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IRCT201709019568N18 IRCT 2017-09-30 Maternal, Fetal & Neonatal Research Center, Tehran University of Medical Sciences Effects of Iron administration on Auditory Brainstem Evoked Response in neonates at Risk of Latent Iron Deficiency Study of the Effects of Perinatal Iron Deficiency and Its Treatment on Auditory Brainstem Evoked Response in Neonates at Risk of Latent Iron Deficiency in the Vali-e Asr Hospital Maternity Ward 2018-03-21 anticipated 80 Complete https://irct.ir/trial/10143 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention. N/A Condition 1: Neonatal hearing impairment. Condition 2: Iron deficiency anemia. infants with Feritin concentrations corresponding to aforementioned definition of Latent Iron Deficiency, will be administered with 1 mg/kg iron drops (ferrous sulfate) from the start of the third week after birth until the end of the infant’s first month of life. At the end of the first month, ABR will be performed again and compared with the initial ABR..
public Dr. Elaheh Amini
Vali e asr Hospital,Imam Khomeini Hospital complexex, Keshavarz blv,14914, Tehran, Iran
Tehhran Iran (Islamic Republic of) +98 21 6659 1316 mfnhrc@yahoo.com Maternal Fetal and Neonatal Research Center scientific Dr Elaheh Amini
Vali e asr Hospital,Imam Khomeini Hospital complexex, Keshavarz blv,14914, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 6659 1316 mfnhrc@yahoo.com Maternal Fetal and Neonatal Research Center Iran (Islamic Republic of) Inclusion criteria: Neonates with gestational ages>35 weeks and weight over 2,500 grshowing at least one of the risk factors for in utero Latent Iron Deficiency including maternal diabetes, maternal gestational hypertension, intrauterine growth restriction, and Serum Feritin levels between 11-75 ng/mL. Exclusion criteria: Neonates with craniofacial anomalies, chromosome abnormalities, hemolytic diseases, history of infectious disease in the third trimester, clinical evidence of chorioamnionitis, 5-minute Apgar scores<5, evidence of TORCH infections, clinical or laboratory diagnosed sepsis, history of hospitalization in the NICU due to any medical issue. 14 days 30 days Both H90.5 D-50 Sensorineural hearing loss, unspecified anaemia Treatment - Drugs infants with Feritin concentrations corresponding to aforementioned definition of Latent Iron Deficiency, will be administered with 1 mg/kg iron drops (ferrous sulfate) from the start of the third week after birth until the end of the infant’s first month of life. At the end of the first month, ABR will be performed again and compared with the initial ABR. Neonatal hearing assessment. Timepoint: at birth and one month later. Method of measurement: ABR test. Maternal, Fetal & Neonatal Research Center, Tehran University of Medical Sciences Approved 2017-05-22 Ethics committee of Tehran University of Medical Sciences Ethics committee of Tehran University of Medical Sciences,6 th floor of Tehran University of Medical Sciences,ghods St., Keshavarz blv,Tehran, Iran Tehran Iran (Islamic Republic of)