- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04736082
Safety of an Infant Formula With Hydrolysed Protein in Term Infants (HASI)
November 24, 2021 updated by: HiPP GmbH & Co. Vertrieb KG
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
360
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 13589
- Evangelisches Waldkrankenhaus Spandau
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 3 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group: Infant Formula with hydrolyzed protein
Infants will receive the following infant formula: Infant formula manufactured from extensively hydrolyzed proteins and containing pre- and probiotics.
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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).
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Active Comparator: Control Group: Infant Formula with intact protein
Infants will receive the following infant formula: Infant formula manufactured from intact proteins and containing pre- and probiotics.
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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).
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No Intervention: Breast Fed Group
Exclusively breast milk
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infant daily weight gain (in g/day) between 30 days and 120 days of age
Time Frame: 90 days duration
|
90 days duration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Frank Jochum, PD Dr. med., Evangelisches Waldkrankenhaus Spandau, Berlin, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 16, 2021
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
October 27, 2021
Study Registration Dates
First Submitted
January 29, 2021
First Submitted That Met QC Criteria
January 29, 2021
First Posted (Actual)
February 3, 2021
Study Record Updates
Last Update Posted (Actual)
November 26, 2021
Last Update Submitted That Met QC Criteria
November 24, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 508917-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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