Leveraging Optimal Tolerance in Undernourished Infants to Support Growth (NCT07549360) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
Thailand35 participantsStarted 2026-05-15
Plain-language summary
The goal of this study is to learn if InfaCore (IC) an energy and nutrient dense formulation (ENDF) can improve growth and tolerance in infants with or at risk of growth faltering when fed IC.
Who can participate
Age range1 Month – 12 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Infants aged from 1 month to \</=12 months of age
* Infants taking at least 50% of daily intake from infant formula
* Diagnosis of FG (a fall in WAZ of ≥1.0 SD over 1 month or more - not including the first 2 weeks after birth) or risk of FG (static weight for \>/= 1 month)
* Infants \>/=37 weeks gestation at time of recruitment
* Parent/ legal guardian willing to provide written informed consent
Exclusion Criteria:
* Exclusively Breastfed infants
* Infants with other medical problems that might independently affect intake (oral or otherwise) or who have specific nutrient needs not met by IC e.g. some gastrointestinal malformations, some renal and liver conditions, inborn errors of metabolism, galactosemia
* Infants on total parenteral nutrition
* Infants with cow milk protein allergy
* Infants with soy allergy
* Infants who participated in other studies within 2 weeks prior to recruitment
* Situations where the investigator has concerns about the willingness or ability of the parents/caregivers to comply with protocol requirements
* Infants who are on a vegan diet
* Infants who are allergic to fish
* Infants born preterm \<37 weeks gestation