Probiotics for Preterm Infants

NCT ID: NCT06885944

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-30

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Infant Feeding Outcomes Probiotic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Preterm infants receiving probiotics

Probiotic mix preparation

Intervention Type DIETARY_SUPPLEMENT

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

Bifidobacteria

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probiotic mix preparation

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

Intervention Type DIETARY_SUPPLEMENT

Bifidobacteria

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

\-
Minimum Eligible Age

7 Days

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fuat Emre Canpolat

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

FUAT EMRE CANPOLAT, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Seray Ozturk, MD

Role: CONTACT

+905310843200

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ABSH-Neo-Pro1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Probiotic for Infants
NCT07054216 RECRUITING NA
Probiotics After Discharge
NCT02695784 UNKNOWN PHASE4