Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-12
SponsorDutch Medical Food
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Infant Formula
Other interventionProspective, 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.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: InterventionalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Body Weight
Body Weight
Time frame
8 weeks2
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: