An interventional study of Enteral administration of bovine lactoferrin (bLf) and Enteral administration of placebo in SEPSIS SYNDROME, sponsored by Maimónides Biomedical Research Institute of Córdoba. Status unknown at 1 site in Spain. Open to participants aged Up to 32 Weeks. Per ClinicalTrials.gov, last updated 2019-11-14.
Sponsored by Maimónides Biomedical Research Institute of Córdoba · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
The nutritional supplement used will be bovine lactoferrin, a product marketed according to the regulations of the European Union, and approved by the European Food Safety Agency (EFSA) in 2012, and by the American Agency for Food and Drug Administration ( FDA) in 2013. It will be acquired after purchase from Dicofarm® (Rome, Italy). The Hospital Pharmacy Service will provide the established dose of lactoferrin, according to the administration schedule of 150 mg / kg / day (maximum 300 mg / day). The treatments will be administered in liquid form, in the least amount possible. The administration of lactoferrin 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 NB with EG ≤ 28 weeks and / or birth weight ≤ 1000 gr, or until discharge if this happens before.
Dietary Supplement: Enteral administration of bovine lactoferrin (bLf)
Placebo with similar visual and taste characteristics to the nutritional supplement of bovine lactoferrin. It will be administered in liquid form, in the least amount possible. The administration of 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 NB with EG ≤ 28 weeks and / or birth weight ≤ 1000 gr, or until discharge if this happens before.
Other: Enteral administration of placebo
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.
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).
Incidence of proven and probable late sepsis
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.
Time frame: 12 months
Perinatal history and demographic characteristics
Description of the perinatal history and demographic characteristics in the subjects of two intervention groups (lactoferrin vs placebo).
Time frame: At baseline.
Morbidities
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
Time frame: From 72 hours until 4 weeks after birth
Adverse effects
Evaluation of the safety of the administration of lactoferrin by monitoring possible adverse effects.
Time frame: From 72 hours until 4 weeks after birth and in every visit (months 3, 6, 12 y 24 after hospital discharge).
Parameters of inflammation and oxidative stress
Biomonitoring parameters of inflammation and oxidative stress in both groups, comparing possible differences.
Time frame: 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
Intestinal microbiota
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.
Time frame: Before and after treatment
Subgroups evaluation
Analyze the results based on subgroups established by gestational age, birth weight, type of feeding and etiology of sepsis.
Time frame: At the end of the trial.
Anthropometric parameters and neurodevelopment
Evaluation of anthropometric parameters and neurodevelopment at 2 years of corrected age.
Time frame: At 2 years of corrected age
Plan to share: Yes — The individual participant data will be available. Individual parcicipant data that underlie the results reportes in this article, after deidenttification (text, tables, figures and appendices) The other documents that will be available: study protocol, Statistical Analysis Plan, Informed Consent Form. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? for individual participant data meta-analysis.
Supporting information: Study protocol, Sap, Icf, Csr
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Maimónides Biomedical Research Institute of Córdoba