Study the Safety and Efficacy of Probiotics Use in Premature Infants

NCT01891604 | Withdrawn DMC

• 1 other identifier: jamesfriel2013
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm infants' health, and may also play a role in reducing NEC and associated morbidity.

Conditions

Infant, Premature, Diseases

Outcome Measures

Primary Outcomes (1)

• Calprotectin will be used to determine the effect for probiotics

  day1 and day30 of the observation

Interventions

breast milk with Bifidobacterium Longum subp. Infantis R0033 DIETARY_SUPPLEMENT

breast milk DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: Up to 2 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• born with weight\<1500 g
• hospitalized within 48 hours after birth

You may not qualify if:

• present with evidence or suspicion of congenital intestinal obstruction
• perforation
• gastroschisis
• large omphalocele
• congenital diaphragmatic hernia
• major congenital heart defects

Sponsors & Collaborators

• University of Manitoba: lead
• Lallemand Health Solutions: collaborator

MeSH Terms

Conditions

Infant, Premature, Diseases

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 3, 2013
• Primary Completion: December 1, 2016
• Last Updated: May 12, 2017

Record last verified: 2017-05