Late Onset Neonatal SepsisPhase 3NEOLACTONCT01525316
Lactoferrin for Prevention of Sepsis in Infants
A Phase 3 study testing Bovine Lactoferrin and Maltodextrin in people with Late Onset Neonatal Sepsis, run by Universidad Peruana Cayetano Heredia at 3 sites in Peru.
Trial summary
The investigators propose a clinical trial in premature infants to determine the effect of orally-administered bovine lactoferrin on occurrence of severe infections and to determine whether as a result of decreased infections, infants' growth and development improve after daily lactoferrin supplementation, due to its… Read more about this study
- Who is it for?
- Ages 1 hour to 72 hours
- Conditions the study is for
- Late Onset Neonatal Sepsis
- What is being tested?
- Bovine Lactoferrin and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 414 participants
- Where
- 3 sitesPeru
- Study dates
- May 2012to Oct 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with a birth weight between 500g and 2000g
- Neonates born in, or referred to the Neonatal Intermediate and Intensive Care Units of one of the participating hospitals in the first 72 hours of life.
Who cannot join
- Neonates with underlying gastrointestinal problems that prevent oral intake.
- Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities).
- Neonates who have a family history of cow milk allergy.
- Neonates that, according to the investigator criteria, will not have the chance to complete the subsequent study visits (patients that before one month old would not be living in Lima).
- Neonates whose parents decline to participate.
Trial locations and contacts
3 sites in 1 country.
Peru3 sites
Hospital Nacional Alberto Sabogal Sologuren
Lima, 0511
Hospital Nacional Cayetano Heredia
Lima, 0511
Hospital Nacional Guillermo Almenara Irigoyen
Lima, 0511
About this study
The investigators propose a clinical trial in premature infants to determine the effect of orally-administered bovine lactoferrin on occurrence of severe infections and to determine whether as a result of decreased infections, infants' growth and development improve after daily lactoferrin supplementation, due to its antimicrobial and anti-inflammatory properties. If successful, the use of lactoferrin as a protective protein could profoundly affect clinical care of neonates both in the developed and developing world.
Read the detailed description
Neonatal mortality is an important global public health challenge. Approximately 4 million neonatal deaths per year occur in developing countries, accounting for 40% all of deaths in children under 5. Infection, birth asphyxia and consequences of premature birth/low birth weight are responsible for the majority of these deaths. Although advances in neonatal intensive care led to improved survival of premature infants, sepsis continues to be an important cause of morbidity and mortality worldwide.
Lactoferrin, an iron-binding protein with multiple physiological functions (anti-microbial, anti-inflammatory, and immunomodulatory), is one of the most important proteins present in mammalian milk. Our hypothesis is that lactoferrin given as a daily oral food supplement to preterm infants will improve their health by mimicking its protective role in milk. There is a vast literature showing in vitro and animal model benefits of lactoferrin. However, there are few clinical studies designed to translate this knowledge into patient care. A recent Italian study showed that lactoferrin given to low-birth weight infants reduces incidence of sepsis (17% vs. 6%) and death. Whether lactoferrin has an effect in higher risk populations and an impact on subsequent neurodevelopment and growth remains to be determined.
Specific aim 1: The investigators will test the hypothesis that bovine lactoferrin supplementation prevents serious infections in preterm infants. The investigators will conduct a randomized placebo-controlled double blind study in 414 premature infants < 2000 g in Neonatal Units in Lima, Peru to determine whether bovine lactoferrin prevents late-onset sepsis or sepsis-associated death.
This hypothesis is based on lactoferrin´s antimicrobial and immunomodulating activities. Lactoferrin protects against pathogens in multiple ways: it sequesters iron essential for bacterial growth; binds to lipopolysaccharide (LPS) on the cell surface of Gram negative bacteria, disrupting the bacterial cell membrane; it has anti-lipoteichoic acid (against Gram positive organisms) and anti-Candida cell wall activities. The investigators have found that lactoferrin not only inhibits growth; it impairs virulence of some of the major pathogens by decreasing their ability to adhere or to invade mammalian cells, and by binding to, or degrading, specific virulence proteins. Lactoferrin may protect infants from sepsis by blocking attachment and invasion of organisms in the gut.
Specific aim 2: The investigators will test the hypothesis that bovine lactoferrin supplementation promotes better neurodevelopment and growth outcomes in preterm infants assessed by the Mullen Scales of Early Learning, a standardized neurologic exam and growth measurements at 12, 18 and 24 months corrected age.
It is postulated that exposure of the preterm brain to inflammatory mediators during infectious episodes contribute to brain (white matter) injury and poor developmental outcome. It has been demonstrated that breast milk has a beneficial effect on neurodevelopment outcomes in preterm infants. The investigators hypothesize that lactoferrin is the major factor in milk responsible for this effect due to its antimicrobial and immunomodulatory properties: it reduces inflammation by decreasing production of tumor necrosis factor α and other pro-inflammatory molecules, and by regulating the immune response, protecting against severe inflammation related to infection and septic shock. In addition, the investigators hypothesize that lactoferrin will improve growth by decreasing the frequency of growth-impairing infections and by lactoferrin effect on intestinal cell proliferation, differentiation and maturation.
The use of lactoferrin as a broad-spectrum non-pathogen specific antimicrobial protective protein is an innovative approach. If successful this study will profoundly affect clinical care of neonates both in the developed and developing world.
- Conditions
- Late Onset Neonatal Sepsis
- Being tested
- Bovine Lactoferrin, Maltodextrin
- Keywords
- Late Onset Neonatal Sepsis, Neonates, Lactoferrin, Infections, Prevention, Neurodevelopment
- Medical subject headings
- Neonatal Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine LactoferrinDietary supplement
Also called Lactoferrin
Infants will receive oral bovine lactoferrin (200 mg/Kg/day divided in three dosis) for 8 weeks. Lactoferrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum lactoferrin concentration will be 25mg/mL.
MaltodextrinDietary supplement
Infants will receive oral maltodextrin (200mg/Kg/day in three divided dosis) for 8 weeks. Maltodextrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum maltodextrin concentration will be 25mg/mL.
| Study group | Role | What they receive |
|---|---|---|
| Bovine Lactoferrin | Experimental | Lactoferrin is a freeze-dried protein purified directly from fresh bovine milk. Receives: Dietary Supplement: Bovine Lactoferrin |
| Maltodextrin | Placebo comparator | Maltodextrin is an inert sugar. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
First episode of late-onset sepsis or sepsis-associated death
The primary study outcome will be a composite outcome of the first episode of late-onset sepsis or sepsis-associated death.
Measured: 72hrs to 8 weeks of age
Secondary outcomes (1)
Neurodevelopment
Neurodevelopment at 24 months of corrected age, assessed by the Mullen Scale for Early Learning.
Measured: 12 to 24 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Late Onset Neonatal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Theresa J Ochoa, MD, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525316
- Sponsor's protocol ID
- SIDISI 57710
- Other IDs
- 1R01HD067694-01A1
- Acronym
- NEOLACTO
- Status last verified
- Dec 2021
- First submitted
- 30 Jan 2012
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manzoni P, Rinaldi M, Cattani S, Pugni L, Romeo MG, Messner H, Stolfi I, Decembrino L, Laforgia N, Vagnarelli F, Memo L, Bordignon L, Saia OS, Maule M, Gallo E, Mostert M, Magnani C, Quercia M, Bollani L, Pedicino R, Renzullo L, Betta P, Mosca F, Ferrari F, Magaldi R, Stronati M, Farina D; Italian Task Force for the Study and Prevention of Neonatal Fungal Infections, Italian Society of Neonatology. Bovine lactoferrin supplementation for prevention of late-onset sepsis in very low-birth-weight neonates: a randomized trial. JAMA. 2009 Oct 7;302(13):1421-8. doi: 10.1001/jama.2009.1403.
PubMed 19809023Ochoa TJ, Zegarra J, Cam L, Llanos R, Pezo A, Cruz K, Zea-Vera A, Carcamo C, Campos M, Bellomo S; NEOLACTO Research Group. Randomized controlled trial of lactoferrin for prevention of sepsis in peruvian neonates less than 2500 g. Pediatr Infect Dis J. 2015 Jun;34(6):571-6. doi: 10.1097/INF.0000000000000593.
PubMed 25973934Akin IM, Atasay B, Dogu F, Okulu E, Arsan S, Karatas HD, Ikinciogullari A, Turmen T. Oral lactoferrin to prevent nosocomial sepsis and necrotizing enterocolitis of premature neonates and effect on T-regulatory cells. Am J Perinatol. 2014 Dec;31(12):1111-20. doi: 10.1055/s-0034-1371704. Epub 2014 May 16.
PubMed 24839144Torres Roldan VD, Urtecho S M, Gupta J, Yonemitsu C, Carcamo CP, Bode L, Ochoa TJ. Human milk oligosaccharides and their association with late-onset neonatal sepsis in Peruvian very-low-birth-weight infants. Am J Clin Nutr. 2020 Jul 1;112(1):106-112. doi: 10.1093/ajcn/nqaa102.
PubMed 32401307Ochoa TJ, Zegarra J, Bellomo S, Carcamo CP, Cam L, Castaneda A, Villavicencio A, Gonzales J, Rueda MS, Turin CG, Zea-Vera A, Guillen D, Campos M, Ewing-Cobbs L; NEOLACTO Research Group. Randomized Controlled Trial of Bovine Lactoferrin for Prevention of Sepsis and Neurodevelopment Impairment in Infants Weighing Less Than 2000 Grams. J Pediatr. 2020 Apr;219:118-125.e5. doi: 10.1016/j.jpeds.2019.12.038. Epub 2020 Feb 6.
PubMed 32037149Medina-Alva P, Duque KR, Zea-Vera A, Bellomo S, Carcamo C, Guillen-Pinto D, Rivas M, Tori A, Zegarra J, Cam L, Castaneda A, Villavicencio A, Ochoa TJ. Combined predictors of neurodevelopment in very low birth weight preterm infants. Early Hum Dev. 2019 Mar;130:109-115. doi: 10.1016/j.earlhumdev.2019.01.019. Epub 2019 Feb 8.
PubMed 30743197Rueda MS, Calderon-Anyosa R, Gonzales J, Turin CG, Zea-Vera A, Zegarra J, Bellomo S, Cam L, Castaneda A, Ochoa TJ; NEOLACTO Research Group. Antibiotic Overuse in Premature Low Birth Weight Infants in a Developing Country. Pediatr Infect Dis J. 2019 Mar;38(3):302-307. doi: 10.1097/INF.0000000000002055.
PubMed 29613975Turin CG, Zea-Vera A, Rueda MS, Mercado E, Carcamo CP, Zegarra J, Bellomo S, Cam L, Castaneda A, Ochoa TJ; NEOLACTO Research Group. Lactoferrin concentration in breast milk of mothers of low-birth-weight newborns. J Perinatol. 2017 May;37(5):507-512. doi: 10.1038/jp.2016.265. Epub 2017 Jan 26.
PubMed 28125095
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactoferrin for Prevention of Sepsis in Infants
- ClinicalTrials.gov ID
- NCT01525316
- Acronym / sponsor ID
- NEOLACTO / SIDISI 57710
- Conditions
- Late Onset Neonatal Sepsis
- Keywords
- Late Onset Neonatal Sepsis, Neonates, Lactoferrin, Infections, Prevention, Neurodevelopment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a clinical trial in premature infants to determine the effect of orally-administered bovine lactoferrin on occurrence of severe infections and to determine whether as a result of decreased infections, infants' growth and development improve after daily lactoferrin supplementation, due to its antimicrobial and anti-inflammatory properties. If successful, the use of lactoferrin as a protective protein could profoundly affect clinical care of neonates both in the developed and developing world.
Detailed description
Neonatal mortality is an important global public health challenge. Approximately 4 million neonatal deaths per year occur in developing countries, accounting for 40% all of deaths in children under 5. Infection, birth asphyxia and consequences of premature birth/low birth weight are responsible for the majority of these deaths. Although advances in neonatal intensive care led to improved survival of premature infants, sepsis continues to be an important cause of morbidity and mortality worldwide.
Lactoferrin, an iron-binding protein with multiple physiological functions (anti-microbial, anti-inflammatory, and immunomodulatory), is one of the most important proteins present in mammalian milk. Our hypothesis is that lactoferrin given as a daily oral food supplement to preterm infants will improve their health by mimicking its protective role in milk. There is a vast literature showing in vitro and animal model benefits of lactoferrin. However, there are few clinical studies designed to translate this knowledge into patient care. A recent Italian study showed that lactoferrin given to low-birth weight infants reduces incidence of sepsis (17% vs. 6%) and death. Whether lactoferrin has an effect in higher risk populations and an impact on subsequent neurodevelopment and growth remains to be determined.
Specific aim 1: The investigators will test the hypothesis that bovine lactoferrin supplementation prevents serious infections in preterm infants. The investigators will conduct a randomized placebo-controlled double blind study in 414 premature infants < 2000 g in Neonatal Units in Lima, Peru to determine whether bovine lactoferrin prevents late-onset sepsis or sepsis-associated death.
This hypothesis is based on lactoferrin´s antimicrobial and immunomodulating activities. Lactoferrin protects against pathogens in multiple ways: it sequesters iron essential for bacterial growth; binds to lipopolysaccharide (LPS) on the cell surface of Gram negative bacteria, disrupting the bacterial cell membrane; it has anti-lipoteichoic acid (against Gram positive organisms) and anti-Candida cell wall activities. The investigators have found that lactoferrin not only inhibits growth; it impairs virulence of some of the major pathogens by decreasing their ability to adhere or to invade mammalian cells, and by binding to, or degrading, specific virulence proteins. Lactoferrin may protect infants from sepsis by blocking attachment and invasion of organisms in the gut.
Specific aim 2: The investigators will test the hypothesis that bovine lactoferrin supplementation promotes better neurodevelopment and growth outcomes in preterm infants assessed by the Mullen Scales of Early Learning, a standardized neurologic exam and growth measurements at 12, 18 and 24 months corrected age.
It is postulated that exposure of the preterm brain to inflammatory mediators during infectious episodes contribute to brain (white matter) injury and poor developmental outcome. It has been demonstrated that breast milk has a beneficial effect on neurodevelopment outcomes in preterm infants. The investigators hypothesize that lactoferrin is the major factor in milk responsible for this effect due to its antimicrobial and immunomodulatory properties: it reduces inflammation by decreasing production of tumor necrosis factor α and other pro-inflammatory molecules, and by regulating the immune response, protecting against severe inflammation related to infection and septic shock. In addition, the investigators hypothesize that lactoferrin will improve growth by decreasing the frequency of growth-impairing infections and by lactoferrin effect on intestinal cell proliferation, differentiation and maturation.
The use of lactoferrin as a broad-spectrum non-pathogen specific antimicrobial protective protein is an innovative approach. If successful this study will profoundly affect clinical care of neonates both in the developed and developing world.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bovine Lactoferrin | Experimental | Dietary Supplement: Bovine LactoferrinLactoferrin is a freeze-dried protein purified directly from fresh bovine milk. |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin is an inert sugar. |
Who may qualify
- Ages
- 1 hour to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Neonates with a birth weight between 500g and 2000g
- Neonates born in, or referred to the Neonatal Intermediate and Intensive Care Units of one of the participating hospitals in the first 72 hours of life.
Key exclusion criteria (5 listed)
- Neonates with underlying gastrointestinal problems that prevent oral intake.
- Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities).
- Neonates who have a family history of cow milk allergy.
- Neonates that, according to the investigator criteria, will not have the chance to complete the subsequent study visits (patients that before one month old would not be living in Lima).
- Neonates whose parents decline to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bovine LactoferrinAlso: LactoferrinInfants will receive oral bovine lactoferrin (200 mg/Kg/day divided in three dosis) for 8 weeks. Lactoferrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum lactoferrin concentration will be 25mg/mL. | Dietary supplement | Bovine Lactoferrin |
| MaltodextrinInfants will receive oral maltodextrin (200mg/Kg/day in three divided dosis) for 8 weeks. Maltodextrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum maltodextrin concentration will be 25mg/mL. | Dietary supplement | Maltodextrin |
Primary outcome
First episode of late-onset sepsis or sepsis-associated death
Time frame: 72hrs to 8 weeks of age
The primary study outcome will be a composite outcome of the first episode of late-onset sepsis or sepsis-associated death.
1 secondary outcome
Neurodevelopment
Time frame: 12 to 24 months of corrected age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Background: PubMed 19809023Manzoni P, Rinaldi M, Cattani S, Pugni L, Romeo MG, Messner H, Stolfi I, Decembrino L, Laforgia N, Vagnarelli F, Memo L, Bordignon L, Saia OS, Maule M, Gallo E, Mostert M, Magnani C, Quercia M, Bollani L, Pedicino R, Renzullo L, Betta P, Mosca F, Ferrari F, Magaldi R, Stronati M, Farina D; Italian Task Force for the Study and Prevention of Neonatal Fungal Infections, Italian Society of Neonatology. Bovine lactoferrin supplementation for prevention of late-onset sepsis in very low-birth-weight neonates: a randomized trial. JAMA. 2009 Oct 7;302(13):1421-8. doi: 10.1001/jama.2009.1403.
- Background: PubMed 25973934Ochoa TJ, Zegarra J, Cam L, Llanos R, Pezo A, Cruz K, Zea-Vera A, Carcamo C, Campos M, Bellomo S; NEOLACTO Research Group. Randomized controlled trial of lactoferrin for prevention of sepsis in peruvian neonates less than 2500 g. Pediatr Infect Dis J. 2015 Jun;34(6):571-6. doi: 10.1097/INF.0000000000000593.
- Background: PubMed 24839144Akin IM, Atasay B, Dogu F, Okulu E, Arsan S, Karatas HD, Ikinciogullari A, Turmen T. Oral lactoferrin to prevent nosocomial sepsis and necrotizing enterocolitis of premature neonates and effect on T-regulatory cells. Am J Perinatol. 2014 Dec;31(12):1111-20. doi: 10.1055/s-0034-1371704. Epub 2014 May 16.
- Derived from this study: PubMed 32401307Torres Roldan VD, Urtecho S M, Gupta J, Yonemitsu C, Carcamo CP, Bode L, Ochoa TJ. Human milk oligosaccharides and their association with late-onset neonatal sepsis in Peruvian very-low-birth-weight infants. Am J Clin Nutr. 2020 Jul 1;112(1):106-112. doi: 10.1093/ajcn/nqaa102.
- Derived from this study: PubMed 32037149Ochoa TJ, Zegarra J, Bellomo S, Carcamo CP, Cam L, Castaneda A, Villavicencio A, Gonzales J, Rueda MS, Turin CG, Zea-Vera A, Guillen D, Campos M, Ewing-Cobbs L; NEOLACTO Research Group. Randomized Controlled Trial of Bovine Lactoferrin for Prevention of Sepsis and Neurodevelopment Impairment in Infants Weighing Less Than 2000 Grams. J Pediatr. 2020 Apr;219:118-125.e5. doi: 10.1016/j.jpeds.2019.12.038. Epub 2020 Feb 6.
- Derived from this study: PubMed 30743197Medina-Alva P, Duque KR, Zea-Vera A, Bellomo S, Carcamo C, Guillen-Pinto D, Rivas M, Tori A, Zegarra J, Cam L, Castaneda A, Villavicencio A, Ochoa TJ. Combined predictors of neurodevelopment in very low birth weight preterm infants. Early Hum Dev. 2019 Mar;130:109-115. doi: 10.1016/j.earlhumdev.2019.01.019. Epub 2019 Feb 8.
- Derived from this study: PubMed 29613975Rueda MS, Calderon-Anyosa R, Gonzales J, Turin CG, Zea-Vera A, Zegarra J, Bellomo S, Cam L, Castaneda A, Ochoa TJ; NEOLACTO Research Group. Antibiotic Overuse in Premature Low Birth Weight Infants in a Developing Country. Pediatr Infect Dis J. 2019 Mar;38(3):302-307. doi: 10.1097/INF.0000000000002055.
- Derived from this study: PubMed 28125095Turin CG, Zea-Vera A, Rueda MS, Mercado E, Carcamo CP, Zegarra J, Bellomo S, Cam L, Castaneda A, Ochoa TJ; NEOLACTO Research Group. Lactoferrin concentration in breast milk of mothers of low-birth-weight newborns. J Perinatol. 2017 May;37(5):507-512. doi: 10.1038/jp.2016.265. Epub 2017 Jan 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa J Ochoa, MD principal investigator
Universidad Peruana Cayetano Heredia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bovine Lactoferrin and Maltodextrin in people with Late Onset Neonatal Sepsis, run by Universidad Peruana Cayetano Heredia at 3 sites in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First episode of late-onset sepsis or sepsis-associated death (time frame: 72hrs to 8 weeks of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01525316, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.