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NCT02490852 Clinical Trial

Study of Nutritional Suitability of a New Infant Formula for Term Infants

Growth Clinical Trial

Official title:
Study of Nutritional Suitability of a New Infant Formula for Term Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02490852
Other study ID # AUS/015513
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date August 22, 2018

Study information
Verified date November 2018
Source Ausnutria Hyproca B.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.

Recruitment information / eligibility
Status Completed
Enrollment 304
Est. completion date August 22, 2018
Est. primary completion date August 22, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 13 Days
Eligibility Inclusion Criteria:

- Healthy full term infant (37-42 weeks of gestational age)

- Birth weight 2,500 to 4,500 g

- Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation

- Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary

- Informed consent signed by parent(s)/caregiver(s)

Exclusion Criteria:

- Congenital illness or malformation that may affect infant feeding or normal growth

- Gastrointestinal disorders

- Suspected or known allergy to milk protein for formula groups

- Known food allergies in parents or siblings for formula groups

- Multiples

- Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrollment

- Infant participating in another clinical study

- Infant's family unable to comply with the protocol according to the investigators's assessment

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Investigational infant formula
fed ad libitum
• Active Comparator: Commercially available Infant formula
fed ad libitum
• Active Comparator: Human milk
fed ad libitum

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ausnutria Hyproca B.V.

Countries where clinical trial is conducted

Austria,  Croatia,  Germany,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight gain 16 weeks
See also
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