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.

NAUnknownINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 4, 2017

Primary Completion Date

March 1, 2020

Study Completion Date

March 1, 2020

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).

Trial Locations (1)

14004

RECRUITING

Hosìtal Universitario Reina Sofia, Córdoba

All Listed Sponsors
lead

Maimónides Biomedical Research Institute of Córdoba

OTHER