NCT01807858

The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Dr. Sami Ulus Children's Hospital · Academic / Other
• Sex: All
• Age: 30 Days
• Healthy volunteers: Accepted

Summary

Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium lactis, the addition of chicory inulin, in the other group given placebo; Patients taking weekly blood cultures, the presence of residues in both groups during feeding, to evaluate the incidence of NEC and sepsis are planned. Randomization and the number of patients planned to separate into groups.

Detailed description

Patients separated into four groups using the sealed envelope method.

Conditions

• Necrotizing Enterocolitis
• Sepsis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bifidobacterium lactis	5 billion active Bifidobacterium lactis
DIETARY_SUPPLEMENT	Bifidobacterium lactis plus İnülin	5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given
OTHER	Maltodextrin	Maltodextrin
DIETARY_SUPPLEMENT	İnulin	900 mg inulin per day will be given

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-10-01
• Completion: 2013-12-01
• First posted: 2013-03-08
• Last updated: 2013-03-08

Locations

4 sites across 1 country: Turkey (Türkiye)