Leveraging Optimal Tolerance in Undernourished Infants to Support Growth

Starting soon · Not applicable

Conditions studied: Faltering Growth, Failure to Thrive

In brief

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.

Key facts

Study ID

NCT07549360

Run by

Dutch Medical Food

People needed

35

Starts

2026-05-15

Expected to finish

2027-05-15

Last updated by the study team

2026-04-24

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Pediatrics, Faculty of Medicine, Chulalongkorn University — Bangkok, Bangkok, Thailand

Full record on ClinicalTrials.gov

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