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
Among 11 studies in Systemic Inflammatory Response Syndrome with a site in Spain — 2 open to participants now, 2 under way, none of them phase 3. Systemic Inflammatory Response Syndrome · Spain.
Among the 11 studies in Systemic Inflammatory Response Syndrome with a site in Spain, this one is the only one that started in 2017, is one of 2 with no phase, and was the 6th registered.
195 studies on the registry are indexed under Systemic Inflammatory Response Syndrome; 24 are open to participants now.
Browse Systemic Inflammatory Response Syndrome studies →2 of the 11 studies in Systemic Inflammatory Response Syndrome with a site in Spain are open now. Recruiting first, the newest first:
PEACHES BIOTECH · Sites in Spain
Ages 18+
Hospital General Universitario Gregorio Marañon · Sites in Spain
Ages 18–65
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 20 Systemic Inflammatory Response Syndrome studies recruiting now, 13 (65%) set no upper age limit and 4 (20%) stop at 75 or younger; 5 take children under 18; none take healthy volunteers.
This study: Up to 32 Weeks · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 1991; this study’s year is marked. 1 started in 2017.
This study's planned enrollment of 120 is above the median of 76 across 98 interventional studies indexed under Systemic Inflammatory Response Syndrome.
Median enrollment 199 across the 7 interventional studies, 460 across the 4 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.
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4 of 11 have an industry lead sponsor. The 10 most frequent:
Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 79 studies on the registry; 19 are open to participants now.
Maimónides Biomedical Research Institute of Córdoba has 1 study filed under Systemic Inflammatory Response Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Systemic Inflammatory Response Syndrome with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Open under request.
Access criteria: To obtain the data, a proposal must be sent to uicec@imibic.org. To gain access, data requestors will need to sign a data access agreement.
No publications or documents are linked to this record.
Started May 2017 (actual). Primary completion is estimated for Mar 2020, 33 months after the start.
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This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Systemic Inflammatory Response Syndrome →
Maimónides Biomedical Research Institute of Córdoba