Probiotics for Preterm Infants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Probiotic; Preterm Infant Feeding Outcomes
• Intervention / Treatment: Dietary supplement: Probiotic mix preparation; Dietary supplement: Bifidobacteria

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Seray Ozturk, MD; Phone Number: +905310843200; Email: serayakbag@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

preterm infants with a gestational age lower than 32 weeks and 1500 g of birthweight, reached to fully enteral feeds

Description

Inclusion Criteria: <32 weeks, <1500 g birthweight -

Exclusion Criteria: Congential anomalies, still parenteral feeding, BW<800 gr and <23 weeks of GA

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Preterm infants receiving probiotics	Dietary supplement: Probiotic mix preparation; Bifidobacterium containing supplement with vitamin D will start after preterm infants reaches full enteral feeding; Dietary supplement: Bifidobacteria; Rather than early period we will start probiotics after infant receive full enteral feedings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antropometric measures	daily weight gain mg/kg/day	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic profile	Ca, P, ALP, Urea and biochmeical markers for nutritional status	2 months

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: FUAT EMRE CANPOLAT, MD, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: ABSH-Neo-Pro1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No