Disturbance of GrowthHippHANCT01143233
Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up
A study testing intervention formula 1, intervention formula 2 and intervention formula 3 in people with Disturbance of Growth, run by HiPP GmbH & Co. Vertrieb KG at 5 sites in 3 countries.
Trial summary
The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants. Read more about this study
- Who is it for?
- Ages 1 day to 27 daysHealthy volunteers can take part
- Conditions the study is for
- Disturbance of Growth
- What is being tested?
- intervention formula 1, intervention formula 2 and intervention formula 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Apr 2010to Aug 2017
- 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 1 day to 27 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- written informed consent (by parents, caregiver)
- Healthy term newborns (gestational age: ≥ 37 weeks)
- Birth weight between 2.500 - 4.500 g
- Age at enrolment: < 28 days of age
- Infant received no other formula since birth
- Parents / Caregivers are able to speak German
Who cannot join
- Severe acquired or congenital illness
- preterm infants (gestational age < 37 weeks)
- Birth weight lower than 2.500 g or higher than 4.500 g
- Feeding a cows milk based formula or any other formula prior to inclusion in this study
- Participation in any other clinical study intervention
- Regular intake of supplementary pre- and probiotics by the child and/or breastfeeding mother
Show all 10Show fewer
- Mothers with diabetes mellitus or mothers suffered from gestational diabetes
- Founded assumption that it will not be possible for parents / caregivers to be compliant with the study protocol
- Breastfed infants: illness of the mother, that may have an influence on the gastrointestinal tract of the child
- Breastfed infants: mother receives or received antibiotics one week before inclusion in this study or during the first study phase
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany3 sites
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Berlin, 13353
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum
Bochum, North Rhine-Westphalia, 44791
University Hospital Rostock
Rostock, Mecklenburg-Vorpommern, 18059
Austria1 site
Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie
Vienna, 1090
About this study
Official title: Suitability of an Infant Formula With Reduced Protein Content Based on a Partial Respectively an Extensive Proteinhydrolysate With and Without Pro- and Prebiotics for the Particular Nutritional Use by Infants.-Extension by 4 Year Follow-up
The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants.
Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life.
4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.
Read the detailed description
View Section Brief Summary
- Conditions
- Disturbance of Growth
- Being tested
- control formula, intervention formula 1, intervention formula 2, intervention formula 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control formulaOther
infants are fed a commercial hydrolyzed formula
intervention formula 1Other
formula has hydrolysed protein and a different protein content
intervention formula 2Other
formula has hydrolysed protein, different protein content and pro- and prebiotics
intervention formula 3Other
formula has hydrolysed protein, different protein content and pro- and prebiotics
| Study group | Role | What they receive |
|---|---|---|
| control formula group | Active comparator | infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol Receives: Other: control formula |
| intervention formula 1 group | Experimental | infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol Receives: Other: intervention formula 1 |
| intervention formula 2 group | Experimental | infants are fed hydrolyzed infant formula with different protein content with pro- and prebiotics during the first 4 month of life, according to protocol Receives: Other: intervention formula 2 |
| intervention formula 3 group | Experimental | infants are fed hydrolyzed instant formula with different protein content with pro- and prebiotics during the first 4 months of life, according to protocol Receives: Other: intervention formula 3 |
| Reference group | No intervention | infants are breast fed |
What is being measured
The primary outcome is the main question the study is designed to answer.
average weight gain
The intervention is to assess average weight gain in the first 4 months of life.
Measured: 4 months
Secondary outcomes (5)
allergic sensitization and symptoms
blood sample to assess allergic predisposition
Measured: 12 months
Anthropometric data at age of 4 years
Weight, length and Head circumference measurements at Age of 4 years
Measured: 4 years
Body composition (Skin fold) at age of 4 years
Caliper measurement at Age of 4 years
Measured: 4 years
Body composition (fat mass, lean body mass) at age of 4 years
bioelectrical impedance Analysis at Age of 4 years
Measured: 4 years
Allergic predisposition at age of 4 years by measuring specific IgE in blood
blood sample to allergic predisposition at Age of 4 years
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2014
- Study completionAug 2017
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 Disturbance of 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Ulrich Wahn, Prof., Principal investigator, Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/ImmunologieKirsten Beyer, Prof, Principal investigator, Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143233
- Sponsor's protocol ID
- Hipp2010
- Acronym
- HippHA
- Status last verified
- Nov 2017
- First submitted
- 11 Jun 2010
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahrens B, Hellmuth C, Haiden N, Olbertz D, Hamelmann E, Vusurovic M, Fleddermann M, Roehle R, Knoll A, Koletzko B, Wahn U, Beyer K. Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth: A Randomized Controlled Noninferiority Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):822-830. doi: 10.1097/MPG.0000000000001853.
PubMed 29216020
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suitability of an Infant Formula With Reduced Protein Content Based on a Partial Respectively an Extensive Proteinhydrolysate With and Without Pro- and Prebiotics for the Particular Nutritional Use by Infants.-Extension by 4 Year Follow-up
- ClinicalTrials.gov ID
- NCT01143233
- Acronym / sponsor ID
- HippHA / Hipp2010
- Conditions
- Disturbance of Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KGIndustry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Study start
- Apr 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 14 Jun 2010 (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.
The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants.
Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life.
4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.
Detailed description
View Section Brief Summary
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| control formula group | Active comparator | Other: control formulainfants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol |
| intervention formula 1 group | Experimental | Other: intervention formula 1infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol |
| intervention formula 2 group | Experimental | Other: intervention formula 2infants are fed hydrolyzed infant formula with different protein content with pro- and prebiotics during the first 4 month of life, according to protocol |
| intervention formula 3 group | Experimental | Other: intervention formula 3infants are fed hydrolyzed instant formula with different protein content with pro- and prebiotics during the first 4 months of life, according to protocol |
| Reference group | No intervention | –infants are breast fed |
Who may qualify
- Ages
- 1 day to 27 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- written informed consent (by parents, caregiver)
- Healthy term newborns (gestational age: ≥ 37 weeks)
- Birth weight between 2.500 - 4.500 g
- Age at enrolment: < 28 days of age
- Infant received no other formula since birth
Key exclusion criteria (10 listed)
- Severe acquired or congenital illness
- preterm infants (gestational age < 37 weeks)
- Birth weight lower than 2.500 g or higher than 4.500 g
- Feeding a cows milk based formula or any other formula prior to inclusion in this study
- Participation in any other clinical study intervention
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 |
|---|---|---|
| control formulainfants are fed a commercial hydrolyzed formula | Other | control formula group |
| intervention formula 1formula has hydrolysed protein and a different protein content | Other | intervention formula 1 group |
| intervention formula 2formula has hydrolysed protein, different protein content and pro- and prebiotics | Other | intervention formula 2 group |
| intervention formula 3formula has hydrolysed protein, different protein content and pro- and prebiotics | Other | intervention formula 3 group |
Primary outcome
average weight gain
Time frame: 4 months
The intervention is to assess average weight gain in the first 4 months of life.
5 secondary outcomes
allergic sensitization and symptoms
Time frame: 12 months
Anthropometric data at age of 4 years
Time frame: 4 years
Body composition (Skin fold) at age of 4 years
Time frame: 4 years
Body composition (fat mass, lean body mass) at age of 4 years
Time frame: 4 years
Allergic predisposition at age of 4 years by measuring specific IgE in blood
Time frame: 4 years
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 30 Nov 2017.
- Derived from this study: PubMed 29216020Ahrens B, Hellmuth C, Haiden N, Olbertz D, Hamelmann E, Vusurovic M, Fleddermann M, Roehle R, Knoll A, Koletzko B, Wahn U, Beyer K. Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth: A Randomized Controlled Noninferiority Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):822-830. doi: 10.1097/MPG.0000000000001853.
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.
Ulrich Wahn, Prof. principal investigator
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Kirsten Beyer, Prof principal investigator
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention formula 1, intervention formula 2 and intervention formula 3 in people with Disturbance of Growth, run by HiPP GmbH & Co. Vertrieb KG at 5 sites in 3 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 6 inclusion and 10 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 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Austria, Serbia. 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?
average weight gain (time frame: 4 months). 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 NCT01143233, 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 30 Nov 2017.