LACTOPREM: 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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Arm 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)
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.
|
| Placebo Comparator: Control Arm 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
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).
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).
- 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.
- 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.
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hosìtal Universitario Reina Sofia | Córdoba | Spain | 14004 |
Sponsors and Collaborators
- Maimónides Biomedical Research Institute of Córdoba
Investigators
- Principal Investigator: María Dolores Ordoñez, Maimónides Biomedical Research Institute of Córdoba
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FCO-LAC-2016-01