The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01807858

Enrollment

400

Registered

2013-03-08

Start date

2012-10-31

Completion date

2013-12-31

Last updated

2013-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis, Sepsis

Keywords

Necrotizing enterocolitis, Sepsis, Length of hospital stay, Mortality

Brief 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.

Interventions

DIETARY_SUPPLEMENTBifidobacterium lactis

5 billion active Bifidobacterium lactis

DIETARY_SUPPLEMENTBifidobacterium lactis plus İnülin

5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given

OTHERMaltodextrin

Maltodextrin

DIETARY_SUPPLEMENTİnulin

900 mg inulin per day will be given

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 30 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Necrotizing enterocolitis	8 weeks	Developing of \>= grade 2 necrotizing enterocolitis suggested by radiological investigation

Secondary

Measure	Time frame	Description
length of hospital stay	16 weeks	length of hospital stay

Countries

Turkey (Türkiye)

Contacts

Primary ContactDilek Dilli, Assoc Prof

00903123055000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026