Status:

COMPLETED

The Efficacy of Symbiotic on Cytokines

Lead Sponsor:

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Conditions:

Necrotising Enterocolitis

Eligibility:

All Genders

1-2 years

Phase:

PHASE3

Brief Summary

The aim of this prospective double blinded randomised study is to investigate the efficacy of symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L. plantarum, Bifidobacterium lact...

Detailed Description

Inclusion criteria: 1. Neonates who born 26- 32 gestational week and 750-1500 gram birth weights 2. Neonates who tolerated minimal enteral feeding within postnatal first week Exclusion criteria: 1....

Eligibility Criteria

Inclusion

  • Neonates born 26- 32 gestational weeks and 750-1500 gram birth weights
  • Neonates who tolerated minimal enteral feeding during first week of life

Exclusion

  • PROM\> 24 hour and/or chorioamnionitis
  • Mechanical ventilation supply more than 7 days
  • Culture proven sepsis
  • Major congenital anomaly
  • Neonates undergoing surgery

Key Trial Info

Start Date :

July 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2013

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT01899677

Start Date

July 1 2013

End Date

September 1 2013

Last Update

August 8 2014

Active Locations (1)

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Zeynep Kamil Maternity and Child Health Hospital

Istanbul, Umraniye, Turkey (Türkiye), 34668