Preterm Infant Feeding OutcomesNCT06885944
Probiotics for Preterm Infants
An observational study of Preterm Infant Feeding Outcomes and Probiotic, run by Ankara City Hospital Bilkent.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 3 months
- Conditions the study is for
- Preterm Infant Feeding Outcomes, Probiotic
- What is being tested?
- Probiotic mix preparation and Bifidobacteria
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2025to 30 Nov 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: preterm infants with a gestational age lower than 32 weeks and 1500 g of birthweight, reached to fully enteral feeds
Who may be able to join
- Exclusion Criteria: Congential anomalies, still parenteral feeding, BW<800 gr and <23 weeks of GA
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Probiotics for Preterm Infants After Full Enteral Feeding
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.
Read the 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.
- Conditions
- Preterm Infant Feeding Outcomes, Probiotic
- Being tested
- Probiotic mix preparation, Bifidobacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic mix preparationDietary supplement
Bifidobacterium containing supplement with vitamin D will start after preterm infants reaches full enteral feeding
BifidobacteriaDietary supplement
Rather than early period we will start probiotics after infant receive full enteral feedings
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Preterm infants receiving probiotics Receives: Dietary Supplement: Probiotic mix preparation; Dietary Supplement: Bifidobacteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antropometric measures
daily weight gain mg/kg/day
Measured: 2 months
Secondary outcomes (1)
Metabolic profile
Ca, P, ALP, Urea and biochmeical markers for nutritional status
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start30 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Infant Feeding OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuat Emre Canpolat, Ankara City Hospital Bilkent
- Investigators
- FUAT EMRE CANPOLAT, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885944
- Sponsor's protocol ID
- ABSH-Neo-Pro1
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Preterm Infants After Full Enteral Feeding
- ClinicalTrials.gov ID
- NCT06885944
- Acronym / sponsor ID
- ABSH-Neo-Pro1
- Conditions
- Preterm Infant Feeding Outcomes, Probiotic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Dietary Supplement: Probiotic mix preparation, Dietary Supplement: BifidobacteriaPreterm infants receiving probiotics |
Who may qualify
- Ages
- 7 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- preterm infants with a gestational age lower than 32 weeks and 1500 g of birthweight, reached to fully enteral feeds
Key inclusion criteria (2 listed)
- Exclusion Criteria: Congential anomalies, still parenteral feeding, BW<800 gr and <23 weeks of GA
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic mix preparationBifidobacterium containing supplement with vitamin D will start after preterm infants reaches full enteral feeding | Dietary supplement | Group 1 |
| BifidobacteriaRather than early period we will start probiotics after infant receive full enteral feedings | Dietary supplement | Group 1 |
Primary outcome
Antropometric measures
Time frame: 2 months
daily weight gain mg/kg/day
1 secondary outcome
Metabolic profile
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FUAT EMRE CANPOLAT, MD principal investigator
Ankara City Hospital Bilkent
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infant Feeding Outcomes and Probiotic, run by Ankara City Hospital Bilkent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seray Ozturk, MD (+905310843200, serayakbag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antropometric measures (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025; AzTrials last refreshed its copy on 27 Oct 2026.