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NCT01807858 Clinical Trial

The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

Sepsis Clinical Trial

Official title:
The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01807858
Other study ID # 68/16.Oct.2012
Secondary ID
Status Unknown status
Phase N/A
First received December 24, 2012
Last updated March 7, 2013
Start date October 2012
Est. completion date December 2013

Study information
Verified date March 2013
Source Dr. Sami Ulus Children's Hospital
Contact Dilek Dilli, Assoc Prof
Phone 00903123055000
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Patients separated into four groups using the sealed envelope method.

Recruitment information / eligibility
Status Unknown status
Enrollment 400
Est. completion date December 2013
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 30 Days
Eligibility Inclusion Criteria:

- VLBW infants admitted to NICU at the first 7 days of life

Exclusion Criteria:

- expected life lower than 7 days,

- babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.),

- severe asphyxia,

- severe congenital anomaly

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Bifidobacterium lactis
5 billion active Bifidobacterium lactis
• Bifidobacterium lactis plus Inülin
5 billion Bifidobacterium lactis plus 900 mg Inülin per day will be given
Other:
• Maltodextrin
Maltodextrin
Dietary Supplement:
• Inulin
900 mg inulin per day will be given

Locations
Country Name City State
Turkey Sevket Yilmaz Research Hospital Bursa
Turkey Diyarbakir Research Hospital Diyarbakir
Turkey Okmeydani Research Hospital Istanbul
Turkey Umraniye Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Fouhy F, Ross RP, Fitzgerald GF, Stanton C, Cotter PD. Composition of the early intestinal microbiota: knowledge, knowledge gaps and the use of high-throughput sequencing to address these gaps. Gut Microbes. 2012 May-Jun;3(3):203-20. doi: 10.4161/gmic.20169. Epub 2012 May 1. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Necrotizing enterocolitis Developing of >= grade 2 necrotizing enterocolitis suggested by radiological investigation 8 weeks
Secondary length of hospital stay length of hospital stay 16 weeks
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