Growth FailureFATNCT04809350
Human Milk Fortification With Adjustable Versus Targeted Method
A study testing Adjustable Human Milk Fortification and Targeted Human Milk Fortification in people with Growth Failure, run by University of Calgary at 1 site in Canada.
Trial summary
Research question: Do preterm infants born <1250 g achieve better weight gain with targeted fortification compared with the adjustable fortification of human milk? Hypothesis: Targeted fortification of human milk results in better weight gain in infants with birth weight <1250 gr when compared to the adjustable… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth Failure
- What is being tested?
- Adjustable Human Milk Fortification and Targeted Human Milk Fortification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 10 Nov 2023to 31 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants with birth weight <1250 g born at Foothills Medical Centre.
- Appropriate for gestational age (AGA) (according to Fenton's Charts).
Who cannot join
- Abnormal Newborn Metabolic Screen
- Major congenital anomalies intervention.
- Patients who develop NEC prior to enrollment.
- Patients with confirmed congenital Toxoplasmosis, Syphilis, Rubella, Cytomegalovirus, Herpes simplex virus, Varicella and/or Zika (TORCH infections).
- Patients receiving systemic steroids.
- Patients with acute kidney injury (AKI).
Trial locations and contacts
1 site in 1 country.
Adriana Reyes Loredo, MD contact
Canada1 site, 1 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N2T9
Belal Alshaikh, MD
Belal Alshaikh, MD
About this study
Official title: Effect of Adjustable Versus Targeted Human Milk Fortification on Weight Gain in Preterm Infants With Birth Weight <1250 g: A Randomized Controlled Trial
Research question: Do preterm infants born <1250 g achieve better weight gain with targeted fortification compared with the adjustable fortification of human milk?
Hypothesis: Targeted fortification of human milk results in better weight gain in infants with birth weight <1250 gr when compared to the adjustable fortification.
Study design: Open-label, pragmatic, parallel randomized controlled trial in appropriate for gestational age infants with birth weight <1250 g.
Read the detailed description
Human milk is the ideal diet for neonates. However, it does not provide enough energy, protein, and sodium to meet the nutritional requirements of very preterm infants. Postnatal growth failure is common despite the current use of human milk fortifiers. The main human milk fortification methods include:
- standard HM fortification (SF) which assumes an average composition of breast milk and adds fortifiers in a fixed dosage. It does not account for variations of nutrient content in human milk
- Individualized human milk fortification which encompasses two methods:
- Adjustable HM fortification (AF): Protein supplementation is provided in addition to SF according to blood urea nitrogen (BUN) concentration which reflects the infant's metabolic response to protein intake. However, there are clinical scenarios in which the BUN levels are not a reliable marker of protein intake, such as acute kidney injury.
- Targeted HM fortification (TF): Based on routine analyses of HM that are used to adjust fortification to meet the recommended requirements for infants. It does not take into consideration that the requirements of infants may vary.
SF has frequently failed to achieve appropriate weight gain, while individualized (AF or TF) fortification seems to have better performance. However, the evidence to support one method over the other is lacking.
The objective of the study is to compare weekly average weight gain between preterm infants on AF versus TF.
Once the written consent is obtained, the infant will be randomized to AF or TF. The sequence code will be kept in sequential numbered sealed envelopes. Infants from multiple births will be included as 1 unit and randomized to the same arm of the study.
For patients allocated to the TF group, breast milk will be analyzed twice weekly for energy, protein, and sodium contents. The daily protein, fat, and sodium intakes will be then calculated and optimized to meet the recommended dietary reference intake (DRI) for preterm infants with birth weight <1250 g.
For patients allocated to the AF group, weekly BUN measurements will be performed. Based on BUN concentrations, the liquid protein will be added to achieve the targeted BUN level. Additional calories will be added using formula if growth is suboptimal or DRI is not met based on the assumed human milk content for protein and energy.
The intervention will last 4-8 weeks. For all patients, the day the first BUN concentration and milk analyses are done will be day 1 of intervention. The following measurements will be performed on days 7-8, 14-16, 21-23, and 28-30 of intervention: Weight (grams), length and head circumference (centimeters), BUN and sodium concentrations.
Data on maternal and neonatal characteristics will be collected from their electronic and physical charts.
- Conditions
- Growth Failure
- Being tested
- Adjustable Human Milk Fortification, Targeted Human Milk Fortification
- Keywords
- Human milk, Fortification, Preterm infants
- Medical subject headings
- Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable Human Milk FortificationDietary supplement
BUN and sodium concentrations will be measured every week in infants on full enteral feeds with fortified human milk.
Liquid protein will be added based on serum urea.
Targeted Human Milk FortificationDietary supplement
Human milk will be analyzed twice weekly. Before the day of analysis, each mother will store fresh milk pumped from 10:00 AM until 8:00 AM of the previous day in a refrigerator and bring it to the hospital.
Protein, fat, and sodium supplementation will be added to the human milk to meet the recommended daily intakes.
| Study group | Role | What they receive |
|---|---|---|
| Adjustable Human Milk Fortification | Active comparator | Human milk fortification based on blood urea levels Receives: Dietary Supplement: Adjustable Human Milk Fortification |
| Targeted Human Milk Fortification | Experimental | Human milk fortification based on milk analysis Receives: Dietary Supplement: Targeted Human Milk Fortification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average weight gain in infants on Adjustable versus Targeted human milk fortification
Average weight gain measured as g/kg per day
Measured: Weekly for 8 weeks
Secondary outcomes (3)
Anthropometrics in infants on Adjustable versus Targeted human milk fortification
Measurement of head circumference and length in centimeters.
Measured: Weekly for 8 weeks
BUN concentration in infants on Adjustable versus Targeted human milk fortification
mmol/L
Measured: Weekly for 4 weeks
Incidence of extra uterine growth restriction
Defined as weight less than 10th percentile at 36 weeks corrected age (CA)
Measured: At 36 weeks CA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start10 Nov 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth FailureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Belal Alshaikh, MD, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809350
- Sponsor's protocol ID
- REB20-2139
- Acronym
- FAT
- Status last verified
- Nov 2023
- First submitted
- 18 Mar 2021
- Last updated
- 30 Nov 2023
- 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 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adjustable Versus Targeted Human Milk Fortification on Weight Gain in Preterm Infants With Birth Weight <1250 g: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04809350
- Acronym / sponsor ID
- FAT / REB20-2139
- Conditions
- Growth Failure
- Keywords
- Human milk, Fortification, Preterm infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 22 Mar 2021 (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.
Research question: Do preterm infants born <1250 g achieve better weight gain with targeted fortification compared with the adjustable fortification of human milk?
Hypothesis: Targeted fortification of human milk results in better weight gain in infants with birth weight <1250 gr when compared to the adjustable fortification.
Study design: Open-label, pragmatic, parallel randomized controlled trial in appropriate for gestational age infants with birth weight <1250 g.
Detailed description
Human milk is the ideal diet for neonates. However, it does not provide enough energy, protein, and sodium to meet the nutritional requirements of very preterm infants. Postnatal growth failure is common despite the current use of human milk fortifiers. The main human milk fortification methods include:
- standard HM fortification (SF) which assumes an average composition of breast milk and adds fortifiers in a fixed dosage. It does not account for variations of nutrient content in human milk
- Individualized human milk fortification which encompasses two methods:
- Adjustable HM fortification (AF): Protein supplementation is provided in addition to SF according to blood urea nitrogen (BUN) concentration which reflects the infant's metabolic response to protein intake. However, there are clinical scenarios in which the BUN levels are not a reliable marker of protein intake, such as acute kidney injury.
- Targeted HM fortification (TF): Based on routine analyses of HM that are used to adjust fortification to meet the recommended requirements for infants. It does not take into consideration that the requirements of infants may vary.
SF has frequently failed to achieve appropriate weight gain, while individualized (AF or TF) fortification seems to have better performance. However, the evidence to support one method over the other is lacking.
The objective of the study is to compare weekly average weight gain between preterm infants on AF versus TF.
Once the written consent is obtained, the infant will be randomized to AF or TF. The sequence code will be kept in sequential numbered sealed envelopes. Infants from multiple births will be included as 1 unit and randomized to the same arm of the study.
For patients allocated to the TF group, breast milk will be analyzed twice weekly for energy, protein, and sodium contents. The daily protein, fat, and sodium intakes will be then calculated and optimized to meet the recommended dietary reference intake (DRI) for preterm infants with birth weight <1250 g.
For patients allocated to the AF group, weekly BUN measurements will be performed. Based on BUN concentrations, the liquid protein will be added to achieve the targeted BUN level. Additional calories will be added using formula if growth is suboptimal or DRI is not met based on the assumed human milk content for protein and energy.
The intervention will last 4-8 weeks. For all patients, the day the first BUN concentration and milk analyses are done will be day 1 of intervention. The following measurements will be performed on days 7-8, 14-16, 21-23, and 28-30 of intervention: Weight (grams), length and head circumference (centimeters), BUN and sodium concentrations.
Data on maternal and neonatal characteristics will be collected from their electronic and physical charts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjustable Human Milk Fortification | Active comparator | Dietary Supplement: Adjustable Human Milk FortificationHuman milk fortification based on blood urea levels |
| Targeted Human Milk Fortification | Experimental | Dietary Supplement: Targeted Human Milk FortificationHuman milk fortification based on milk analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Infants with birth weight <1250 g born at Foothills Medical Centre.
- Appropriate for gestational age (AGA) (according to Fenton's Charts).
Key exclusion criteria (6 listed)
- Abnormal Newborn Metabolic Screen
- Major congenital anomalies intervention.
- Patients who develop NEC prior to enrollment.
- Patients with confirmed congenital Toxoplasmosis, Syphilis, Rubella, Cytomegalovirus, Herpes simplex virus, Varicella and/or Zika (TORCH infections).
- Patients receiving systemic steroids.
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 |
|---|---|---|
| Adjustable Human Milk FortificationBUN and sodium concentrations will be measured every week in infants on full enteral feeds with fortified human milk. Liquid protein will be added based on serum urea. | Dietary supplement | Adjustable Human Milk Fortification |
| Targeted Human Milk FortificationHuman milk will be analyzed twice weekly. Before the day of analysis, each mother will store fresh milk pumped from 10:00 AM until 8:00 AM of the previous day in a refrigerator and bring it to the hospital. Protein, fat, and sodium supplementation will be added to the human milk to meet the recommended daily intakes. | Dietary supplement | Targeted Human Milk Fortification |
Primary outcome
Average weight gain in infants on Adjustable versus Targeted human milk fortification
Time frame: Weekly for 8 weeks
Average weight gain measured as g/kg per day
3 secondary outcomes
Anthropometrics in infants on Adjustable versus Targeted human milk fortification
Time frame: Weekly for 8 weeks
BUN concentration in infants on Adjustable versus Targeted human milk fortification
Time frame: Weekly for 4 weeks
Incidence of extra uterine growth restriction
Time frame: At 36 weeks CA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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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.
Adriana Reyes Loredo, MD contact
Belal Alshaikh, MD, MSc 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 Adjustable Human Milk Fortification and Targeted Human Milk Fortification in people with Growth Failure, 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 2 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 30 Nov 2023. 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 N 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 in infants on Adjustable versus Targeted human milk fortification (time frame: Weekly for 8 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 30 Nov 2023.