Neonatal SepsisEarly Phase 1NCT01821989
Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate
A Early Phase 1 study testing Lactoferrin in people with Neonatal Sepsis, run by Mooselmokadem at 1 site in Egypt.
Trial summary
Hypothesis: Orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- Lactoferrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2013to Jan 2016
- 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 Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates with a birth weight between 500g and 2500g.
- Neonates with a ≤ 36 weeks of gestation counting from the first day of the Last Menstrual Period.
- Preterm neonates born in, or referred to the Neonatal Intensive Care Units of one of the participating hospitals in the first 48 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 who will not have the chance to complete the study time (who will be referred to another hospitals).
- Neonates whose parents decline to participate.
- Neonates with early onset sepsis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate.
Hypothesis:
Orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants.
Read more
The aim of the study is to:
- Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.
- Compare two dose regiment of lactoferrin supplementation.
- Study effect of lactoferrin supplementation on serum iron stores.
It is a prospective, randomized, double blind, placebo-controlled study, it will include 180 preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University Hospitals and Manshiet El Bakry Hospital.
•Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day.
•Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice daily.
•Group C (Controls): Who match the subjected neonates, will receive placebo in form of distilled water.
- Conditions
- Neonatal Sepsis
- Being tested
- Lactoferrin, Placebo
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDietary supplement
dose of 100 mg/day
LactoferrinDietary supplement
dose of 150 mg/kg/ twice daily
PlaceboDietary supplement
in form of distilled water
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Active comparator | Lactoferrin,dose of 100 mg/day. Receives: Dietary Supplement: Lactoferrin |
| High Dose | Experimental | Lactoferrin, dose of 150 mg/kg/ twice daily. Receives: Dietary Supplement: Lactoferrin |
| Control | Placebo comparator | Receive placebo in form of distilled water. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood culture
Measured: 2 years
Secondary outcomes (1)
Complete blood count with differential leucocytic count.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2016 (estimated)
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.
- 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mooselmokadem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa El-Mokadem, Mooselmokadem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821989
- Sponsor's protocol ID
- moos80
- Status last verified
- May 2014
- First submitted
- 27 Mar 2013
- Last updated
- 12 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate.
- ClinicalTrials.gov ID
- NCT01821989
- Acronym / sponsor ID
- moos80
- Conditions
- Neonatal Sepsis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- MooselmokademUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2016 (estimated)
- First posted
- 1 Apr 2013 (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.
Hypothesis:
Orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants.
The aim of the study is to:
- Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.
- Compare two dose regiment of lactoferrin supplementation.
- Study effect of lactoferrin supplementation on serum iron stores.
It is a prospective, randomized, double blind, placebo-controlled study, it will include 180 preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University Hospitals and Manshiet El Bakry Hospital.
•Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day.
•Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice daily.
•Group C (Controls): Who match the subjected neonates, will receive placebo in form of distilled water.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Active comparator | Dietary Supplement: LactoferrinLactoferrin,dose of 100 mg/day. |
| High Dose | Experimental | Dietary Supplement: LactoferrinLactoferrin, dose of 150 mg/kg/ twice daily. |
| Control | Placebo comparator | Dietary Supplement: PlaceboReceive placebo in form of distilled water. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates with a birth weight between 500g and 2500g.
- Neonates with a ≤ 36 weeks of gestation counting from the first day of the Last Menstrual Period.
- Preterm neonates born in, or referred to the Neonatal Intensive Care Units of one of the participating hospitals in the first 48 hours of life.
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 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 |
|---|---|---|
| Lactoferrindose of 100 mg/day | Dietary supplement | Low Dose |
| Lactoferrindose of 150 mg/kg/ twice daily | Dietary supplement | High Dose |
| Placeboin form of distilled water | Dietary supplement | Control |
Primary outcome
Blood culture
Time frame: 2 years
1 secondary outcome
Complete blood count with differential leucocytic count.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
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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.
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 Mooselmokadem 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 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: status not confirmed, as of the sponsor's last update on 12 May 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa AM Elmokadem, Master (01110857100 ext. 02, drmooselmokadem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood culture (time frame: 2 years). 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 12 May 2014.