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.

SEPSIS SYNDROME Clinical Trial

— LACTOPREM  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03472170
• Other study ID #: FCO-LAC-2016-01
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: November 2019
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: Antonio Miguel Luque Pineda
• Phone: 00 34 957 011 040
• Email: uicec[@]imibic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• SEPSIS SYNDROME
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

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.

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).

Locations

Country	Name	City	State
Spain	Hosìtal Universitario Reina Sofia	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Perinatal history and demographic characteristics	Description of the perinatal history and demographic characteristics in the subjects of two intervention groups (lactoferrin vs placebo).	At baseline.
Secondary	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	From 72 hours until 4 weeks after birth
Secondary	Adverse effects	Evaluation of the safety of the administration of lactoferrin by monitoring possible adverse effects.	From 72 hours until 4 weeks after birth and in every visit (months 3, 6, 12 y 24 after hospital discharge).
Secondary	Parameters of inflammation and oxidative stress	Biomonitoring parameters of inflammation and oxidative stress in both groups, comparing possible differences.	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
Secondary	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.	Before and after treatment
Secondary	Subgroups evaluation	Analyze the results based on subgroups established by gestational age, birth weight, type of feeding and etiology of sepsis.	At the end of the trial.
Secondary	Anthropometric parameters and neurodevelopment	Evaluation of anthropometric parameters and neurodevelopment at 2 years of corrected age.	At 2 years of corrected age