Clinical trial NCT03472170: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SEPSIS SYNDROME
Keywords: bovine lactoferrin
late sepsis
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 120
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: To date there are no published clinical data that jointly assess the impact of direct Lf supplementation on oxidative status, on biomarkers of systemic inflammation and on the microbiota of premature infants with or without sepsis. Clarification of these additional questions is essential for a better understanding of the benefits and implications of enteral administration of Lf in preterm infants. The enteral administration of lactoferrin reduces the incidence of late sepsis in preterm infants of very low birth weight (BMPN). Enteral supplementation with lactoferrin in NBWNS can have a beneficial effect on the systemic oxidative and inflammatory state, and may contribute to the creation of a healthy faecal microbiota.

Eligibility criteria: Inclusion Criteria:

* Both groups will include male or female children born preterm with birth weight ≤ 1500 g and / or EG ≤ 32 weeks. All tutors of patients, must sign the informed consent.

Exclusion Criteria:

* In both groups those subjects who do not meet the age and weight established at birth, have\> 72 hours of life at the time of inclusion, who do not sign informed consent or who have the following morbidities will be discarded: 1) Early sepsis or vertical; 2) Gastrointestinal congenital anomalies; 3) Chromosomopathies; 4) Congenital anomalies and / or genetic diseases without survival expectations; 5) Severe perinatal hypoxia.

Primary outcomes:
measure: Incidence of proven and probable late sepsis
timeFrame: 12 months
Secondary outcomes:
measure: Perinatal history and demographic characteristics
timeFrame: At baseline.
measure: Morbidities
timeFrame: From 72 hours until 4 weeks after birth
measure: Adverse effects
timeFrame: From 72 hours until 4 weeks after birth and in every visit (months 3, 6, 12 y 24 after hospital discharge).
measure: Parameters of inflammation and oxidative stress
timeFrame: 0-24 hours of life, 7-10 days, 14-17 days of life, and one last extraction at the end of treatment, at 28-31 days
measure: Intestinal microbiota
timeFrame: Before and after treatment
measure: Subgroups evaluation
timeFrame: At the end of the trial.
measure: Anthropometric parameters and neurodevelopment
timeFrame: At 2 years of corrected age
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hosìtal Universitario Reina Sofia
Study officials:
affiliation: Maimónides Biomedical Research Institute of Córdoba
name: María Dolores Ordoñez
role: PRINCIPAL_INVESTIGATOR
References: