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Probiotics for Preterm Infants

Probiotics for Preterm Infants After Full Enteral Feeding

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06885944
Enrollment
100
Registered
2025-03-20
Start date
2025-03-30
Completion date
2025-11-30
Last updated
2025-03-20

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

Conditions

Preterm Infant Feeding Outcomes, Probiotic

Brief summary

Probiotics will be used for preterm infants under 32 weeks of gestation and under 1500 g birthweight. Our aim was to investigate the effects of probiotics for stable preterm infants after extubation and who reached full enteral feeding. There are some hesitations among care-givers to start probiotics early due to safety issues although there are many positive effects of these products reported int the literature.

Detailed description

Our study included premature babies with a birth weight of less than 1500 grams, born at less than 32 weeks of gestation, and without congenital anomalies. Approval was obtained from the hospital's clinical research ethics committee before starting the study. The decision to start probiotics was made when these premature babies were fully enteral fed. The study design was created as a cohort and case-control study (No randomisation). When clinicians decided to start probiotic support for premature babies with good general health and no additional problems, probiotics were added to the baby's order.

Interventions

DIETARY_SUPPLEMENTProbiotic mix preparation

Bifidobacterium containing supplement with vitamin D will start after preterm infants reaches full enteral feeding

DIETARY_SUPPLEMENTBifidobacteria

Rather than early period we will start probiotics after infant receive full enteral feedings

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Days to 3 Months
Healthy volunteers
No

Inclusion criteria

\<32 weeks, \<1500 g birthweight -

Exclusion criteria

Congential anomalies, still parenteral feeding, BW\<800 gr and \<23 weeks of GA \-

Design outcomes

Primary

MeasureTime frameDescription
Antropometric measures2 monthsdaily weight gain mg/kg/day

Secondary

MeasureTime frameDescription
Metabolic profile2 monthsCa, P, ALP, Urea and biochmeical markers for nutritional status

Contacts

Primary ContactSeray Ozturk, MD
serayakbag@gmail.com+905310843200

Outcome results

None listed

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