Safety of an Infant Formula With Hydrolysed Protein in Term Infants

NCT04736082 | Completed DMC

• 1 other identifier: 508917-2
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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 days of life with an optional follow up until 180 days of life.

Conditions

Growth

Keywords

Safety; Growth; Weight Gain; Infant Formula; Infants

Outcome Measures

Primary Outcomes (1)

• Infant daily weight gain (in g/day) between 30 days and 120 days of age

  90 days duration

Study Arms (3)

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.

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.

Other: Control Group: Infant Formula with intact protein

Breast Fed Group

NO INTERVENTION

Exclusively breast milk

Interventions

Intervention Group: Infant Formula with hydrolyzed protein OTHER

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).

Intervention Group: Infant Formula with hydrolyzed protein

Control Group: Infant Formula with intact protein OTHER

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).

Control Group: Infant Formula with intact protein

Eligibility Criteria

• Age: 0 Days - 25 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HiPP GmbH & Co. Vertrieb KG: lead
• Waldkrankenhaus Protestant Hospital, Spandau: collaborator
• Biofortis, Merieux NutriSciences: collaborator
• HungaroTrial: collaborator

Study Sites (1)

Evangelisches Waldkrankenhaus Spandau

Berlin, 13589, Germany

Location

MeSH Terms

Conditions

Weight Gain

Interventions

Protein Hydrolysates

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Frank Jochum, PD Dr. med.

  Evangelisches Waldkrankenhaus Spandau, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: March 16, 2021
• Primary Completion: August 31, 2021
• Study Completion: October 27, 2021
• Last Updated: November 26, 2021

Record last verified: 2021-11

Locations

DE (1)