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The effect of probiotics in prevention of necrotizing enterocolitis

The effect of oral probiotics in prevention of necrotizing enterocolitis in premature neonates.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014022716574N3
Enrollment
50
Registered
2014-05-24
Start date
2013-07-23
Completion date
Unknown
Last updated
2018-02-22

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 fetus and newborn

Interventions

Placebo
Intervention 1: Intervention group: When volume of feeding reaches to 5cc/kg/day, 1 drop/kg of oral probiotics drop (Pedilact, Sepehr Pharmaceutics, Iran) diluted with normal saline to 0.5cc will be a
Prevention
Intervention group: When volume of feeding reaches to 5cc/kg/day, 1 drop/kg of oral probiotics drop (Pedilact, Sepehr Pharmaceutics, Iran) diluted with normal saline to 0.5cc will be administered each
Control group: 0.5 cc of normal saline (Samen Pharmaceutics, Iran) will be administered each 12 hours when volume feeding reaches to 5 cc/kg/day.

Sponsors

Vice Chancellor for research, Shahid Sadoughi University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 3 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: Neonates with gestational age <36 weeks; Birth weight 1000-2500 grams and admitted in NICU ward of the Shahid Sadughi hospital; Yazd Exclusion criteria: Neonates with obstruction of gasterointestinal; Congenital heart disease; Omphalocele; Gasterochesia; Asphyxia (grade II,III)and Addiction of mother.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Necrotizing enterocolitis. Timepoint: During intervention. Method of measurement: Bell staging criteria.

Secondary

MeasureTime frame
When full enteral feeding is reached. Timepoint: During intervention. Method of measurement: Per day.;Weight of neonate at the time of discharged. Timepoint: When the neonate is discharged. Method of measurement: With scale(seca).;During hospitalization. Timepoint: When the neonate is discharged. Method of measurement: Per day.;Mortality. Timepoint: During intervention. Method of measurement: Per person.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFateme Naghibifard

Shahid Sadoughi Hospital

Naghibifard_128@yahoo.com+98 35 1822 4000

Outcome results

None listed

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