Menu
Not yet recruiting NCT06885944

Probiotics for Preterm Infants

Observational Preterm Infant Feeding Outcomes Probiotic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Probiotic mix preparation, Bifidobacteria.
Who it may be relevant to
Registry conditions: Preterm Infant Feeding Outcomes, Probiotic. Basic parameters: 7 Days — 3 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Probiotics for Preterm Infants After Full Enteral Feeding

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Antropometric measures [Time frame: 2 months]
Secondary outcome measures (1)
  • Metabolic profile [Time frame: 2 months]

Eligibility criteria

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

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06885944 · ABSH-Neo-Pro1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗