An interventional study of Infant Formula in Faltering Growth and Failure to Thrive, sponsored by Dutch Medical Food. Not yet recruiting at 1 site in Thailand. Open to participants aged 1 Month to 12 Months. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Dutch Medical Food · Not applicable, Interventional, and Treatment
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.
Rationale: The definition of FG/FTT was established by a group of experts in a report published in 2023 (Cooke et al., 2023). In this report they agreed a fall in weight-for-age z-score (WAZ) of ≥1.0 SD over a period of 1 or more months (excluding the first 2 weeks after birth) which includes at least 2-3 growth measurements (Cooke et al., 2023). It is also important to consider infants at risk who have static weight for extended periods e.g., >/=4 weeks. FG/FTT affects different populations and is estimated to be 10% of infants globally.
InfaCore (IC) an energy and nutrient dense formulation is indicated for infants and young children with FG/FTT defined above or for those at risk of developing e.g., with static weight for extended periods. At risk infants might include some or all of the following those with congenital heart disease (CHD) admitted for surgical procedures, those with critical illness (CI) or on the PICU, infants cystic fibrosis (CF) or other respiratory conditions including chronic lung disease (CLD), some forms of severe cerebral palsy (CP), and those requiring a surgical procedure or post-surgery.
Objective: To demonstrate growth and tolerance in infants with or at risk of growth faltering when fed IC an Energy and Nutrient Dense Formula (ENDF).
Study design: A prospective, single-centre, single-arm open label pilot study to show growth and tolerance in infants with/at risk of FG/FTT when fed an ENDF for 8 weeks.
84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.
This study's planned enrollment of 35 is below the median of 100 across 56 interventional studies indexed under Failure to Thrive.
Browse Failure to Thrive studies →This is the only study on the registry with Dutch Medical Food as lead sponsor.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Infant Formula
Prospective, single-center, single-arm open label pilot study to show growth and tolerance in infants with/at risk of FG/FTT when fed an ENDF for 8 weeks.
Also known as: Energy and Nutrient Dense Infant Formula (ENDF)
Body Weight
Body Weight
Time frame: 8 weeks
Change in body weight
The primary outcome is the change in weight-for-age Z-score from baseline to study completion, regardless of whether the value increases or decreases.
Time frame: 8 weeks
Plan to share: Undecided
Start is estimated for May 2026; primary completion for May 2026, 0 months later.
Of 18 interventional studies with no phase under Failure to Thrive, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's planned 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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