Neonatal SepsisPhase 4NCT02959229
Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis
A Phase 4 study testing Lactoferrin in people with Neonatal Sepsis, run by Ain Shams University.
Trial summary
The present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration on serum Ferritin and follow up long term outcome… Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- Lactoferrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Oct 2016
- Phase
- Phase 4
- 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 Up to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates with a < 37 weeks of gestation counting from the first day of the Last Menstrual Period.
- Preterm neonates are breast fed, artificially fed or on total parenteral nutrition.
- Preterm neonates born in, or referred to our Neonatal Intensive Care Unit in the first day of life free from infection and not fed.
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 who will not have the chance to complete the study time (who will be referred to another hospitals).
- Neonates with early onset sepsis.
- Neonates whose parents decline to participate.
About this study
Official title: Systematic Randomized , Single Blinded, Placebo-Controlled Trial of Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis
The present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis.
Read the detailed description
This study was carried out on 180 preterm neonates(< 37 weeks of gestation counting from the first day of the Last Menstrual Period and confirmed by Ballard score) admitted to the Neonatal Intensive Care Units of Ain Shams University Hospitals in the period from August 2014 to December 2015.
Enrolled subjects were further randomly subdivided into three groups according to the dose regimen of Lactoferrin supplementation.
- Group A: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 1 and continue for 4-6 weeks.
- Group B: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 3 (48hrs-72hrs) of life and continue for 4-6 weeks.
- Group C: (60 preterm neonates) who match the subjected neonates, received placebo in form of distilled water.
- Conditions
- Neonatal Sepsis
- Being tested
- Lactoferrin, Placebo (for Lactoferrin)
- Keywords
- Late onset sepsis, Bovine Lactoferrin
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDrug
Also called Bovine Lactoferrin
Placebo (for Lactoferrin)Drug
placebo in form of distilled water
| Study group | Role | What they receive |
|---|---|---|
| Early Lactoferrin Group | Experimental | Oral Bovine Lactoferrin 100 mg/day once starting on day 1 of life and continued for 4-6 weeks. Receives: Drug: Lactoferrin |
| Late Lactoferrin Group | Experimental | Oral Bovine Lactoferrin 100 mg/day once starting on day 3 of life and continued for 4-6 weeks. Receives: Drug: Lactoferrin |
| Placebo Group | Active comparator | placebo in form of distilled water once starting on day 1 of life and continued for 4-6 weeks. Receives: Drug: Placebo (for Lactoferrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of oral Lactoferrin in prevention of neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture.
Measured: 4-6 weeks of life
Compare early (1st day) versus late (48-72 hours) Lactoferrin administration on neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture
Measured: 4-6 weeks of life
Secondary outcomes (2)
Effect of Lactoferrin supplementation on long term complications
Long term complications as:
Broncho-Pulmonary Dysplasia using clinical symptoms and signs and chest X ray findings.
Retinopathy of Prematurity using the International Classification of Retinopathy of Prematurity (ICROP).
Necrotizing Enterocolitis using Modified Bell's criteria for staging Necrotizing Enterocolitis.
Measured: 4-6 weeks of life
any reported side effects for Bovine Lactoferrin
Measured: 4-6 weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionOct 2016
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 Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Nagy Mohamed, Ain Shams University
- Investigators
- Ghada I Ghad, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959229
- Sponsor's protocol ID
- FMASU M.S 23/2016
- Status last verified
- Nov 2016
- First submitted
- 27 Oct 2016
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kaur G, Gathwala G. Efficacy of Bovine Lactoferrin Supplementation in Preventing Late-onset Sepsis in low Birth Weight Neonates: A Randomized Placebo-Controlled Clinical Trial. J Trop Pediatr. 2015 Oct;61(5):370-6. doi: 10.1093/tropej/fmv044. Epub 2015 Jul 29.
PubMed 26224129Manzoni P, Meyer M, Stolfi I, Rinaldi M, Cattani S, Pugni L, Romeo MG, Messner H, Decembrino L, Laforgia N, Vagnarelli F, Memo L, Bordignon L, Maule M, Gallo E, Mostert M, Quercia M, Bollani L, Pedicino R, Renzullo L, Betta P, Ferrari F, Alexander T, Magaldi R, Farina D, Mosca F, Stronati M. Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: a randomized clinical trial. Early Hum Dev. 2014 Mar;90 Suppl 1:S60-5. doi: 10.1016/S0378-3782(14)70020-9.
PubMed 24709463
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Randomized , Single Blinded, Placebo-Controlled Trial of Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT02959229
- Acronym / sponsor ID
- FMASU M.S 23/2016
- Conditions
- Neonatal Sepsis
- Keywords
- Late onset sepsis, Bovine Lactoferrin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Nov 2016 (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 present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis.
Detailed description
This study was carried out on 180 preterm neonates(< 37 weeks of gestation counting from the first day of the Last Menstrual Period and confirmed by Ballard score) admitted to the Neonatal Intensive Care Units of Ain Shams University Hospitals in the period from August 2014 to December 2015.
Enrolled subjects were further randomly subdivided into three groups according to the dose regimen of Lactoferrin supplementation.
- Group A: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 1 and continue for 4-6 weeks.
- Group B: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 3 (48hrs-72hrs) of life and continue for 4-6 weeks.
- Group C: (60 preterm neonates) who match the subjected neonates, received placebo in form of distilled water.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Lactoferrin Group | Experimental | Drug: LactoferrinOral Bovine Lactoferrin 100 mg/day once starting on day 1 of life and continued for 4-6 weeks. |
| Late Lactoferrin Group | Experimental | Drug: LactoferrinOral Bovine Lactoferrin 100 mg/day once starting on day 3 of life and continued for 4-6 weeks. |
| Placebo Group | Active comparator | Drug: Placebo (for Lactoferrin)placebo in form of distilled water once starting on day 1 of life and continued for 4-6 weeks. |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates with a < 37 weeks of gestation counting from the first day of the Last Menstrual Period.
- Preterm neonates are breast fed, artificially fed or on total parenteral nutrition.
- Preterm neonates born in, or referred to our Neonatal Intensive Care Unit in the first day of life free from infection and not fed.
Key exclusion criteria (6 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 who will not have the chance to complete the study time (who will be referred to another hospitals).
- Neonates with early onset sepsis.
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 Lactoferrin | Drug | Early Lactoferrin Group, Late Lactoferrin Group |
| Placebo (for Lactoferrin)placebo in form of distilled water | Drug | Placebo Group |
Primary outcome
Evaluate the effectiveness of oral Lactoferrin in prevention of neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture.
Time frame: 4-6 weeks of life
Compare early (1st day) versus late (48-72 hours) Lactoferrin administration on neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture
Time frame: 4-6 weeks of life
2 secondary outcomes
Effect of Lactoferrin supplementation on long term complications
Time frame: 4-6 weeks of life
any reported side effects for Bovine Lactoferrin
Time frame: 4-6 weeks of life
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 9 Nov 2016.
- Background: PubMed 26224129Kaur G, Gathwala G. Efficacy of Bovine Lactoferrin Supplementation in Preventing Late-onset Sepsis in low Birth Weight Neonates: A Randomized Placebo-Controlled Clinical Trial. J Trop Pediatr. 2015 Oct;61(5):370-6. doi: 10.1093/tropej/fmv044. Epub 2015 Jul 29.
- Background: PubMed 24709463Manzoni P, Meyer M, Stolfi I, Rinaldi M, Cattani S, Pugni L, Romeo MG, Messner H, Decembrino L, Laforgia N, Vagnarelli F, Memo L, Bordignon L, Maule M, Gallo E, Mostert M, Quercia M, Bollani L, Pedicino R, Renzullo L, Betta P, Ferrari F, Alexander T, Magaldi R, Farina D, Mosca F, Stronati M. Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: a randomized clinical trial. Early Hum Dev. 2014 Mar;90 Suppl 1:S60-5. doi: 10.1016/S0378-3782(14)70020-9.
- Individual participant dataSharing planned: Undecided
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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.
Ghada I Ghad, Professor study director
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactoferrin in people with Neonatal Sepsis, run by Ain Shams University.
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 3 inclusion and 6 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 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluate the effectiveness of oral Lactoferrin in prevention of neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture. (time frame: 4-6 weeks of life). The study lists 2 primary outcomes in all. 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 NCT02959229, 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 9 Nov 2016.