Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up (HippHA)

HiPP

Status: Completed

Conditions: Disturbance of Growth

Treatments: Other: intervention formula 3; Other: intervention formula 1; Other: control formula; Other: intervention formula 2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01143233

Hipp2010

Details and patient eligibility

About

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.

Full description

View Section Brief Summary

Enrollment: 503 patients

Sex: All

Ages: 1 to 27 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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503 participants in 5 patient groups

control formula group

Active Comparator group

Description:

infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol

Treatment:

Other: control formula

intervention formula 1 group

Experimental group

Description:

infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol

Treatment:

Other: intervention formula 1

intervention formula 2 group

Experimental group

Description:

infants are fed hydrolyzed infant formula with different protein content with pro- and prebiotics during the first 4 month of life, according to protocol

Treatment:

Other: intervention formula 2

intervention formula 3 group

Experimental group

Description:

infants are fed hydrolyzed instant formula with different protein content with pro- and prebiotics during the first 4 months of life, according to protocol

Treatment:

Other: intervention formula 3

Reference group

No Intervention group

Description:

infants are breast fed