GrowthHASINCT04736082
Safety of an Infant Formula With Hydrolysed Protein in Term Infants
A study testing Intervention Group: Infant Formula with hydrolyzed protein in people with Growth, run by HiPP GmbH & Co. Vertrieb KG at 1 site in Germany.
Trial summary
A multi-centre, randomised, double-blind, parallel-group, controlled, prospective, non-inferiority intervention clinical trial is performed to assess the safety and suitability of an infant formula manufactured from extensively hydrolysed protein by showing normal growth of healthy term infants during the first 120… Read more about this study
- Who is it for?
- Ages 0 to 25 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Intervention Group: Infant Formula with hydrolyzed protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteGermany
- Study dates
- 16 Mar 2021to 27 Oct 2021
- 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 0 to 25 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female term infants until 25 days of age from singleton pregnancies
- Gestational age ≥37+0 weeks until 41+6 weeks
- Birth weight between ≥3rd and ≤97th percentile per gestational age
- Infants whose parent(s) / legally authorized representative(s) have reached the legal age of consent
- Infants whose parent(s) / legally authorized representative(s) are capable of and willing to comply with the protocol and have signed the informed consent form in accordance with legal requirements
- Infant formula group
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- Infants of mothers, who could not breastfeed their healthy newborn babies for reasons not related to this study, or who decided despite the advice on the benefits of breastfeeding to start exclusive formula-feeding within the first 25 days of age of their infant.
- Parent(s) / legally authorized representative(s) confirm their intention to feed their infant the investigational product as the only source of nutrition from 26 days of age onward through the duration of the main study (until 120 days of age), and agree that no other infant formula, drinks (water, tea, juice,…) or complementary foods will be introduced until the infant reaches the age of 120 days.
- Breastfeeding reference group
- Infants of mothers, who decided to exclusively breastfeed their infant until at least 120 days of age
- Parent(s) / legally authorized representative(s) confirm their intention to breastfeed their infant as the only source of nutrition, from 26 days of age onward throughout the duration of the main study (until 120 days of age), and agree that no other infant formula, liquids (water, tea, juice,…) or complementary foods will be introduced until the infant reaches the age of 120 days.
Who cannot join
- Infants whose biological parents or full siblings have a history of doctor's diagnosed atopic diseases (atopic dermatitis, hay fever, allergic asthma or rhinitis) and have been in medical treatment prior to or at enrolment visit
- Intensive care prior to or at enrolment visit
- Severe acquired or congenital illness, or chromosomal anomalies (if known) in infants that are expected to interfere with normal feed or growth
- Hypo- or hypertrophy <3rd or >97th percentile of birth weight per gestational age
- Infants under (ongoing) antibiotic treatment before or at enrolment visit longer than three days (72 hours)
- Infants requiring infant formula intake other than those specified in the protocol
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- Feeding difficulties or infant formula intolerance
- Disease of parents that may have an impact on study conduct or that may have an influence on infant growth and feeding behaviour based on the investigator's opinion
- Recreational drug or alcohol intake by the mother during the last two trimesters of pregnancy
- Infants born to mothers with medical conditions which have an effect on the infants' gastrointestinal tract/ability to be fed and/or growth (e.g. insulin dependent diabetes mellitus)
- Participation in another clinical intervention study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Suitability of an Infant Formula Manufactured From Extensively Hydrolysed Protein in Healthy Term Infants
A multi-centre, randomised, double-blind, parallel-group, controlled, prospective, non-inferiority intervention clinical trial is performed to assess the safety and suitability of an infant formula manufactured from extensively hydrolysed protein by showing normal growth of healthy term infants during the first 120 days of life with an optional follow up until 180 days of life.
Read the detailed description
Since many years the use of infant formulae manufactured from hydrolysed proteins are recommended for infants at risk for developing allergies if they cannot be exclusively breast-fed. Although the use of such formulae manufactured from hydrolysed protein is legally authorized according to the respective legal framework since many years (currently: Directive 2006/141/EC), the safety of each hydrolysed protein has to be substantiated by additional clinical data according to new legal requirements (Del. Regulation (EU) 2016/127). This study is intended to generate clinical safety data: demonstrating adequate growth of infants fed a formula manufactured from hydrolysed protein in comparison to infants fed a formula manufactured from intact protein. As formula manufactured from hydrolyzed proteins is known to have beneficial effects on gastrointestinal comfort, it is also fed to infants not at risk for developing allergies. Therefore, this study additionally investigates the impact of hydrolysed protein on gastrointestinal tolerance.
- Conditions
- Growth
- Being tested
- Intervention Group: Infant Formula with hydrolyzed protein, Control Group: Infant Formula with intact protein
- Keywords
- Safety, Growth, Weight Gain, Infant Formula, Infants
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group: Infant Formula with hydrolyzed proteinOther
Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (intervention formula manufactured from extensively hydrolysed whey protein).
Control Group: Infant Formula with intact proteinOther
Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (control formula manufactured from intact cow's milk protein).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Infant Formula with hydrolyzed protein | Experimental | Infants will receive the following infant formula: Infant formula manufactured from extensively hydrolyzed proteins and containing pre- and probiotics. Receives: Other: Intervention Group: Infant Formula with hydrolyzed protein |
| Control Group: Infant Formula with intact protein | Active comparator | Infants will receive the following infant formula: Infant formula manufactured from intact proteins and containing pre- and probiotics. Receives: Other: Control Group: Infant Formula with intact protein |
| Breast Fed Group | No intervention | Exclusively breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant daily weight gain (in g/day) between 30 days and 120 days of age
Measured: 90 days duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start16 Mar 2021
- Primary completion31 Aug 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Waldkrankenhaus Protestant Hospital, Spandau, Biofortis, Merieux NutriSciences, HungaroTrial
- Responsible party
- Sponsor
- Investigators
- Frank Jochum, PD Dr. med., Principal investigator, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736082
- Sponsor's protocol ID
- 508917-2
- Acronym
- HASI
- Status last verified
- Nov 2021
- First submitted
- 29 Jan 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Suitability of an Infant Formula Manufactured From Extensively Hydrolysed Protein in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT04736082
- Acronym / sponsor ID
- HASI / 508917-2
- Conditions
- Growth
- Keywords
- Safety, Growth, Weight Gain, Infant Formula, Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KGIndustry (pharma, biotech, devices)
- Collaborators
- Waldkrankenhaus Protestant Hospital, Spandau, Biofortis, Merieux NutriSciences, HungaroTrial
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 3 Feb 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.
A multi-centre, randomised, double-blind, parallel-group, controlled, prospective, non-inferiority intervention clinical trial is performed to assess the safety and suitability of an infant formula manufactured from extensively hydrolysed protein by showing normal growth of healthy term infants during the first 120 days of life with an optional follow up until 180 days of life.
Detailed description
Since many years the use of infant formulae manufactured from hydrolysed proteins are recommended for infants at risk for developing allergies if they cannot be exclusively breast-fed. Although the use of such formulae manufactured from hydrolysed protein is legally authorized according to the respective legal framework since many years (currently: Directive 2006/141/EC), the safety of each hydrolysed protein has to be substantiated by additional clinical data according to new legal requirements (Del. Regulation (EU) 2016/127). This study is intended to generate clinical safety data: demonstrating adequate growth of infants fed a formula manufactured from hydrolysed protein in comparison to infants fed a formula manufactured from intact protein. As formula manufactured from hydrolyzed proteins is known to have beneficial effects on gastrointestinal comfort, it is also fed to infants not at risk for developing allergies. Therefore, this study additionally investigates the impact of hydrolysed protein on gastrointestinal tolerance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Infant Formula with hydrolyzed protein | Experimental | Other: Intervention Group: Infant Formula with hydrolyzed proteinInfants will receive the following infant formula: Infant formula manufactured from extensively hydrolyzed proteins and containing pre- and probiotics. |
| Control Group: Infant Formula with intact protein | Active comparator | Other: Control Group: Infant Formula with intact proteinInfants will receive the following infant formula: Infant formula manufactured from intact proteins and containing pre- and probiotics. |
| Breast Fed Group | No intervention | –Exclusively breast milk |
Who may qualify
- Ages
- 0 to 25 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Healthy male or female term infants until 25 days of age from singleton pregnancies
- Gestational age ≥37+0 weeks until 41+6 weeks
- Birth weight between ≥3rd and ≤97th percentile per gestational age
- Infants whose parent(s) / legally authorized representative(s) have reached the legal age of consent
- Infants whose parent(s) / legally authorized representative(s) are capable of and willing to comply with the protocol and have signed the informed consent form in accordance with legal requirements
Key exclusion criteria (11 listed)
- Infants whose biological parents or full siblings have a history of doctor's diagnosed atopic diseases (atopic dermatitis, hay fever, allergic asthma or rhinitis) and have been in medical treatment prior to or at enrolment visit
- Intensive care prior to or at enrolment visit
- Severe acquired or congenital illness, or chromosomal anomalies (if known) in infants that are expected to interfere with normal feed or growth
- Hypo- or hypertrophy <3rd or >97th percentile of birth weight per gestational age
- Infants under (ongoing) antibiotic treatment before or at enrolment visit longer than three days (72 hours)
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 |
|---|---|---|
| Intervention Group: Infant Formula with hydrolyzed proteinInfants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (intervention formula manufactured from extensively hydrolysed whey protein). | Other | Intervention Group: Infant Formula with hydrolyzed protein |
| Control Group: Infant Formula with intact proteinInfants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (control formula manufactured from intact cow's milk protein). | Other | Control Group: Infant Formula with intact protein |
Primary outcome
Infant daily weight gain (in g/day) between 30 days and 120 days of age
Time frame: 90 days duration
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 26 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Frank Jochum, PD Dr. med. principal investigator
Evangelisches Waldkrankenhaus Spandau, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group: Infant Formula with hydrolyzed protein in people with Growth, run by HiPP GmbH & Co. Vertrieb KG at 1 site in Germany.
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 11 inclusion and 11 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 26 Nov 2021. 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 Germany. 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?
Infant daily weight gain (in g/day) between 30 days and 120 days of age (time frame: 90 days duration). 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 26 Nov 2021.