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The role of synbiotic in the prevention of necrotizing enterocolitis in preterm neonates.

The role of synbiotic in the prevention of necrotizing enterocolitis in preterm neonates.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180519039715N2
Enrollment
118
Registered
2019-10-06
Start date
2018-09-23
Completion date
Unknown
Last updated
2019-11-05

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

Conditions

Necrotizing enterocolitis. Necrotizing enterocolitis of newborn

Interventions

Intervention 1: Intervention group: 1/25 cc/kg/day oral synbiotic (Made by bio-fermentation Co. in IRI, 1/25 cc synbiotic combination consisting of probiotic compounds contains Lactobacillus reuteri 4

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Admission to the Neonatal Intensive Care Unit (NICU) at birth Gestational age less than 34 weeks (early preterm) Elapse of maximum 28 days after birth birth weight 1000 to 1500 gr Lack of affliction with gastrointestinal obstruction, amphalocele, gastroschis, congenital heart disease, clinical or proven sepsis, grade 2 and 3 asphyxia No history of immunodeficiency among relatives No maternal drug addiction Avoidance of breast-feeding to feed neonate Avoidance of synbiotic supplementation consumption by the infant mother

Exclusion criteria

Exclusion criteria: Gestational age over 34 weeks Elapse of over 28 days since the birth of infant Birth weight less than 1000 (due to high mortality rates) and more than 1500 gr Neonate’s affliction with gastrointestinal obstruction, amphalocele, gastroschis, congenital heart diseases, clinical or proven sepsis, grade 2 and grade 3 asphyxia History of immunodeficiency among relatives Neonate with addicted mother Babies fed with powdered milk Oral administration of synbiotic supplement by neonate’s mother

Design outcomes

Primary

MeasureTime frame
Duration to reach full oral nutrition (150 cc kg/day). Timepoint: Measuring the time from birth to reach the age of full oral nutrition (150 cc/kg/day). Method of measurement: Asking parents.;Breast feeding tolerance. Timepoint: Measuring the amount of breast milk consumed per day and then daily until discharge. Method of measurement: Asking parents.;Necrotizing enterocolitis. Timepoint: Measurement from birth to discharge and daily. Method of measurement: Stage 1 (suspicion to enterocolitis): The symptoms include apnea, lethargy, bloody stool, abdominal distension, temperature instability, the residue in the stomach, lack of radiologic evidence. Stage 2 (proven enterocolitis): Symptoms of stage I + thrombocytopenia ± mild metabolic acidosis, abdominal tenderness, and presence of pneumatosis or gas in the portal vein. Stage 3 (advanced enterocolitis): Symptoms of stage 2 + hypotension, bradycardia, severe apnea, metabolic and respiratory acidosis, diffuse intravascular coagulation, clear abdominal tenderness, neutropenia, pneumoperitonitis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Shahidolahi

Kermanshah University of Medical Sciences

d.p_2011@yahoo.com+98 83 3826 4513

Outcome results

None listed

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