SEPSIS SYNDROME
Conditions
Keywords
bovine lactoferrin, late sepsis
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.
Interventions
DIETARY_SUPPLEMENTEnteral 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.
OTHEREnteral 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).
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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). |
| 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. |
| Anthropometric parameters and neurodevelopment | At 2 years of corrected age | Evaluation of anthropometric parameters and neurodevelopment at 2 years of corrected age. |
| 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. |
Countries
Spain
Contacts
Primary ContactAntonio Miguel Luque Pineda
Backup ContactMaría Dolores Ordoñez, MD
Outcome results
None listed