Premature BirthNCT01771588
Human Milk Fortifier - Growth Evaluation
A study testing Human milk fortifier in people with Premature Birth, run by Société des Produits Nestlé (SPN) at 11 sites in 5 countries.
Trial summary
It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Premature Birth
- What is being tested?
- Human milk fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 11 sitesin 5 countries
- Study dates
- Apr 2011to Mar 2015
- 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 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof)
- Male or female
- Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h
- Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d.
- Written informed consent has been obtained from the legal representative(s).
Who cannot join
- Infants with current systemic disease
- Infants with a history of systemic disease
- Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery.
- Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age.
- Infants diagnosed with any inherent metabolic disease.
- Infants diagnosed with any chromosomic disease.
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- Receiving any commercial formula supplementation to breast milk.
- Receiving steroids at the time of enrollment.
- Participation in another nutritional clinical trial that may affect outcomes of this study.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
France7 sites
Hôpital des Enfants - CHU Pellegrin
Bordeaux, 33000
CHU Caen
Caen, 14033
CHU Grenoble
Grenoble, 38043
Hôpital de la Croix-Rousse
Lyon, 69317
Hôpital de la Conception Marseille
Marseille, 13005
Maternité Régionale
Nancy, 54042
Hôpital Clocheville Tours
Tours, 37000
About this study
Official title: Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier
It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.
- Conditions
- Premature Birth
- Being tested
- Human milk fortifier
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human milk fortifierDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| New human milk fortifier | Experimental | New human milk fortifier Receives: Dietary Supplement: Human milk fortifier |
| Currently marketed fortifier | Active comparator | Currently marketed fortifier Receives: Dietary Supplement: Human milk fortifier |
| New human milk fortifier with new Ca source | Experimental | a subgroup of patients will receive the new milk fortifier containing a new source of calcium. Receives: Dietary Supplement: Human milk fortifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startApr 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771588
- Sponsor's protocol ID
- 08.08.INF
- Status last verified
- May 2016
- First submitted
- 8 Jan 2013
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rigo J, Hascoet JM, Billeaud C, Picaud JC, Mosca F, Rubio A, Saliba E, Radke M, Simeoni U, Guillois B, de Halleux V, Jaeger J, Ameye L, Hays NP, Spalinger J. Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2017 Oct;65(4):e83-e93. doi: 10.1097/MPG.0000000000001686.
PubMed 28727654
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier
- ClinicalTrials.gov ID
- NCT01771588
- Acronym / sponsor ID
- 08.08.INF
- Conditions
- Premature Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Jan 2013 (estimated)
- 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.
It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New human milk fortifier | Experimental | Dietary Supplement: Human milk fortifierNew human milk fortifier |
| Currently marketed fortifier | Active comparator | Dietary Supplement: Human milk fortifierCurrently marketed fortifier |
| New human milk fortifier with new Ca source | Experimental | Dietary Supplement: Human milk fortifiera subgroup of patients will receive the new milk fortifier containing a new source of calcium. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof)
- Male or female
- Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h
- Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d.
- Written informed consent has been obtained from the legal representative(s).
Key exclusion criteria (9 listed)
- Infants with current systemic disease
- Infants with a history of systemic disease
- Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery.
- Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age.
- Infants diagnosed with any inherent metabolic disease.
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 fortifier | Dietary supplement | Currently marketed fortifier, New human milk fortifier, New human milk fortifier with new Ca source |
Primary outcome
Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day.
Time frame: 21 days
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 5 May 2016.
- Derived from this study: PubMed 28727654Rigo J, Hascoet JM, Billeaud C, Picaud JC, Mosca F, Rubio A, Saliba E, Radke M, Simeoni U, Guillois B, de Halleux V, Jaeger J, Ameye L, Hays NP, Spalinger J. Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2017 Oct;65(4):e83-e93. doi: 10.1097/MPG.0000000000001686.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human milk fortifier in people with Premature Birth, run by Société des Produits Nestlé (SPN) at 11 sites in 5 countries.
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 9 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 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Belgium, Germany, Italy, Switzerland. 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?
Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day. (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01771588, which also lists 1 linked publication.
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 5 May 2016; AzTrials last refreshed its copy on 28 Oct 2026.