Health TrialsbyHealthPanel

Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants

ConditionNecrotizing Enterocolitis (NEC)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-72
SponsorUniversity of Calgary

About this trial

The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) in preterm infants born at less than 32 weeks of gestation. The main questions it aims to answer are:

* Does the use of a multi-strain probiotic combination reduce the incidence of NEC in preterm infants? * Are there any adverse effects associated with the administration of this probiotic combination?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants born between <32 0/7 weeks gestation.

Disqualifiers

Major congenital or chromosomal abnormalities

Conditions affecting gastrointestinal systems that prohibit infants from starting on feed in the first 72 hours after birth.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Multi-strain probiotics

    Biological/Vaccine

    Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed.

Treatment groups

2,170 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Multi-strain probioticsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of necrotizing enterocolitis (NEC

NEC defined in CNN according to modified Bell's criteria.

Time frame
From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first

Secondary outcomes

1

Survival

Time frame
From date of randomization until the date of 34 weeks corrected gestational age
2

Late-onset sepsis

Culture proven late onset sepsis

Time frame
From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
3

Growth anthropometrics at 36 weeks corrected gestation

Z scores of weight and head circumference

Time frame
at 36 weeks corrected age or discharge from level III NICU whichever occure first.
4

Time to achieve full enteral feed

Defined by reaching 140 mL/kg/day sustained for three consecutive days

Time frame
From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first

Other outcomes

1

Probiotic sepsis

Culture proven sepsis by one of the probiotics products

Time frame
birth to discharge from level III NICU or 34 weeks corrected age whichever comes first

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: