An interventional study of High dose group and Low dose group in Premature Infants and Necrotizing Enterocolitis, sponsored by José Antonio Hurtado Suazo. Completed at 1 site in Spain. Open to participants aged Up to 72 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-15.
Sponsored by José Antonio Hurtado Suazo · Not applicable, Interventional, and Prevention
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 583 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →This is the only study on the registry with José Antonio Hurtado Suazo as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: High 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
Dietary Supplement: Low 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
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
Incidence of necrotizing enterocolitis and all-cause mortality
The primary objective of the study was to determine the incidence of necrotizing enterocolitis (modified Bell classification stages II and III) and all-cause mortality during hospital stay in both intervention groups.
Time frame: From birth until three months
Intestinal colonization by administered strains
Time frame: From birth until three months
Incidence of Late Onset Sepsis
Incidence of Late Onset Sepsis. In accordance with the criteria used by the Castrillo Group for neonatal infections in Spain (compatible clinical symptoms, elevation of water-phase reactants and positive blood culture)
Time frame: From birth until three months
Time to complete enteral nutrition
Time to reach complete enteral nutrition 140 ml/kg/day
Time frame: From birth until three months
Days of Central Vascular Catheter
Time frame: From birth until three months
Length of hospital stay
Days of hospital stay
Time frame: From birth until three months
Weight change
Time frame: From birth until three months
Incidence of Bronchopulmonary Dysplasia
Time frame: From birth until three months
Incidence of patent ductus arteriosus
Time frame: From birth until three months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2015 to primary completion in Jan 2015, 0 months.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 0 months is below that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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