Probiotics for Preterm Infants

Not yet recruiting

• Conditions: Preterm Infant Feeding Outcomes; Probiotic

• Registration Number: NCT06885944
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Study Start: 2025-03-30
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

<32 weeks, <1500 g birthweight -

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antropometric measures	2 months	daily weight gain mg/kg/day

Secondary Outcome Measures

Name	Time	Method
Metabolic profile	2 months	Ca, P, ALP, Urea and biochmeical markers for nutritional status