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.

Not Applicable

• Conditions: SEPSIS SYNDROME

• Registration Number: NCT03472170
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

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.

Study Timeline

• Study Start: 2017-05-04
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-21
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-14
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of proven and probable late sepsis	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Adverse effects	From 72 hours until 4 weeks after birth and in every visit (months 3, 6, 12 y 24 after hospital discharge).	Evaluation of the safety of the administration of lactoferrin by monitoring possible adverse effects.
Subgroups evaluation	At the end of the trial.	Analyze the results based on subgroups established by gestational age, birth weight, type of feeding and etiology of sepsis.
Perinatal history and demographic characteristics	At baseline.	Description of the perinatal history and demographic characteristics in the subjects of two intervention groups (lactoferrin vs placebo).
Parameters of inflammation and oxidative stress	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	Biomonitoring parameters of inflammation and oxidative stress in both groups, comparing possible differences.
Intestinal microbiota	Before and after treatment	Study and compare the composition of the intestinal microbiota between both groups. Its modification will be assessed before and after treatment, and the implication of its distortion in late sepsis.
Anthropometric parameters and neurodevelopment	At 2 years of corrected age	Evaluation of anthropometric parameters and neurodevelopment at 2 years of corrected age.
Morbidities	From 72 hours until 4 weeks after birth	Assess the possible differences between the two groups with respect to the following morbidities: Global mortality and / or attributable to late sepsis before hospital discharge; * Necrotizing enterocolitis; * Retinopathy of prematurity; * Bronchopulmonary dysplasia; * Cerebral hemorrhage and periventricular leukomalacia; * Hospital stay; * Seriousness of late sepsis; * Food tolerance

Trial Locations

Locations (1)

Hosìtal Universitario Reina Sofia; 🇪🇸 Córdoba, Spain