PretermFORTINNCT04982133
Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification
A study testing Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment in people with Preterm and Very Low Birth Weight Infant, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Preterm, Very Low Birth Weight Infant, Feeding, Breast
- What is being tested?
- Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 19 Apr 2021to 30 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Preterm infants born <1000 g of birth weight that are fed with breast milk or donated milk.
- Written informed consent signed by the mother, father or legal guardian.
- To tolerate enteral feeding, at least 100mL / kg / day.
Who cannot join
- Non-premature or premature patients weighing ≥ 1000 gr.
- Patients with major malformations.
- Patients with diagnosed chromosomal diseases or of high diagnostic suspicion.
- Patients with short bowel syndrome or any surgery on the gastrointestinal tract.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Trial Weight Gain in Extremely Premature Infant: Targeted Versus Adjusted Fortification
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
Read the detailed description
- Study design This is an interventional, randomized, controlled study.
- Description of the study The very premature newborn will be identified by daily evaluation of the infants admitted for consultation in the income book. Informed consent will be requested from the infant´s father, mother or legal guardian between the fifth and tenth day of life. Fortification will be done according to the randomization group.
- Outline of the study design
- Excel calculation sheet of individualized supplementation according to the composition of breast milk in the target fortification group. Methodology of analysis of breast milk in FOSS analyzer.
- In the adjusted fortification group, urea concentration levels will be kept between 19-30 mg / dL
- Fenton curves or https://www.growthcalculator.org/ will be used for Z-scores calculation.
- Growth speed calculation: Weight gain: (1000x ln [Final weight / Initial weight]) / number of days. 4 Duration of the study for each participant The duration of participation in the study and the fortification intervention period will be a maximum of 132 days.
- Being tested
- Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
- Keywords
- preterm, nutrition, human milk fortified
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementation based on plasma urea concentration every other week or human milk analysis on experimentDietary supplement
Also called Macronutrient supplementation based on human milk analysis
At the time that the doctor decides to start fortification, it will be done according to urea levels in active comparator arm or human milk analysis on experimental group.
In Group A, fortification at 4% is started, and according to plasma urea control every 15 days the fortification is modified.
In Group B, fortification is adjusted based on the macronutrient analysis of breast or donated milk.
| Study group | Role | What they receive |
|---|---|---|
| Fortification adjusted according to urea | Active comparator | Fortification adjusted according to urea with FM 85 at 4% and oligopeptides. In this arm, fortification at 4% is started, and according to plasma urea control every 15 days the fortification is modified. Receives: Dietary Supplement: Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment |
| Individualized fortification according to the nutritional characteristics of breast milk | Experimental | Individualized fortification according to the nutritional characteristics of the mother's own milk or pasteurized milk taken by the premature infant.
In this arm, fortification is adjusted based on the macronutrient analysis of breast milk or donated twice weekly. Receives: Dietary Supplement: Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth rate 28 days after the start of fortification and birth
To investigate the effect on weight gain during admission of individualized fortification, according to milk analysis, versus fortification adjusted according to urea level.
Measured: 28 days
Secondary outcomes (1)
Mineralization differences between both fortication methods
Difference in phosphate and alkaline phosphatase values
Measured: Until 36 weeks of postmenstrual age (EPM) or at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start19 Apr 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esperanza Escribano, Hospital Universitario La Paz
- Investigators
- MARTA CABRERA, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982133
- Sponsor's protocol ID
- HULP5704
- Acronym
- FORTIN
- Status last verified
- Jan 2024
- First submitted
- 5 Jul 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results reported in this article after deidentification (text, tables, figures and appendices) will be available upon request. Data will be available 3 months to 5 years after publication of the article. Other documents will be available: study protocol, informed consent form. Researchers submitting a methodologically sound proposal should contact miguel.saenz@salud.madrid.org. In order to access, requesters will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Weight Gain in Extremely Premature Infant: Targeted Versus Adjusted Fortification
- ClinicalTrials.gov ID
- NCT04982133
- Acronym / sponsor ID
- FORTIN / HULP5704
- Keywords
- preterm, nutrition, human milk fortified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 29 Jul 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.
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
Detailed description
- Study design This is an interventional, randomized, controlled study.
- Description of the study The very premature newborn will be identified by daily evaluation of the infants admitted for consultation in the income book. Informed consent will be requested from the infant´s father, mother or legal guardian between the fifth and tenth day of life. Fortification will be done according to the randomization group.
- Outline of the study design
- Excel calculation sheet of individualized supplementation according to the composition of breast milk in the target fortification group. Methodology of analysis of breast milk in FOSS analyzer.
- In the adjusted fortification group, urea concentration levels will be kept between 19-30 mg / dL
- Fenton curves or https://www.growthcalculator.org/ will be used for Z-scores calculation.
- Growth speed calculation: Weight gain: (1000x ln [Final weight / Initial weight]) / number of days. 4 Duration of the study for each participant The duration of participation in the study and the fortification intervention period will be a maximum of 132 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fortification adjusted according to urea | Active comparator | Dietary Supplement: Protein supplementation based on plasma urea concentration every other week or human milk analysis on experimentFortification adjusted according to urea with FM 85 at 4% and oligopeptides. In this arm, fortification at 4% is started, and according to plasma urea control every 15 days the fortification is modified. |
| Individualized fortification according to the nutritional characteristics of breast milk | Experimental | Dietary Supplement: Protein supplementation based on plasma urea concentration every other week or human milk analysis on experimentIndividualized fortification according to the nutritional characteristics of the mother's own milk or pasteurized milk taken by the premature infant. In this arm, fortification is adjusted based on the macronutrient analysis of breast milk or donated twice weekly. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preterm infants born <1000 g of birth weight that are fed with breast milk or donated milk.
- Written informed consent signed by the mother, father or legal guardian.
- To tolerate enteral feeding, at least 100mL / kg / day.
Key exclusion criteria (4 listed)
- Non-premature or premature patients weighing ≥ 1000 gr.
- Patients with major malformations.
- Patients with diagnosed chromosomal diseases or of high diagnostic suspicion.
- Patients with short bowel syndrome or any surgery on the gastrointestinal tract.
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 |
|---|---|---|
| Protein supplementation based on plasma urea concentration every other week or human milk analysis on experimentAlso: Macronutrient supplementation based on human milk analysisAt the time that the doctor decides to start fortification, it will be done according to urea levels in active comparator arm or human milk analysis on experimental group. In Group A, fortification at 4% is started, and according to plasma urea control every 15 days the fortification is modified. In Group B, fortification is adjusted based on the macronutrient analysis of breast or donated milk. | Dietary supplement | Fortification adjusted according to urea, Individualized fortification according to the nutritional characteristics of breast milk |
Primary outcome
Growth rate 28 days after the start of fortification and birth
Time frame: 28 days
To investigate the effect on weight gain during admission of individualized fortification, according to milk analysis, versus fortification adjusted according to urea level.
1 secondary outcome
Mineralization differences between both fortication methods
Time frame: Until 36 weeks of postmenstrual age (EPM) or at discharge
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 23 Jan 2024.
- Individual participant dataSharing planned: Yes. Individual participant data underlying the results reported in this article after deidentification (text, tables, figures and appendices) will be available upon request. Data will be available 3 months to 5 years after publication of the article. Other documents will be available: study protocol, informed consent form. Researchers submitting a methodologically sound proposal should contact miguel.saenz@salud.madrid.org. In order to access, requesters will need to sign a data access agreement.
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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.
MARTA CABRERA principal investigator
La Paz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment in people with Preterm and Very Low Birth Weight Infant, run by Hospital Universitario La Paz at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 23 Jan 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 Spain. 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?
Growth rate 28 days after the start of fortification and birth (time frame: 28 days). 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 23 Jan 2024.