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IRCT2017102637023N1 IRCT 2017-11-14 Urmia University of Mecidal Sciences Effect of parenteral caffeine citrate for prevention of apnea in very preterm neonates in NICU ward The survey of the effect of parenteral caffeine citrate for prevention of apnea in very preterm neonates in NICU part of Shahid-Motahary hospital for one year 2017-01-20 anticipated 100 Complete https://irct.ir/trial/27506 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Apnoea. Intervention 1: Control received no caffeine. Intervention 2: Infants of intervention group on the second day of birth (24-48 h) intravenous caffeine citrate with a dose of 20mg/kg and then the maintenance dose 24 hours after the first injection with a dose of 5mg/kg daily injected.
public Dr Zahra Fakoor
Shahid-Motaharri Hospotal
Urmia Iran (Islamic Republic of) +98 44 3224 4830 drfakoor@umsu.ac.ir Urmia University of Medical Sciences scientific Dr Zahra Fakoor
Shahid-Motaharri Hospital
Urmia Iran (Islamic Republic of) +98 44 3224 4830 drfakoor@umsu.ac.ir Urmia University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria for entering were the premature newborns weighing less than 1500 grams at least 24 hours of age and having self-contained breathing in the first 24 hours of life; and exclusion criteria were maternal major anomalies, the incidence of apnea in the first 24 hours of life and the need for mechanical ventilation in 24 The first hour of birth, cyanotic heart disease, small age for gestational age (SGA, IUGR), intrauterine growth retardation, as well as clinical evidence for sepsis during the first 7 days of birth and IVH grade 3 or 4 during the first week of life. 1 day 8 months Both P28.3 Primary sleep apnoea of newborn Placebo Treatment - Drugs Control received no caffeine. Infants of intervention group on the second day of birth (24-48 h) intravenous caffeine citrate with a dose of 20mg/kg and then the maintenance dose 24 hours after the first injection with a dose of 5mg/kg daily injected. Apnoea. Timepoint: From beginning to end of intervention. Method of measurement: The number of cases of apnea reported by the nurse. Bradicardia. Timepoint: From beginning to end of intervention. Method of measurement: The number of cases of bradicardia reported by the nurse. Cyanosis. Timepoint: From beginning to end of intervention. Method of measurement: The number of cases of cyanosis reported by the nurse. Duration of oxygen demand. Timepoint: From beginning to end of intervention. Method of measurement: Duration of oxygen demand reported by the nurse. Duration of NCPAP demand. Timepoint: From beginning to end of intervention. Method of measurement: Duration of NCPAP demand reported by the nurse. Duration of mechanical ventilation demand. Timepoint: From beginning to end of intervention. Method of measurement: Duration of mechanical ventilation demand reported by the nurse. Hospitalization. Timepoint: From beginning to end of intervention. Method of measurement: Patients' Records. Urmia University of Mecidal Sciences Approved 2016-12-09 Urmia University of Medical Sciences Urjans Street - Head of Urmia University of Medical Sciences Urmia Iran (Islamic Republic of)