Status:
UNKNOWN
Effect of a New Infant Formula With Specific Ingredients
Lead Sponsor:
Laboratorios Ordesa
Collaborating Sponsors:
Universidad de Granada
Conditions:
Infant Growth
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of ...
Detailed Description
Nowadays, almost all commercial infant formulas resemble the "gold standard" of breast milk in terms of composition of essential nutrients, but it is still a challenge to identify and incorporate cert...
Eligibility Criteria
Inclusion
- Inclusion age from 0 to 2.5 months of age.
- Gestational age \>37 weeks and \<41 weeks inclusive.
- Appropriate birth weight appropriate for your gestational age (between 10-90 percentiles).
- APGAR score normal birth to 1' and 5' of 7 - 10.
- Umbilical pH ≥ 7.10.
- Availability to continue throughout the study period.
- Written informed consent
- Additional Inclusion Criteria for groups 1 and 2:
- Infants who, at the time of recruitment, have already passed the diet with a majority or exclusive formula for medical reasons, by decision of the parents or any other reason agreed with the pediatrician.
- Additional Inclusion Criteria for group 3 (breastfeed infants):
- Infants who have been breastfed until the second month with exclusive or majority breastfeeding.
- Infants who are expected to be exclusively or predominantly breastfed up to 6 months.
Exclusion
- Simultaneous participation in other clinical trials.
- Infants suffering from gastrointestinal disorders (allergy and/or intolerance to cow's milk protein or lactose).
- Mother's pathology history and during gestation: neurological diseases, metabolic disorders, type 1 diabetes mellitus, chronic disease (hypothyroidism), maternal malnutrition, TORCH syndrome.
- Treatment of the mother's anxiolytics or antidepressants. Other treatments with drugs potentially harmful to neurodevelopment.
- Inability of the parents to follow up the study (medical decision).
Key Trial Info
Start Date :
March 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT04306263
Start Date
March 2 2020
End Date
September 1 2022
Last Update
December 17 2020
Active Locations (1)
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1
Cristina Campoy
Granada, Andalusia, Spain, 18016