Postnatal Growth RestrictionNCT05228847
Human Milk-derived Fortification in Preterm Infants
A study testing Human milk-derived HMF and bovine milk-derived HMF in people with Postnatal Growth Restriction and Necrotizing Enterocolitis, run by University of Calgary at 1 site in Canada.
Trial summary
Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW) infants. Read more about this study
- Who is it for?
- Ages 3 days to 12 weeks
- Conditions the study is for
- Postnatal Growth Restriction, Necrotizing Enterocolitis
- What is being tested?
- Human milk-derived HMF and bovine milk-derived HMF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2023to 30 May 2025
- 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 3 days to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birthweight between 400 g-1250 g
- Less than or 32 weeks gestational age at birth
- Subject has been classified as appropriate for gestational age
- Enteral feeding of human milk is initiated by 72 hours
- Subject is expected to be on human milk for at least 3 weeks.
Who cannot join
- Congenital abnormalities or underlying disease that may affect growth
- Maternal cocaine, alcohol, or opioid abuse during pregnancy
- Mother or infant is currently receiving treatment for HIV infection
- Infant with major surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Human Milk-derived Fortifiers on Weight Gain in Preterm Infants <1250 g: A Randomized Controlled Trial
Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW) infants. Multi-nutrient human milk fortifiers (HMFs) are designed to meet the macro and micro-nutrient needs of VLBW infants. HMFs differ by the origin of milk and by nutrient composition. Traditionally, bovine milk has been the main source of multi-nutrient HMFs.
Read the detailed description
Recent advances in lacto-engineering techniques allowed the manufacturing of multi-nutrient HMF from human milk as an alternative to bovine milk. Since exposure to infant bovine-based formula feeds is frequently shown to increase neonatal morbidities, human milk-derived HMFs (H-HMFs) have been frequently proposed to minimize exposure to bovine products prior to 34 weeks gestation with an intent to decrease the risks of necrotizing enterocolitis and feeding intolerance. The use of multi-nutrient H-HMFs is a promising intervention however currently available H-HMFs are expensive.
The main objective of this randomized controlled trial is to compare the weight gain achieved by preterm infants born <1250 g and fed human milk fortified with H-HMFs (made from mother's own milk (MOM) when MOM supply exceeds the daily need of her preterm infant or from donor human milk (DHM) compared with counterparts fed human milk fortified with the currently used bovine-derived fortifier (B-HMF).
- Being tested
- Human milk-derived HMF, bovine milk-derived HMF
- Keywords
- Human milk
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human milk-derived HMFDietary supplement
Fortification with human milk-derived product
bovine milk-derived HMFDietary supplement
bovine milk-derived HMF
| Study group | Role | What they receive |
|---|---|---|
| Human milk-derived HMF | Active comparator | Fortification with human milk-derived product Receives: Dietary Supplement: Human milk-derived HMF |
| Bovine milk-derived HMF | Other | Current standard practice: Fortification with bovine milk-derived product Receives: Dietary Supplement: bovine milk-derived HMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average weight gain
Average weight gain measured as g/kg per day
Measured: up to 3 weeks
Secondary outcomes (5)
Head circumference
Measurement of head circumference in centimeters
Measured: Weekly for 8 weeks
Length
Measurement of length in centimeters
Measured: Weekly for 8 weeks
Feed intolerance
Incidence of interruption in enteral feeding due to feed intolerance (vomiting or abdominal distension), unrelated to a clinical procedure, that lasted for ≥12 hours or a >50% reduction in volume over the same time frame.
Measured: 3 weeks
Electrolytes abnormalities
Incidence of any abnormality in one of the following electrolytes: sodium, potassium, calcium and phosphorus
Measured: 3 weeks
Need for additional signal nutrient supplementation
Number of additions of single nutrient supplementation (include protein, fat and carbohydrate) in each group.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start15 Jan 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal Growth RestrictionStudies 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 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, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228847
- Sponsor's protocol ID
- REB22-039
- Status last verified
- Nov 2022
- First submitted
- 14 Jan 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Human Milk-derived Fortifiers on Weight Gain in Preterm Infants <1250 g: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05228847
- Acronym / sponsor ID
- REB22-039
- Keywords
- Human milk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 8 Feb 2022 (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.
Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW) infants. Multi-nutrient human milk fortifiers (HMFs) are designed to meet the macro and micro-nutrient needs of VLBW infants. HMFs differ by the origin of milk and by nutrient composition. Traditionally, bovine milk has been the main source of multi-nutrient HMFs.
Detailed description
Recent advances in lacto-engineering techniques allowed the manufacturing of multi-nutrient HMF from human milk as an alternative to bovine milk. Since exposure to infant bovine-based formula feeds is frequently shown to increase neonatal morbidities, human milk-derived HMFs (H-HMFs) have been frequently proposed to minimize exposure to bovine products prior to 34 weeks gestation with an intent to decrease the risks of necrotizing enterocolitis and feeding intolerance. The use of multi-nutrient H-HMFs is a promising intervention however currently available H-HMFs are expensive.
The main objective of this randomized controlled trial is to compare the weight gain achieved by preterm infants born <1250 g and fed human milk fortified with H-HMFs (made from mother's own milk (MOM) when MOM supply exceeds the daily need of her preterm infant or from donor human milk (DHM) compared with counterparts fed human milk fortified with the currently used bovine-derived fortifier (B-HMF).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human milk-derived HMF | Active comparator | Dietary Supplement: Human milk-derived HMFFortification with human milk-derived product |
| Bovine milk-derived HMF | Other | Dietary Supplement: bovine milk-derived HMFCurrent standard practice: Fortification with bovine milk-derived product |
Who may qualify
- Ages
- 3 days to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Birthweight between 400 g-1250 g
- Less than or 32 weeks gestational age at birth
- Subject has been classified as appropriate for gestational age
- Enteral feeding of human milk is initiated by 72 hours
- Subject is expected to be on human milk for at least 3 weeks.
Key exclusion criteria (4 listed)
- Congenital abnormalities or underlying disease that may affect growth
- Maternal cocaine, alcohol, or opioid abuse during pregnancy
- Mother or infant is currently receiving treatment for HIV infection
- Infant with major surgery
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-derived HMFFortification with human milk-derived product | Dietary supplement | Human milk-derived HMF |
| bovine milk-derived HMFbovine milk-derived HMF | Dietary supplement | Bovine milk-derived HMF |
Primary outcome
Average weight gain
Time frame: up to 3 weeks
Average weight gain measured as g/kg per day
5 secondary outcomes
Head circumference
Time frame: Weekly for 8 weeks
Length
Time frame: Weekly for 8 weeks
Feed intolerance
Time frame: 3 weeks
Electrolytes abnormalities
Time frame: 3 weeks
Need for additional signal nutrient supplementation
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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.
Belal Alshaikh, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human milk-derived HMF and bovine milk-derived HMF in people with Postnatal Growth Restriction and Necrotizing Enterocolitis, run by University of Calgary at 1 site in Canada.
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 5 inclusion and 4 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 7 Nov 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Belal Alshaikh, MD, MSc (4039561588, balshaik@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average weight gain (time frame: up to 3 weeks). 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 7 Nov 2022.