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IRCT2016060128188N1 IRCT 2016-10-22 Vice Chancellor for research of Mazandaran University of Medical Sciences Preventive effect of droplets on infant's jaundice The investigating of the prophylactic effect of Manna of Cotoneaster in neonatal jaundice 2016-12-21 anticipated 444 Complete https://irct.ir/trial/22922 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Using blocking method, Randomization description: Using blocking method, Blinding description: To double-blind study, cotoneaster solution and placebo solution container similar appearance and the user, administer and appraiser of them do not know about it. Bilirubin drop and placebo drops (drug and placebo ) are provided by the laboratory of Sari Pharmacy Faculty. N/A Neonatal jaundice. Intervention 1: Intervention group:The amount of 1 g of cotoneaster per day is divided into 3 doses for 3 days. Intervention 2: Control group: The neonate will receive placebo. The number of placebo drops per day is similar to the number of cotoneaster drops. Yes - There is a plan to make this available What will be shared: All information will be published in an article. Details of the data are available at the request of the journal publisher and upon obtaining permission from the corresponding author. When: Data is available as an article as soon as the article is published with permission from the corresponding author. To whom: The data is provided as an article by the journal, and those who have access to the journal can use the data contained in the article, with the permission of the corresponding author. Conditions: The article's data is available in case of publication and is obtained by permission from the corresponding author. Where to obtain: The data is available to the journal and is accessible by obtaining permission from the corresponding author. How to obtain: Data is available from the journal after publication of the article. Comments:
public Dr. Azadbakht
Pharmacology Faculty of Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) 4847191971 +98 11 3354 3728 azadbakht110@gmail.com Mazandaran University of Medical Sciences scientific Mrs Dr.Farhadi
Sari Imam khomeini Hospital
Sari Iran (Islamic Republic of) 4847191971 +98 11 3336 1700 dr_royafarhadi@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Full-term baby (with gestational age 38-42 weeks) Birth weight 2.5-4 kg No postpartum complications Breastfeeding within the hour of birth Availability of parents for follow-up purposes PO tolerance by the infant (no nausea, vomiting or obstructive symptoms The absence of meconium contamination No need for CPR at birth No labor trauma 1 day 14 days Both Genetic and congenital abnormalities or intrauterine infections Jaundice within the first 24 hours of birth ABO or Rh incompatibility Presence of neonatal hemolytic process Neonates with bleeding and cephalohematoma Self-administration of Cotoneaster p59.9 neonatal jaundice Treatment - Drugs Treatment - Drugs Intervention group:The amount of 1 g of cotoneaster per day is divided into 3 doses for 3 days. Control group: The neonate will receive placebo. The number of placebo drops per day is similar to the number of cotoneaster drops Added at 2017-06-11: Baby serum total bilirubin. Timepoint: Added at 2017-06-11: Every 24 hours for 3 days. Method of measurement: Added at 2017-06-11: Using a bilirubin test device (if a bilirubin is high, a bilirubin serum test will be performed based on the weight and age curve). Require hospitalization and Length of hospitalization days. Timepoint: From discharge to 14 days after birth. Method of measurement: Follow up by phone from the baby's parents. Added at 2017-06-18: Evaluation of side effects in case of Cotoneaster. Timepoint: Added at 2017-06-18: Every 24 hours for 3 days. Method of measurement: Added at 2017-06-18: Observation and complete check list. Vice Chancellor for research of Mazandaran University of Medical Sciences Approved 2015-04-08 Ethics committee of Mazandaran University of Medical Sciences Mazandaran,Sari, Moalem square Sari Mazandaran Iran (Islamic Republic of)