Neonatal SEPSISEarly Phase 1LactoferrinNCT04094597
Safety and Efficacy of Oral Bovine Lactoferrin
A Early Phase 1 study testing Lactoferrin in people with Neonatal SEPSIS, run by Cairo University at 1 site in Egypt.
Trial summary
Oral lactoferrin versus Placebo will be given to preterm neonates Read more about this study
- Who is it for?
- Ages 1 day to 7 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
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 2 Mar 2019
- Phase
- Early Phase 1
- 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 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All neonates born at Cairo university hospital NICU
Who cannot join
- Neonatal deaths before 3 days postnatal .
- Neonates with underlying gastrointestinal problems that prevent oral intake.
- Neonates with major congenital anomalies .
- Neonates with severe hypoxic ischemic encephaloapathy .
- Neonates whose parents refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectivness and Safety of Oral Bovine Lactoferrin in Neonatal Sepsis and Necrotizing Enterocolitis and Its Effect on Anaemia of Prematurity
Oral lactoferrin versus Placebo will be given to preterm neonates
Read the detailed description
200 patient were included in the study , one hundred received oral placebo in the form of 2 ml saline , the other 100 preterm neonates received oral lactoferrin with monitoring of C-reactive protein , different cultures, complete blood count on day 7 and after one month.
- Conditions
- Neonatal SEPSIS
- Being tested
- Lactoferrin, Placebos
- Keywords
- 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 Pravotin sachets
lactoferrin is given orally in comparsion to placebp
PlacebosDrug
Also called saline
placebp is given in 2 ml saline
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | saline is given orally in dose of 2 ml per day for one month Receives: Drug: Placebos |
| lacoferrin | Active comparator | Pravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month Receives: Drug: Lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mortality rate of neonatal sepsis in preterm neonate
Neonates will be assessed by C-reactive protein and different cultures to identify Neonatal sepsis
Measured: one year
Number of Preterm Neonates who will have long term Complication after one month of regular use of Lactoferrin
Neonates will be assessed for long term complication as necrotizing enterocolitis , retinoapathy of prematurity and bronchopulmonary dysplasia
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Jan 2018
- Primary completion28 Dec 2018
- Study completion2 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SEPSISStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo group 100 patient will receive 2 ml saline for one month in comparison with oral lactoferrin for the same period to another 100 patient
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Principal investigator, ayman zaher, Cairo University
- Investigators
- ayman zaher, bachelor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094597
- Sponsor's protocol ID
- Abu Elrich children hospital
- Other IDs
- 01525316
- Acronym
- Lactoferrin
- Status last verified
- Sep 2019
- First submitted
- 4 Apr 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: lactoferrin improves the mortality rate of neonatal sepsis
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivness and Safety of Oral Bovine Lactoferrin in Neonatal Sepsis and Necrotizing Enterocolitis and Its Effect on Anaemia of Prematurity
- ClinicalTrials.gov ID
- NCT04094597
- Acronym / sponsor ID
- Lactoferrin / Abu Elrich children hospital
- Conditions
- Neonatal SEPSIS
- Keywords
- lactoferrin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 19 Sep 2019 (actual)
- 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.
Oral lactoferrin versus Placebo will be given to preterm neonates
Detailed description
200 patient were included in the study , one hundred received oral placebo in the form of 2 ml saline , the other 100 preterm neonates received oral lactoferrin with monitoring of C-reactive protein , different cultures, complete blood count on day 7 and after one month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- placebo group 100 patient will receive 2 ml saline for one month in comparison with oral lactoferrin for the same period to another 100 patient
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebossaline is given orally in dose of 2 ml per day for one month |
| lacoferrin | Active comparator | Drug: LactoferrinPravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All neonates born at Cairo university hospital NICU
Key exclusion criteria (5 listed)
- Neonatal deaths before 3 days postnatal .
- Neonates with underlying gastrointestinal problems that prevent oral intake.
- Neonates with major congenital anomalies .
- Neonates with severe hypoxic ischemic encephaloapathy .
- Neonates whose parents refuse 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: Pravotin sachetslactoferrin is given orally in comparsion to placebp | Drug | lacoferrin |
| PlacebosAlso: salineplacebp is given in 2 ml saline | Drug | placebo |
Primary outcome
Change in mortality rate of neonatal sepsis in preterm neonate
Time frame: one year
Neonates will be assessed by C-reactive protein and different cultures to identify Neonatal sepsis
Number of Preterm Neonates who will have long term Complication after one month of regular use of Lactoferrin
Time frame: one year
Neonates will be assessed for long term complication as necrotizing enterocolitis , retinoapathy of prematurity and bronchopulmonary dysplasia
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 19 Sep 2019.
- lactoferrinLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. lactoferrin improves the mortality rate of neonatal sepsis
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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.
ayman zaher, bachelor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lactoferrin in people with Neonatal SEPSIS, run by Cairo University at 1 site in Egypt.
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 1 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 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in mortality rate of neonatal sepsis in preterm neonate (time frame: one year). 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?
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 19 Sep 2019.