Weight GainNCT03604042
Comparison of Two Dose Adjustment Strategies of a Human Milk Protein Fortifier in Preterm Infants
A study testing Protein fortifier in people with Weight Gain, run by Société des Produits Nestlé (SPN) at 1 site in France.
Trial summary
The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen (standard of care) over a 21 day period. Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- Weight Gain
- What is being tested?
- Protein fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2017to 10 Feb 2020
- 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 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age in weeks: 23 weeks 0 days and 31 weeks 6 days.
- Birth weight less or equal to 1500 g
- Minimum enteral intake of 150-160 mL/kg/d fortified HM
- Parents, liable parent, or legal representative (LR) if applicable are willing and able to sign written informed consent and written informed consent is obtained prior to trial entry
Who cannot join
- Infants with weight z-score < -2 SD, based on the Fenton growth chart (Fenton 2013)
- Intra-ventricular hemorrhage (grade 3-4) determined using cranial ultrasonography or periventricular leukomalacia.
- Renal disease determined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased creatinine.
- Cholestasis (total bilirubin > 5 mg/dL or 85 umol/L and direct bilirubin > 20% of total bilirubin) associated with one or more abnormal liver function tests (AST, ALT, or GGT).
- Major congenital malformations that may impact ability to accept enteral feedings (i.e., severe cleft palate, etc.).
- Suspected or documented systemic or congenital infections (i.e., human immunodeficiency virus, cytomegalovirus, etc.).
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- Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth, e.g.,:
- NEC grade above or equal to 2
- Uncontrolled sepsis
- Suspected or documented maternal substance abuse:
- Born to mothers who smoked > 10 cigarettes per day during pregnancy
- Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (> 3 alcoholic beverages per week) during pregnancy
- Subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol
- Infants who have received any experimental treatment or received any other investigational intervention (procedure or product) unrelated to this trial, prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Regimens of Individualized, Adjustable Human Milk Fortification in Pretem Infants Using a New Modular Protein-only Fortifier
The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen (standard of care) over a 21 day period.
- Conditions
- Weight Gain
- Being tested
- Protein fortifier
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein fortifierCombination product
Protein Fortifier to be added to Fortified human milk according to feeding regimen
| Study group | Role | What they receive |
|---|---|---|
| Weight-driven protein fortification | Active comparator | Individualized protein fortification based on weight gain Receives: Combination Product: Protein fortifier |
| BUN-driven protein fortification | Experimental | Individualized protein fortification based on BUN concentrations Receives: Combination Product: Protein fortifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of weight gain
To compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a BUN-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen
Measured: From Day 6 to Day 27
Secondary outcomes (10)
Comparison of weight gain (g/day) of infants after 1 and 3 weeks of individualized protein fortification to weight gain during the 5-day period of standard Human Milk (HM) fortification
Comparison of weight gain (g/day) of infants after 1 and 3 weeks of individualized protein fortification to weight gain during the 5-day period of standard HM fortification
Measured: Day 6 to Day 13, and Day 6 to Day 27
Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)
Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)
Measured: Day 6 to Day 27 (minimum)
Changes in growth parameters: head circumference and head circumference gain (cm)
Changes in growth parameters: head circumference and head circumference gain (cm)
Measured: Day 6 to Day 27 (minimum)
Changes in growth parameters: BMI and BMI changes (kg body weight/m^2)
Changes in growth parameters: BMI and BMI changes (kg body weight/m^2)
Measured: Day 6 to Day 27 (minimum)
Body composition including lean fat mass and fat-free mass
Body composition including lean fat mass and fat-free mass
Measured: Day 6 to Day 27 (minimum)
Weight at hospital discharge
Weight at hospital discharge
Measured: Day 27 (minimum)
Macronutrient content in human milk
Macronutrient content in human milk using a Miris Human Milk Analyzer to measure the composition of the human milk
Measured: Day 6 to Day 27 (minimum)
Feeding and gastrointestinal (GI) tolerance
Feeding and gastrointestinal (GI) tolerance determined using Digestive tolerance scores based on four binary parameters (0 = absence or 1 = presence) collected in daily routine care: Sore abdomen, liquid stools, gastric residuals, and regurgitation or vomiting
Measured: Day 6 to Day 27 (minimum)
Safety evaluation including number of subjects with AEs
Safety evaluation including number of subjects with AEs
Measured: Day 1 to Day 27 (minimum)
Biochemistry markers collected from blood and urine as part of routine NICU standard of care
Biochemistry markers collected from blood and urine as part of routine NICU standard of care: Routine biochemistries in Blood/Serum and Urine (in spot urine samples), and Nutrition markers in Blood/serum: albumin, pre-albumin, alkaline phosphatase, triglycerides and vitamin D
Measured: Day 6 to Day 27 (minimum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start9 Oct 2017
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastien Paoli, Msc, Study chair, Nestlé Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604042
- Sponsor's protocol ID
- 13.01.INF
- Status last verified
- Mar 2020
- First submitted
- 26 Apr 2018
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Regimens of Individualized, Adjustable Human Milk Fortification in Pretem Infants Using a New Modular Protein-only Fortifier
- ClinicalTrials.gov ID
- NCT03604042
- Acronym / sponsor ID
- 13.01.INF
- Conditions
- Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 27 Jul 2018 (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.
The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen (standard of care) over a 21 day period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-driven protein fortification | Active comparator | Combination Product: Protein fortifierIndividualized protein fortification based on weight gain |
| BUN-driven protein fortification | Experimental | Combination Product: Protein fortifierIndividualized protein fortification based on BUN concentrations |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age in weeks: 23 weeks 0 days and 31 weeks 6 days.
- Birth weight less or equal to 1500 g
- Minimum enteral intake of 150-160 mL/kg/d fortified HM
- Parents, liable parent, or legal representative (LR) if applicable are willing and able to sign written informed consent and written informed consent is obtained prior to trial entry
Key exclusion criteria (14 listed)
- Infants with weight z-score < -2 SD, based on the Fenton growth chart (Fenton 2013)
- Intra-ventricular hemorrhage (grade 3-4) determined using cranial ultrasonography or periventricular leukomalacia.
- Renal disease determined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased creatinine.
- Cholestasis (total bilirubin > 5 mg/dL or 85 umol/L and direct bilirubin > 20% of total bilirubin) associated with one or more abnormal liver function tests (AST, ALT, or GGT).
- Major congenital malformations that may impact ability to accept enteral feedings (i.e., severe cleft palate, etc.).
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 fortifierProtein Fortifier to be added to Fortified human milk according to feeding regimen | Combination product | BUN-driven protein fortification, Weight-driven protein fortification |
Primary outcome
Comparison of weight gain
Time frame: From Day 6 to Day 27
To compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a BUN-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen
10 secondary outcomes
Comparison of weight gain (g/day) of infants after 1 and 3 weeks of individualized protein fortification to weight gain during the 5-day period of standard Human Milk (HM) fortification
Time frame: Day 6 to Day 13, and Day 6 to Day 27
Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)
Time frame: Day 6 to Day 27 (minimum)
Changes in growth parameters: head circumference and head circumference gain (cm)
Time frame: Day 6 to Day 27 (minimum)
Changes in growth parameters: BMI and BMI changes (kg body weight/m^2)
Time frame: Day 6 to Day 27 (minimum)
Body composition including lean fat mass and fat-free mass
Time frame: Day 6 to Day 27 (minimum)
Weight at hospital discharge
Time frame: Day 27 (minimum)
Macronutrient content in human milk
Time frame: Day 6 to Day 27 (minimum)
Feeding and gastrointestinal (GI) tolerance
Time frame: Day 6 to Day 27 (minimum)
Safety evaluation including number of subjects with AEs
Time frame: Day 1 to Day 27 (minimum)
Biochemistry markers collected from blood and urine as part of routine NICU standard of care
Time frame: Day 6 to Day 27 (minimum)
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 6 Mar 2020.
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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.
Sebastien Paoli, Msc study chair
Nestlé Research
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 fortifier in people with Weight Gain, run by Société des Produits Nestlé (SPN) at 1 site in France.
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 14 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 6 Mar 2020. 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 France. 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?
Comparison of weight gain (time frame: From Day 6 to Day 27). 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 6 Mar 2020.