Feeding; Difficult, NewbornNCT06336668
Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation
A study testing Human milk-based HMF in people with Feeding; Difficult, Newborn, run by University of Calgary.
Trial summary
Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. Read more about this study
- Who is it for?
- Ages Up to 30 weeks
- Conditions the study is for
- Feeding; Difficult, Newborn
- What is being tested?
- Human milk-based HMF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 28 Feb 2026
- 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 Up to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born <30 weeks' gestation age and less than 1500g of weight.
- Admitted in Neonatal Intensive Care Unit at Foothills Medical Center
- Reached full fortified enteral feed and at least 21 days of chronological age.
Who cannot join
- Chromosomal or major congenital anomalies
- Infants diagnosed with NEC.
Trial locations and contacts
No sites are listed yet.
Basel Thayyil contact
About this study
Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives.
The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks.
Read the detailed description
The fortification of human milk has been proven to enhance growth without raising the risk of necrotizing enterocolitis, although it may affect feeding tolerance.
Non-invasive techniques like Doppler ultrasonography of the superior mesenteric artery (SMA) and near-infrared spectroscopy (NIRS) have been utilized to evaluate mesenteric blood flow and intestinal oxygenation in preterm infants. Numerous studies have investigated the relationship between SMA flow and feeding intolerance. Findings indicate a significant correlation between increased mean Superior Mesenteric Artery blood flow velocity and early tolerance of enteral feeding. Moreover, research suggests a higher incidence of necrotizing enterocolitis (NEC) in preterm infants exhibiting increased resistance patterns of SMA blood flow velocity on the first day.
Non-invasive monitoring methods offer the ability to assess the impact of various fortification products on intestinal perfusion and oxygenation. This could aid in determining the most suitable fortification product to minimize episodes of feeding intolerance.
- Conditions
- Feeding; Difficult, Newborn
- Being tested
- Human milk-based HMF
- Keywords
- Feed intolerance, Human Milk fortifier, Bovine based Human Milk Fortifier, Human milk based Human Milk Fortifier, Preterm infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human milk-based HMFDietary supplement
The study subject will be fed human milk fortified with a human-milk-based HMF.
| Study group | Role | What they receive |
|---|---|---|
| Bovine based-HMF | Active comparator | The infant will fed human milk fortified with bovine-based HMF. Receives: Dietary Supplement: Human milk-based HMF |
| Human milk-based HMF | Experimental | The infant will be fed human milk fortified with human milk-based HMF. Receives: Dietary Supplement: Human milk-based HMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy
Measurements of Near Infrared Spectroscopy are continuous but readings of interest are: before feeding, 30 and 120 minutes after finishing feed.
Measured: 6 hours
Secondary outcomes (3)
Changes in SMA doppler peak flow velocity (PSV)
SMA doppler will be performed before feed, and 30 and 120 minutes after completing the feed.
Measured: 6 hours
Changes in SMA doppler end-diastolic velocity (EDV)
SMA doppler will be performed before feed, and 30 and 120 minutes after completing the feed.
Measured: 6 hours
Changes in SMA doppler Porcelout's resistance index (RI)
SMA doppler will be performed before feed, and 30 and 120 minutes after completing the feed.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Jun 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding; Difficult, NewbornStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective randomized-controlled crossover trial comparing 2 different HMFs and 2 intestinal rSO2S periods in random order: 6 hours while on B-HMF and 6 hours on H-HMF with at least 6 hours washing period
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belal Alshaikh, University of Calgary
- Investigators
- Belal Alshaikh, MD, MSCE, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336668
- Sponsor's protocol ID
- REB23-1283
- Status last verified
- May 2024
- First submitted
- 21 Mar 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation
- ClinicalTrials.gov ID
- NCT06336668
- Acronym / sponsor ID
- REB23-1283
- Conditions
- Feeding; Difficult, Newborn
- Keywords
- Feed intolerance, Human Milk fortifier, Bovine based Human Milk Fortifier, Human milk based Human Milk Fortifier, Preterm infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 29 Mar 2024 (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.
Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives.
The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks.
Detailed description
The fortification of human milk has been proven to enhance growth without raising the risk of necrotizing enterocolitis, although it may affect feeding tolerance.
Non-invasive techniques like Doppler ultrasonography of the superior mesenteric artery (SMA) and near-infrared spectroscopy (NIRS) have been utilized to evaluate mesenteric blood flow and intestinal oxygenation in preterm infants. Numerous studies have investigated the relationship between SMA flow and feeding intolerance. Findings indicate a significant correlation between increased mean Superior Mesenteric Artery blood flow velocity and early tolerance of enteral feeding. Moreover, research suggests a higher incidence of necrotizing enterocolitis (NEC) in preterm infants exhibiting increased resistance patterns of SMA blood flow velocity on the first day.
Non-invasive monitoring methods offer the ability to assess the impact of various fortification products on intestinal perfusion and oxygenation. This could aid in determining the most suitable fortification product to minimize episodes of feeding intolerance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective randomized-controlled crossover trial comparing 2 different HMFs and 2 intestinal rSO2S periods in random order: 6 hours while on B-HMF and 6 hours on H-HMF with at least 6 hours washing period
| Arm | Type | Receives |
|---|---|---|
| Bovine based-HMF | Active comparator | Dietary Supplement: Human milk-based HMFThe infant will fed human milk fortified with bovine-based HMF. |
| Human milk-based HMF | Experimental | Dietary Supplement: Human milk-based HMFThe infant will be fed human milk fortified with human milk-based HMF. |
Who may qualify
- Ages
- Up to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants born <30 weeks' gestation age and less than 1500g of weight.
- Admitted in Neonatal Intensive Care Unit at Foothills Medical Center
- Reached full fortified enteral feed and at least 21 days of chronological age.
Key exclusion criteria (2 listed)
- Chromosomal or major congenital anomalies
- Infants diagnosed with NEC.
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 |
|---|---|---|
| Human milk-based HMFThe study subject will be fed human milk fortified with a human-milk-based HMF. | Dietary supplement | Bovine based-HMF, Human milk-based HMF |
Primary outcome
Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy
Time frame: 6 hours
Measurements of Near Infrared Spectroscopy are continuous but readings of interest are: before feeding, 30 and 120 minutes after finishing feed.
3 secondary outcomes
Changes in SMA doppler peak flow velocity (PSV)
Time frame: 6 hours
Changes in SMA doppler end-diastolic velocity (EDV)
Time frame: 6 hours
Changes in SMA doppler Porcelout's resistance index (RI)
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Basel Thayyil contact
Belal Alshaikh, MD, MSCE principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Human milk-based HMF in people with Feeding; Difficult, Newborn, run by University of Calgary.
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 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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.
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 Belal AlShaikh, MD, MSCE ((403) 956 1588, balshaik@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy (time frame: 6 hours). 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 8 May 2024.