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Clinical Trial for Valuation of the Effectiveness of Lactoferrine in the Prevention of Sepsis in New Premature Born. Bimonitorization of the Antinflammatory Mechanisms, Antioxidants and the Intestinal Microbiote.

NCT03472170 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-11-14

No results posted yet for this study

Summary

To evaluate the efficacy of enteral administration of bovine lactoferrin (bLf) in the reduction of probable late sepsis or microbiologically proven in preterm infants with birth weight ≤ 1500 gr and / or gestational age ≤ 32 weeks.

Conditions

  • SEPSIS SYNDROME

Interventions

DIETARY_SUPPLEMENT

Enteral administration of bovine lactoferrin (bLf)

The pharmacy service of the hospital will provide the established dose of lactoferrin, according to the regimen of administration of 150 mg / kg / day (maximum 300 mg / day), as well as that of placebo. Both treatments will be administered in liquid form, in the least amount possible. Both the administration of lactoferrin and placebo will be carried out enterally, orally or by nasogastric tube. The intervention will be done in the first 72 hours of life, once a day, and for 4 weeks, extending to 6 weeks in the newborns with EG ≤ 28 weeks and / or birth weight ≤ 1000 gr, or until discharge if this happens before.

OTHER

Enteral administration of placebo

Enteral administration of placebo with similar visual and gustatory characteristics in the first 72 hours of life, and for 4 weeks (6 weeks in the RN ≤ 1000 gr and / or EG ≤ 28 weeks).

Sponsors & Collaborators

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Principal Investigators

  • María Dolores Ordoñez · Maimónides Biomedical Research Institute of Córdoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-04
Primary Completion
2020-03-01
Completion
2020-03-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03472170 on ClinicalTrials.gov