Neonatal DiseaseNCT06015828
Effect of Enteral Bovine Lactoferrin in Preterm Infants
A study testing bovine lactoferrin in people with Neonatal Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
There is a preference for using enteral bovine lactoferrin for preterm infants. Lactoferrin is a sialic acid-rich, iron-binding milk glycoprotein, known to have multifunctional health benefits, including its ability to modulate immune function and facilitate iron absorption, as well as its antibacterial and anti… Read more about this study
- Who is it for?
- Ages 1 hour to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Disease
- What is being tested?
- bovine lactoferrin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2021to 20 Apr 2023
- 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 1 hour to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Stable preterm neonates
- gestational age less than 35 weeks
- younger than 72 hours at randomization
- have initiated enteral feds.
Who cannot join
- 1. Neonates with underlying gastrointestinal problems that prevent oral intake. 2. Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities,
- structural brain anomalies,
- severe congenital abnormalities). 3. Neonates with a history of perinatal hypoxia. 4. Neonates with a family background of cow milk allergy. 5. Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Enteral Bovine Lactoferrin on Neurobehavioral Performance of Preterm Infants
There is a preference for using enteral bovine lactoferrin for preterm infants. Lactoferrin is a sialic acid-rich, iron-binding milk glycoprotein, known to have multifunctional health benefits, including its ability to modulate immune function and facilitate iron absorption, as well as its antibacterial and anti inflammatory actions.
The study is an evaluation of the efficacy of enteral bovine lactoferrin on neurobehavioral performance in preterm infants.
Read the detailed description
Over 15 million infants are born preterm < 37 weeks gestation worldwide. Lactoferrin is about 80- kilo dalton kDa glycoprotein composed of 703 amino acid residues and is a member of the transferrin family, As a member of the transferrin family of iron-binding proteins, lactoferrin shares more than 60% homology at the amino acid level with transferrin and a 77% homology exists between human and bovine species.
Human lactoferrin is the most abundant glycoprotein. It contains 1- 4 Sialic acid residues at the terminal position of N-linked glycan chains for each lactoferrin molecule.
Poly Sialic acid plays a critical role in neural development by modulating the adhesive property of neural cell adhesion molecule and is, therefore, implicated in a wide range of morphogenic events, including cell migration, neuronal outgrowth, path-finding, sprouting, regeneration, synaptic plasticity, and serving a "reservoir function" for neurotrophic factors. Sia, a key monomeric building block of poly Sialic acid, plays crucial roles in cell-to-cell interactions, neuronal outgrowth, modifying synaptic connectivity, and memory formation An important functional property of lactoferrin is its high affinity for binding iron Iron is a ubiquitous metal that is essential for the function of all mammalian cells. Iron deficiency affects neuronal metabolism, neurotransmitter function, and myelination, which have the greatest impact on the brain during early neurodevelopment Lactoferrin is unique in that it contains 2 nutritional molecules of iron and Sialic acid, which are key components involved in early neurodevelopmental and cognitive function for infants Lactoferrin is a bifidogenic glycoprotein found in all vertebrates and mammalian milk, leukocytes, and exocrine secretions Inflammation has an adverse impact on cognition, and IL-1β, IL-6, and tumor necrosis factor alpha TNF-α are closely associated with long-term potentiation (LTP) and synaptic plasticity Lactoferrin is an antimicrobial, antioxidant, anti-inflammatory iron-carrying
- Conditions
- Neonatal Disease
- Being tested
- bovine lactoferrin
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bovine lactoferrinDietary supplement
Neonates will receive a daily dose of 150 mg/kg body weight per day (up to a maximum of 300 mg/day) of bovine lactoferrin and will be prepared for administration by addition by syringe of sterile water (4 mL) orally or through gavage feeding, once the infant's enteral feed volume is more than 12 mL/kg per day until 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.
| Study group | Role | What they receive |
|---|---|---|
| lactoferrin group | Experimental | Neonates will receive a daily dose of 150 mg/kg body weight per day (up to a maximum of 300 mg/day) of bovine lactoferrin and will be prepared for administration by addition by syringe of sterile water (4 mL) orally or through gavage feeding, once the infant's enteral feed volume is more than 12 mL/kg per day until 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer. (Asztalos.,et al 2020) Receives: Dietary Supplement: bovine lactoferrin |
| control group | No intervention | Neonates will receive their routine feds and will not receive lactoferrin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurobehavioral outcome
The present study is designed to evaluate the effect of oral administration of bovine lactoferrin on the neurobehavioral performance of preterm neonates at 36 weeks corrected age using the Neonatal Intensive Care Unit Neurobehavioral Scale (NNNS). ( minimum 0 , maximum 3 in each category)
Measured: at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.
Morbidity
Define any morbidities from oral lactoferrn administration
Measured: At 36 weeks corrected gestational age
Mortality
To assess number of deaths in the study group
Measured: 36 corrected gestational age
Secondary outcomes (1)
effect on morbidity and mortality
effect on mortality and major morbidity at 36 weeks corrected gestational age defined as periventricular leukomalacia, necrotizing enterocolitis, and late-onset sepsis.
Measured: at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start20 Sep 2021
- Primary completion20 Sep 2022
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiseaseStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Ibrahim, Ain Shams University
- Investigators
- maha mohamed, PHD, Study director, Ain Shams Universitydina shinkar, PHD, Study director, Ain Shams Universitymariam ibrahim, PHD, Study director, Ain Shams Universitymahmoud kofory, MB.,B.CH, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015828
- Sponsor's protocol ID
- AinShamsUlactoferrin
- Status last verified
- May 2024
- First submitted
- 16 Jul 2023
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enteral Bovine Lactoferrin on Neurobehavioral Performance of Preterm Infants
- ClinicalTrials.gov ID
- NCT06015828
- Acronym / sponsor ID
- AinShamsUlactoferrin
- Conditions
- Neonatal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 29 Aug 2023 (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.
There is a preference for using enteral bovine lactoferrin for preterm infants. Lactoferrin is a sialic acid-rich, iron-binding milk glycoprotein, known to have multifunctional health benefits, including its ability to modulate immune function and facilitate iron absorption, as well as its antibacterial and anti inflammatory actions.
The study is an evaluation of the efficacy of enteral bovine lactoferrin on neurobehavioral performance in preterm infants.
Detailed description
Over 15 million infants are born preterm < 37 weeks gestation worldwide. Lactoferrin is about 80- kilo dalton kDa glycoprotein composed of 703 amino acid residues and is a member of the transferrin family, As a member of the transferrin family of iron-binding proteins, lactoferrin shares more than 60% homology at the amino acid level with transferrin and a 77% homology exists between human and bovine species.
Human lactoferrin is the most abundant glycoprotein. It contains 1- 4 Sialic acid residues at the terminal position of N-linked glycan chains for each lactoferrin molecule.
Poly Sialic acid plays a critical role in neural development by modulating the adhesive property of neural cell adhesion molecule and is, therefore, implicated in a wide range of morphogenic events, including cell migration, neuronal outgrowth, path-finding, sprouting, regeneration, synaptic plasticity, and serving a "reservoir function" for neurotrophic factors. Sia, a key monomeric building block of poly Sialic acid, plays crucial roles in cell-to-cell interactions, neuronal outgrowth, modifying synaptic connectivity, and memory formation An important functional property of lactoferrin is its high affinity for binding iron Iron is a ubiquitous metal that is essential for the function of all mammalian cells. Iron deficiency affects neuronal metabolism, neurotransmitter function, and myelination, which have the greatest impact on the brain during early neurodevelopment Lactoferrin is unique in that it contains 2 nutritional molecules of iron and Sialic acid, which are key components involved in early neurodevelopmental and cognitive function for infants Lactoferrin is a bifidogenic glycoprotein found in all vertebrates and mammalian milk, leukocytes, and exocrine secretions Inflammation has an adverse impact on cognition, and IL-1β, IL-6, and tumor necrosis factor alpha TNF-α are closely associated with long-term potentiation (LTP) and synaptic plasticity Lactoferrin is an antimicrobial, antioxidant, anti-inflammatory iron-carrying
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lactoferrin group | Experimental | Dietary Supplement: bovine lactoferrinNeonates will receive a daily dose of 150 mg/kg body weight per day (up to a maximum of 300 mg/day) of bovine lactoferrin and will be prepared for administration by addition by syringe of sterile water (4 mL) orally or through gavage feeding, once the infant's enteral feed volume is more than 12 mL/kg per day until 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer. (Asztalos.,et al 2020) |
| control group | No intervention | –Neonates will receive their routine feds and will not receive lactoferrin. |
Who may qualify
- Ages
- 1 hour to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Stable preterm neonates
- gestational age less than 35 weeks
- younger than 72 hours at randomization
- have initiated enteral feds.
Key exclusion criteria (3 listed)
- 1. Neonates with underlying gastrointestinal problems that prevent oral intake. 2. Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities,
- structural brain anomalies,
- severe congenital abnormalities). 3. Neonates with a history of perinatal hypoxia. 4. Neonates with a family background of cow milk allergy. 5. Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake.
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 |
|---|---|---|
| bovine lactoferrinNeonates will receive a daily dose of 150 mg/kg body weight per day (up to a maximum of 300 mg/day) of bovine lactoferrin and will be prepared for administration by addition by syringe of sterile water (4 mL) orally or through gavage feeding, once the infant's enteral feed volume is more than 12 mL/kg per day until 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer. | Dietary supplement | lactoferrin group |
Primary outcome
neurobehavioral outcome
Time frame: at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.
The present study is designed to evaluate the effect of oral administration of bovine lactoferrin on the neurobehavioral performance of preterm neonates at 36 weeks corrected age using the Neonatal Intensive Care Unit Neurobehavioral Scale (NNNS). ( minimum 0 , maximum 3 in each category)
Morbidity
Time frame: At 36 weeks corrected gestational age
Define any morbidities from oral lactoferrn administration
Mortality
Time frame: 36 corrected gestational age
To assess number of deaths in the study group
1 secondary outcome
effect on morbidity and mortality
Time frame: at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.
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 16 May 2024.
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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.
maha mohamed, PHD study director
Ain Shams University
dina shinkar, PHD study director
Ain Shams University
mariam ibrahim, PHD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bovine lactoferrin in people with Neonatal Disease, run by Ain Shams 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 4 inclusion and 3 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 16 May 2024. 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. 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?
neurobehavioral outcome (time frame: at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.). 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 16 May 2024.