Back to resultsClinical 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. (LACTOPREM)
Primary Purpose
SEPSIS SYNDROME
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Enteral administration of bovine lactoferrin (bLf)
Enteral administration of placebo
Sponsored by
About this trial
This is an interventional treatment trial for SEPSIS SYNDROME focused on measuring bovine lactoferrin, late sepsis
Eligibility 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.
Sites / Locations
- Hosìtal Universitario Reina SofiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Arm
Control Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Perinatal history and demographic characteristics
Description of the perinatal history and demographic characteristics in the subjects of two intervention groups (lactoferrin vs placebo).
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
Adverse effects
Evaluation of the safety of the administration of lactoferrin by monitoring possible adverse effects.
Parameters of inflammation and oxidative stress
Biomonitoring parameters of inflammation and oxidative stress in both groups, comparing possible differences.
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.
Subgroups evaluation
Analyze the results based on subgroups established by gestational age, birth weight, type of feeding and etiology of sepsis.
Anthropometric parameters and neurodevelopment
Evaluation of anthropometric parameters and neurodevelopment at 2 years of corrected age.
Full Information
NCT ID
NCT03472170
First Posted
March 14, 2018
Last Updated
November 11, 2019
Sponsor
Maimónides Biomedical Research Institute of Córdoba
1. Study Identification
Unique Protocol Identification Number
NCT03472170
Brief 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.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SEPSIS SYNDROME
Keywords
bovine lactoferrin, late sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Enteral administration of bovine lactoferrin (bLf)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enteral administration of placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incidence of proven and probable late sepsis
Description
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
Secondary Outcome Measure Information:
Title
Perinatal history and demographic characteristics
Description
Description of the perinatal history and demographic characteristics in the subjects of two intervention groups (lactoferrin vs placebo).
Time Frame
At baseline.
Title
Morbidities
Description
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
Title
Adverse effects
Description
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).
Title
Parameters of inflammation and oxidative stress
Description
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
Title
Intestinal microbiota
Description
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
Title
Subgroups evaluation
Description
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.
Title
Anthropometric parameters and neurodevelopment
Description
Evaluation of anthropometric parameters and neurodevelopment at 2 years of corrected age.
Time Frame
At 2 years of corrected age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Miguel Luque Pineda
Phone
00 34 957 011 040
Email
uicec@imibic.org
First Name & Middle Initial & Last Name or Official Title & Degree
María Dolores Ordoñez, MD
Email
mdordonezdiaz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Dolores Ordoñez
Organizational Affiliation
Maimónides Biomedical Research Institute of Córdoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hosìtal Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Dolores Ordoñez, MD
Email
mdordonezdiaz@gmail.com
First Name & Middle Initial & Last Name & Degree
María Dolores Ordoñez, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Open under request.
IPD Sharing 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.
Learn more about this trial
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.
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