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Evaluation of the effect of probiotics on late-onset sepsis in very preterm newborns

Evaluation of the effect of probiotics on late-onset sepsis in very preterm newborns

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171218037936N1
Enrollment
84
Registered
2018-03-05
Start date
2017-02-19
Completion date
Unknown
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

late-onset sepsis in very preterm infants. Bacterial sepsis of newborn, unspecified

Interventions

Intervention 1: Intervention group: 42 preterm infants with a gestational age of less than 32 weeks and a weight of between 1,000-1,500 g and matched with clinical inclusion criteria for the study ra

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to No maximum

Inclusion criteria

Inclusion criteria: Preterm infants weighting 1000-1500 g and less than 32 weeks’ gestational age at birth Enrolled within 48 hours of birth

Exclusion criteria

Exclusion criteria: Major congenital anomalies(Esophageal atresia,Omphalocele,Imperforate anus) Major congenital heart malformations Genetic anomalies(e.g Trisomy 21 or other trisomies) Considered likely to die within 72 hours of birth Death before minimal entral feeding(10-20cc/kg/day) Parents from whom informed consent cannot be obtained Sepsis in admission(CRP>10mg/dl in 1st day of admission) Asphyxia (grade II, III) Maternal chorioamnionitis

Design outcomes

Primary

MeasureTime frame
Late-onset sepsis. Timepoint: Baseline(admission), weekly and when clinical sepsis suspected. Method of measurement: Measurement of C-Reactive Protein and clinical clinical evaluation.

Secondary

MeasureTime frame
Necrotizing enterocolitis. Timepoint: On admission, every week, when symptoms of Necrotizing enterocolitis are diagnosed. Method of measurement: Clinical evaluation based on Bell's Criteria.;Duration of primary hospitalization. Timepoint: Time of discharge. Method of measurement: Count the number of hospitalization days.;The number of days the infant takes to complete entral feeding(120mL/kg per day). Timepoint: During the study period. Method of measurement: number of days until an infant to eat 120mL / kg per day of milk.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSiamack Karimi Heydarabad

Oroumia University of Medical Sciences

siamack.karimi@gmail.com+98 44 3223 7078

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026