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NCT Number: NCT06885944

Probiotics for Preterm Infants

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.

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Key information

Conditions

Preterm Infant Feeding Outcomes Probiotic

Age range

7 day–3 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

<32 weeks, <1500 g birthweight -

Exclusion criteria

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

-

Treatment and study plan

Probiotic mix preparation

Dietary Supplement

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

Bifidobacteria

Dietary Supplement

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

Primary outcomes

  1. Antropometric measures

    Time frame: 2 months

    daily weight gain mg/kg/day

Secondary outcomes

  1. Metabolic profile

    Time frame: 2 months

    Ca, P, ALP, Urea and biochmeical markers for nutritional status

Study contacts

Contact information is provided by the study sponsor or research team.

Seray Ozturk, MD

CONTACT

[email protected]

+905310843200

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Probiotics for Preterm Infants After Full Enteral Feeding

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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