Effect of probiotics on the incidence of necrotizing enterocolitis in preterm

Phase 2

• Conditions: ecrotizing enterocolitisPreterm neonatesNeonatal sepsis; Probiotics; Necrotizing enterocolitis; Preterm; Neonatal sepsis

• Registration Number: TCTR20200101001
• Lead Sponsor: Faculty of Medicine Siriraj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study Completion: 2023-07-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

- Preterm neonates with postmenstrual age less than or equal 33 wk and birth weight less than or equal 1500 g
- Admitted to NICU or intermediate care ward
- Able to tolerate feeding at least 1 ml/feed every 3 hours for 8 feeds
- Has not received antibiotic for at least 24 hr before enrollment
- Parental consent
- Physician agrees for the patient to enroll

Exclusion Criteria

- Known or suspected immunodeficiency
- Inborn error of metabolism
- Congenital heart disease except PDA, ASD and VSD
- Congenital anomaly of GI tract
- Previous NEC stage 2 or 3
- Patients having active infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EC stage 2 or above From enrollment to hospital discharge Clinical diagnosis, abdominal Xray

Secondary Outcome Measures

Name	Time	Method
Incidence of neonatal sepsis Within 30 days and 60 days after enrollment or until hospital discharge Clinical diagnosis and blood culture,Hospital mortality rate - -,Time to full enteral feeding - Number of days from enrollment to full enteral feeding (at least 120 ml/kg/day),Incidence of infection due to probiotic strain From enrollment to hospital discharge Clinical diagnosis and culture results