Prematurity and very low birth weight in neonates (preterm infants with birth weight less than 1500 grams).. Preterm [premature] newborn [other]
Conditions
Interventions
Intervention 1: Intervention group: Participants in this group will receive 5 drops per day of the probiotic Lactobacillus reuteri (commercially available as Prokid, manufactured by Gostaresh Milad Ph
Sponsors
Oroumia University of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 30 Days
Inclusion criteria
Inclusion criteria: Very low birth weight (VLBW) premature infants (birth weight < 1500 grams). Admission to the Neonatal Intensive Care Unit (NICU) of Shahid Motahari Hospital, Urmia. Admission during the study period in the year 1404 (2025-2026). Parental or legal guardian informed consent obtained for participation.
Exclusion criteria
Exclusion criteria: Premature infants with a gestational age of less than 28 weeks at birth. Deterioration of the infant's clinical condition after enrollment in the study. Parental withdrawal of consent for continued participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of necrotizing enterocolitis (NEC), defined as inflammation and bacterial invasion of the intestinal wall leading to cellular damage and necrosis. Timepoint: The outcome will be assessed daily from the start of the intervention (probiotic/placebo administration) until discharge from the neonatal intensive care unit (NICU), death, or reaching 40 weeks of postmenstrual age. Method of measurement: Diagnosis will be based on the modified Bell's staging criteria, incorporating clinical signs (abdominal distension, gastric residuals, bloody stools), radiographic findings (pneumatosis intestinalis, portal venous gas, pneumoperitoneum on abdominal X-ray), and/or pathological confirmation during surgery or autopsy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of Ventilator-Associated Pneumonia (VAP), defined as a pneumonia (lung infection) that develops in a patient who has been on mechanical ventilation for more than 48 hours. Timepoint: The outcome will be assessed daily from the start of the intervention until successful extubation, discharge from the neonatal intensive care unit (NICU), death, or reaching 40 weeks of postmenstrual age. Method of measurement: Diagnosis will be made based on the Centers for Disease Control and Prevention criteria for Ventilator-Associated Pneumonia, which require a combination of new or worsening infiltrates on chest radiograph plus clinical signs (e.g., fever, increased secretions, worsening gas exchange) and microbiological findings (positive culture from endotracheal aspirate or bronchoalveolar lavage). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKamran Dehghan
Oroumia University of Medical Sciences
Outcome results
None listed