Growth Clinical Trial
Official title:
Study of Nutritional Suitability of a New Infant Formula for Term Infants
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 |
Verified date | November 2018 |
Source | Ausnutria Hyproca B.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ausnutria Hyproca B.V. |
Austria, Croatia, Germany, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight gain | 16 weeks |
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