SepsisPhase 2NEOLACTONCT01264536
Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis
A Phase 2 study testing lactoferrin and Maltodextrin in people with Sepsis, run by Universidad Peruana Cayetano Heredia at 3 sites in Peru.
Trial summary
We will test the hypothesis that bovine lactoferrin supplementation prevents serious infections in preterm infants. We will conduct a randomized placebo-controlled double blind study in 190 premature infants <2500 gm in 5 Neonatal Intermediate and Intensive Care Units in Lima, Peru to determine whether bovine… Read more about this study
- Who is it for?
- Ages 24 to 72 hours
- Conditions the study is for
- Sepsis
- What is being tested?
- 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
- 190 participants
- Where
- 3 sitesPeru
- Study dates
- Dec 2010to Dec 2011
- Phase
- Phase 2
- 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 24 to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with a birth weight between 500g and 2500g
- 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 with a family background 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
Callao, Lima, Callao2
Hospital Guillermo Almnara Irigoyen
Lima, Lima Province, Lima13
Hospital Nacional Cayetano Heredia
Lima, Lima Province, Lima31
About this study
We will test the hypothesis that bovine lactoferrin supplementation prevents serious infections in preterm infants. We will conduct a randomized placebo-controlled double blind study in 190 premature infants <2500 gm in 5 Neonatal Intermediate and Intensive Care Units in Lima, Peru to determine whether bovine lactoferrin prevents the first episode of late-onset sepsis.
Read the detailed description
Lactoferrin is an iron chelating protein with multiple physiological functions (anti-microbial, anti-inflammatory and immunomodulatory) and is one of the most important proteins present in mammalian milk. We hypothesize that lactoferrin as an oral supplement given daily to low birth weight will improve their health by mimicking their protective role in milk. There is extensive literature showing in vitro and in animal models the benefits of lactoferrin. However, there are few clinical trials designed to translate this knowledge into patient care.
We will conduct a pilot randomized, double-blinded placebo-controlled trial comparing daily supplementation with bovine lactoferrin versus placebo in neonates to reduce the incidence of sepsis in the first month of life. We will enroll 190 neonates with a birth weight less than 2,500 g, younger than 3 days of age in the neonatal intensive care unit of 5 pediatric hospitals in Lima, after informed consent of both parents. Infants will be followed in the hospital until death or discharge and then at home up to 1 month of age. Bovine lactoferrin will be used in this trial (200 mg/Kg per day). Although bovine and human lactoferrin are not identical, their bioactivity is quite comparable. Maltodextrin (an inert sugar) will be used for controls. The primary study outcome will be the number of first late-onset sepsis episodes (occurring >72h after birth with isolation of any pathogen in blood or cerebrospinal fluid).
- Conditions
- Sepsis
- Being tested
- lactoferrin, Maltodextrin
- Keywords
- lactoferrin, sepsis, neonates, prevention, infections
- Medical subject headings
- Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactoferrinDietary supplement
Also called Bovine lactoferrin
Infants will receive oral bovine lactoferrin (200 mg/Kg/day divided in three dosis) for 4 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 4 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 |
|---|---|---|
| Lactoferrin | Experimental | Lactoferrin is a freeze-dried protein purified directly from fresh bovine milk. Receives: Dietary Supplement: 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.
Number of confirmed episodes of late-onset sepsis.
Number of confirmed episodes of late-onset sepsis in the first month of life
Measured: 1 month
Secondary outcomes (1)
Incidence of Gram positive and Gram negative bacterial and fungal bouts of sepsis, pneumonia, diarrhea and mortality
Incidence of Gram positive and Gram negative bacterial and fungal bouts of sepsis, pneumonia, diarrhea and mortality in the first month of life.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Ochoa, Universidad Peruana Cayetano Heredia
- Investigators
- Theresa J Ochoa, MD, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264536
- Sponsor's protocol ID
- SIDISI 56909
- Other IDs
- OPP1015669
- Acronym
- NEOLACTO
- Status last verified
- Sep 2012
- First submitted
- 20 Dec 2010
- Last updated
- 10 Sep 2012
- 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 25973934
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT01264536
- Acronym / sponsor ID
- NEOLACTO / SIDISI 56909
- Conditions
- Sepsis
- Keywords
- lactoferrin, sepsis, neonates, prevention, infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Dec 2010 (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.
We will test the hypothesis that bovine lactoferrin supplementation prevents serious infections in preterm infants. We will conduct a randomized placebo-controlled double blind study in 190 premature infants <2500 gm in 5 Neonatal Intermediate and Intensive Care Units in Lima, Peru to determine whether bovine lactoferrin prevents the first episode of late-onset sepsis.
Detailed description
Lactoferrin is an iron chelating protein with multiple physiological functions (anti-microbial, anti-inflammatory and immunomodulatory) and is one of the most important proteins present in mammalian milk. We hypothesize that lactoferrin as an oral supplement given daily to low birth weight will improve their health by mimicking their protective role in milk. There is extensive literature showing in vitro and in animal models the benefits of lactoferrin. However, there are few clinical trials designed to translate this knowledge into patient care.
We will conduct a pilot randomized, double-blinded placebo-controlled trial comparing daily supplementation with bovine lactoferrin versus placebo in neonates to reduce the incidence of sepsis in the first month of life. We will enroll 190 neonates with a birth weight less than 2,500 g, younger than 3 days of age in the neonatal intensive care unit of 5 pediatric hospitals in Lima, after informed consent of both parents. Infants will be followed in the hospital until death or discharge and then at home up to 1 month of age. Bovine lactoferrin will be used in this trial (200 mg/Kg per day). Although bovine and human lactoferrin are not identical, their bioactivity is quite comparable. Maltodextrin (an inert sugar) will be used for controls. The primary study outcome will be the number of first late-onset sepsis episodes (occurring >72h after birth with isolation of any pathogen in blood or cerebrospinal fluid).
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 |
|---|---|---|
| Lactoferrin | Experimental | Dietary Supplement: 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
- 24 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 2500g
- 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 with a family background 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 |
|---|---|---|
| lactoferrinAlso: Bovine lactoferrinInfants will receive oral bovine lactoferrin (200 mg/Kg/day divided in three dosis) for 4 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 | Lactoferrin |
| MaltodextrinInfants will receive oral maltodextrin (200mg/Kg/day in three divided dosis) for 4 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
Number of confirmed episodes of late-onset sepsis.
Time frame: 1 month
Number of confirmed episodes of late-onset sepsis in the first month of life
1 secondary outcome
Incidence of Gram positive and Gram negative bacterial and fungal bouts of sepsis, pneumonia, diarrhea and mortality
Time frame: 1 month
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 10 Sep 2012.
- 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.
- Derived from this study: 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.
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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 2 study testing lactoferrin and Maltodextrin in people with 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 10 Sep 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of confirmed episodes of late-onset sepsis. (time frame: 1 month). 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 NCT01264536, which also lists 2 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 10 Sep 2012.