GrowthNCT03276663
Growth of Healthy Term Infants Fed a Partially Hydrolyzed Follow-up Formula
A study testing Formula feeding regimen in people with Growth, run by Société des Produits Nestlé (SPN) at 6 sites in France.
Trial summary
Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of an existing partially hydrolyzed starter formula, then subsequently fed a partially hydrolyzed follow-up formula over the first year of life. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Formula feeding regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 6 sitesFrance
- Study dates
- 18 Sep 2017to 3 Jun 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 Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having obtained his/her parents' (or his/her legally accepted representative's [LAR's]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of all pertinent aspects of the study.
- Age ≤ 14 days after birth (date of birth = Day 0).
- Full-term gestational birth (≥ 37 and ≤ 42 weeks).
- Weight at birth ≥ 2500 g and ≤ 4200 g
- Born to mothers with (normal) pre-pregnancy BMI ≥ 18.5 to < 26 kg/m2.
- For formula-fed infants: born to mothers who independently elected, before study enrollment, not to breastfeed, but having received any HM is permitted (not applicable for infants in the HM-fed group)
Show all 9Show fewer
- For HM-fed infants: mothers intend to provide breast milk until age 6 months
- Infant's parent(s)/LAR is of legal age of consent, has sufficient command of the French language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol.
- Infant's parent(s)/LAR is able to be contacted directly by telephone throughout the study.
Who cannot join
- Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria).
- 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.
- Cognitive or physical developmental disorders (e.g., malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader Willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders).
- Participation in any other clinical trial prior to enrollment.
- Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Amiens Picardie Site SUD
Amiens, 80054
CHU Bordeaux - Hôpital Pellegrin Enfants
Bordeaux, 33000
CHU de Caen
Caen, 14033
CHU Nantes - Hôpital Mère-Enfant
Nantes, 44093
Hopital Necker
Paris, 75015
Biofortis CIC
Saint-Herblain, 44800
About this study
Official title: Effect of a New Formula With a Reduced Concentration of Partially Hydrolyzed Protein on Growth of Healthy Term Infants: an Open-label Study
Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of an existing partially hydrolyzed starter formula, then subsequently fed a partially hydrolyzed follow-up formula over the first year of life.
- Conditions
- Growth
- Being tested
- Formula feeding regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula feeding regimenOther
The feeding regimen consists of an existing commercial starter formula followed by a new follow-up formula
| Study group | Role | What they receive |
|---|---|---|
| Formula fed group | Other | Formula feeding regimen Receives: Other: Formula feeding regimen |
| Human milk-fed group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth velocity (weight gain in g/day) of healthy term formula-fed infants during the first 6 months
compared to the WHO reference standards or to the human milk (HM)-fed comparator group.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start18 Sep 2017
- Primary completion19 Dec 2019
- Study completion3 Jun 2020
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 GrowthStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, two-arm
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Responsible party
- Sponsor
- Investigators
- Claude Billeaud, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276663
- Sponsor's protocol ID
- 15.01.INF
- Status last verified
- Jul 2020
- First submitted
- 7 Sep 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Billeaud C, Adamon L, Piloquet H, Hays NP, Dupuis L, Metreau I, Leke A. A new partially hydrolyzed whey-based follow-on formula with age-adapted protein content supports healthy growth during the first year of life. Front Pediatr. 2022 Sep 28;10:937882. doi: 10.3389/fped.2022.937882. eCollection 2022.
PubMed 36245743
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a New Formula With a Reduced Concentration of Partially Hydrolyzed Protein on Growth of Healthy Term Infants: an Open-label Study
- ClinicalTrials.gov ID
- NCT03276663
- Acronym / sponsor ID
- 15.01.INF
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 8 Sep 2017 (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.
Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of an existing partially hydrolyzed starter formula, then subsequently fed a partially hydrolyzed follow-up formula over the first year of life.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, two-arm
| Arm | Type | Receives |
|---|---|---|
| Formula fed group | Other | Other: Formula feeding regimenFormula feeding regimen |
| Human milk-fed group | No intervention | – |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Having obtained his/her parents' (or his/her legally accepted representative's [LAR's]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of all pertinent aspects of the study.
- Age ≤ 14 days after birth (date of birth = Day 0).
- Full-term gestational birth (≥ 37 and ≤ 42 weeks).
- Weight at birth ≥ 2500 g and ≤ 4200 g
- Born to mothers with (normal) pre-pregnancy BMI ≥ 18.5 to < 26 kg/m2.
Key exclusion criteria (6 listed)
- Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria).
- 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.
- Cognitive or physical developmental disorders (e.g., malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader Willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders).
- Participation in any other clinical trial prior to enrollment.
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 |
|---|---|---|
| Formula feeding regimenThe feeding regimen consists of an existing commercial starter formula followed by a new follow-up formula | Other | Formula fed group |
Primary outcome
Growth velocity (weight gain in g/day) of healthy term formula-fed infants during the first 6 months
Time frame: 6 month
compared to the WHO reference standards or to the human milk (HM)-fed comparator group.
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 7 Jul 2020.
- Derived from this study: PubMed 36245743Billeaud C, Adamon L, Piloquet H, Hays NP, Dupuis L, Metreau I, Leke A. A new partially hydrolyzed whey-based follow-on formula with age-adapted protein content supports healthy growth during the first year of life. Front Pediatr. 2022 Sep 28;10:937882. doi: 10.3389/fped.2022.937882. eCollection 2022.
Related trials for Growth
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 1/2
A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
EGFR-Mutant Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
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.
Claude Billeaud principal investigator
University Hospital, Bordeaux
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula feeding regimen in people with Growth, run by Société des Produits Nestlé (SPN) at 6 sites 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 9 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: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Growth velocity (weight gain in g/day) of healthy term formula-fed infants during the first 6 months (time frame: 6 month). 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 NCT03276663, 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 7 Jul 2020.