Late Onset Neonatal SepsisNCT01287507
Lactoferrin Prophylaxis in VLBW and Regulator T-cells
A study testing Lactoferrin (bovine origin) in people with Late Onset Neonatal Sepsis and Necrotising Enterocolitis, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells. Read more about this study
- Who is it for?
- Ages 15 minutes to 1 day
- Conditions the study is for
- Late Onset Neonatal Sepsis, Necrotising Enterocolitis, Very Low Birth Weight Infants
- What is being tested?
- Lactoferrin (bovine origin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2009to Dec 2011
- Phase
- Interventional
- 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 15 minutes to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn infants
- Gestational age < 32 weeks
- Birth weight < 1500 g
- Parental consent
Who cannot join
- Congenital abnormalities
- Severe perinatal asphyxia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School of Medicine Department of Pediatrics, NICU
Ankara, 06500
About this study
Official title: Oral Lactoferrin Prophylaxis to Prevent Sepsis and Necrotising Enterocolitis of Very Low Birth Weight Neonates in Neonatal Intensive Care Unit and Effect on T-regulatory Cells.
The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells.
- Being tested
- Lactoferrin (bovine origin)
- Keywords
- VLBW, NEC, Late onset sepsis
- Medical subject headings
- Neonatal Sepsis, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin (bovine origin)Dietary supplement
Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | In born VLBW infants with parental consent form signed will be given oral saline daily as placebo until discharge Receives: Dietary Supplement: Lactoferrin (bovine origin) |
| Lactoferrin | Experimental | In born VLBW infants with parental consent form signed will be given oral bovine lactoferrin daily until discharge Receives: Dietary Supplement: Lactoferrin (bovine origin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
late onset sepsis
The effect of oral Lactoferrin prophylaxis on the number of culture proven sepsis attacks in very low birth weight infants during their hospitalization in neonatal intensive care unit. Sterile blood, urine and cerebrospinal fluid samples will be obtained in case of clinical symptoms of sepsis for culture.
Measured: from birth to discharge from NICU
Necrotising enterocolitis
The effect of oral Lactoferrin prophylaxis on severe necrotising enterocolitis (NEC) (Bell's stage 2 and 3) in very low birth infants during the hospitalization period in Neonatal intensive care unit. In case of feeding intolerance, abdominal distention and findings of ileus with clinical deterioration, patient will be evaluated for thrombocytopenia, metabolic acidosis, hyponatremia, blood in stool and radiological findings of NEC. Staging will be performed with clinical, laboratory and radiological findings.
Measured: from birth to discharge from NICU
Effect on T regulatory cells
FOXP3 expression on CD4+CD25+ T cells
Measured: at discharge
Secondary outcomes (2)
Safety of lactoferrin in VLBW infants
the effect oral lactoferrin use on feeding tolerance, abdominal distension, vomiting and gastric residuals
Measured: during the oral use of lactoferrin
duration of hospitalization
the effect of oral lactoferrin on the duration of hospitalization
Measured: from birth to discharge from neonatal intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Onset Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Ankara 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke Mungan Akin, Ankara University
- Investigators
- Saadet Arsan, Prof, Study chair, Anlara University Chief of Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287507
- Sponsor's protocol ID
- Lactoferrin
- Status last verified
- Aug 2014
- First submitted
- 31 Jan 2011
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Lactoferrin Prophylaxis to Prevent Sepsis and Necrotising Enterocolitis of Very Low Birth Weight Neonates in Neonatal Intensive Care Unit and Effect on T-regulatory Cells.
- ClinicalTrials.gov ID
- NCT01287507
- Acronym / sponsor ID
- Lactoferrin
- Keywords
- VLBW, NEC, Late onset sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Feb 2011 (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 aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Lactoferrin (bovine origin)In born VLBW infants with parental consent form signed will be given oral saline daily as placebo until discharge |
| Lactoferrin | Experimental | Dietary Supplement: Lactoferrin (bovine origin)In born VLBW infants with parental consent form signed will be given oral bovine lactoferrin daily until discharge |
Who may qualify
- Ages
- 15 minutes to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Inborn infants
- Gestational age < 32 weeks
- Birth weight < 1500 g
- Parental consent
Key exclusion criteria (2 listed)
- Congenital abnormalities
- Severe perinatal asphyxia
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 |
|---|---|---|
| Lactoferrin (bovine origin)Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula | Dietary supplement | Lactoferrin, Placebo |
Primary outcome
late onset sepsis
Time frame: from birth to discharge from NICU
The effect of oral Lactoferrin prophylaxis on the number of culture proven sepsis attacks in very low birth weight infants during their hospitalization in neonatal intensive care unit. Sterile blood, urine and cerebrospinal fluid samples will be obtained in case of clinical symptoms of sepsis for culture.
Necrotising enterocolitis
Time frame: from birth to discharge from NICU
The effect of oral Lactoferrin prophylaxis on severe necrotising enterocolitis (NEC) (Bell's stage 2 and 3) in very low birth infants during the hospitalization period in Neonatal intensive care unit. In case of feeding intolerance, abdominal distention and findings of ileus with clinical deterioration, patient will be evaluated for thrombocytopenia, metabolic acidosis, hyponatremia, blood in stool and radiological findings of NEC. Staging will be performed with clinical, laboratory and radiological findings.
Effect on T regulatory cells
Time frame: at discharge
FOXP3 expression on CD4+CD25+ T cells
2 secondary outcomes
Safety of lactoferrin in VLBW infants
Time frame: during the oral use of lactoferrin
duration of hospitalization
Time frame: from birth to discharge from neonatal intensive care unit
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 26 Aug 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.
Saadet Arsan, Prof study chair
Anlara University Chief of Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin (bovine origin) in people with Late Onset Neonatal Sepsis and Necrotising Enterocolitis, run by Ankara University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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 26 Aug 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 Turkey (Türkiye). 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.
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?
late onset sepsis (time frame: from birth to discharge from NICU). The study lists 3 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 26 Aug 2014.