a plan to make this available What will be shared: All information is shareable When: Start the access period after printing the results To whom: Available to university researchers. Conditions: Can be used for similar research Where to obtain: by Email Drarminghahreman@gmail.com How to obtain: Have a letter of recommendation from the desired university. Comments:
public Armin Ghahremanzadeh
Bouali hospital, Moallem Aven., Ardabil Town
Ardabil Iran (Islamic Republic of) 5613643197 +98 45 3325 2251 Drarminghahreman@gmail.com Ardabil University of Medical Sciences scientific Armin Ghahremanzadeh
Bouali hospital, Moallem Ave., Ardabil Town
Ardabil Iran (Islamic Republic of) 5613643197 +98 45 3325 2251 Draminghahreman@gmail.com Ardabil University of Medical Sciences Iran (Islamic Republic of) Parental consent Infants under one month of age Diagnosis of sepsis according to clinical and laboratory criteria NPO patient(Non Pre Oral) absence of any underlying disease infants with gestational age above 37 weeks 1 day 28 days Both Parental dissatisfaction Death of the patient during melatonin administration Existence of congenital anomalies Existence of severe sepsis Presence of congenital heart disease PO intolerance and frequent vomiting P36.9 Bacterial sepsis of newborn, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Patients of this group will receive Melatonin tablet from Normlife Company every 12 hours for 3 days. Control group: Patients of this group will not receive Melatonin tablet. White blood cell. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample. C-Reactive Protein. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample. Interleukin-6. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample. Neonates general status. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Based on Attending's evaluation in 3 categories: Well, Ill and Toxic. Poorfeeding. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Based on Attending's evaluation. Outcome. Timepoint: Upon discharge. Method of measurement: Death or Living based on Attending's evaluation. Length of hospital stay. Timepoint: Upon discharge. Method of measurement: Based on date's submitted to patient profile. Ardabil University of Medical Sciences Approved 2021-08-09 Ethic committee of Ardabil University of Medical Sciences Moallem Ave., Ardabil Town Bouali hospital Ardabil Ardabil Iran (Islamic Republic of)