NCT06501404

PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis

Effects of Probiotic Supplementation During the Neonatal Period on the Preterm Infant

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 583 (actual)
• Sponsor: José Antonio Hurtado Suazo · Academic / Other
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Accepted

Summary

The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.

Conditions

• Premature Infants
• Necrotizing Enterocolitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High dose group	A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains
DIETARY_SUPPLEMENT	Low dose group	A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains

Timeline

• Start date: 2015-01-10
• Primary completion: 2015-01-15
• Completion: 2020-03-20
• First posted: 2024-07-15
• Last updated: 2024-07-15

Locations

1 site across 1 country: Spain