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IRCT20200714048101N2 IRCT 2026-06-29 Esfahan University of Medical Sciences the effect of pasteurization of mothers own milk contaminated with cytomegalovirus on clinical and laboratory outcomes of very premature infants Investigation the effect of pasteurization of mothers own milk contaminated with cytomegalovirus on clinical and laboratory outcomes of very premature infants admitted to selected hospitals of Isfahan University of Medical Sciences in 2026 2026-07-11 anticipated 130 Recruiting https://irct.ir/trial/91205 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Infants who meet the study eligibility criteria and whose medical records indicate breastfeeding, based on the attending physician's recommendation and parental consent, will first be enrolled in the study using a convenience sampling method from the selected hospitals. They will then be randomly allocated to either the intervention or control group using the permuted block randomization method. The randomization sequence will be generated using the Blockrand package in the R software, Blinding description: Blinding is possible and can be implemented spontaneously for the neonates, but not for the treatment team due to ethical considerations. Therefore, single-sided blinding (blinding of the outcome assessor and statistical analyst to group allocation) is considered. N/A cytomegalovirus. Intervention group: Infants receiving pasteurized MOM milk. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Zeinab Hemati
Hezarjerib St, Isfahan University of Medical Sciences Isfahan, Iran
Esfahan Iran (Islamic Republic of) 81746-73461 009837927505 z_hemate@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Zeinab Hemati
Hezarjerib St, Isfahan University of Medical Sciences Isfahan, Iran
Esfahan Iran (Islamic Republic of) 81746-73461 009837927507 z_hemate@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) *Preterm infants ≤ 28 weeks of gestation based on the first day of the last menstrual period. *Singleton or multiple pregnancies. *Vaginal or cesarean delivery. *No life-threatening congenital anomalies (based on evidence in the newborn's file: gastrointestinal, cardiac, neurological, etc.). *No chromosomal abnormalities (based on the newborn's file). *No asphyxia (based on the neonatologist diagnosis and the newborn's file).* Based on the volumes recorded in the intensive care unit sheets, infants in two groups who received at least 60% of their nutrition with pasteurized mom milk or unpasteurized mom milk.* At least 4-6 weeks of infant nutrition according to the assigned group. *Infants who did not have a positive blood culture at the beginning of hospitalization (based on the file).* Infants whose PCR-CMV result was negative in the first week of life and before the start of enteral feeding. 7 days 35 days Both *Transfer of the infant to a different hospital from the study setting, *Emergence of unrelated acute illnesses requiring interruption of enteral feeding or change of treatment protocol, *Death of the infant, *Parent withdrawal from participation in the study Prevention Intervention group: Infants receiving pasteurized MOM milk CMV infection. Timepoint: Before starting breastfeeding and 4 weeks after. Method of measurement: Urine PCR CMV. Necrotizing enterocolitis, lung dysplasia, retinal damage, leukomalacia, jaundice, liver enzyme levels, counts (neutrophils, platelets, leukocytes), CRP, and length of stay. Timepoint: Until discharge time. Method of measurement: Data in the newborn's file. Esfahan University of Medical Sciences Approved 2026-06-27 Ethics committee of Esfahan University of Medical Sciences Hezarjerib St, Isfahan University of Medical Sciences Isfahan, Iran Esfahan Isfehan Iran (Islamic Republic of)