Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT07231705
Eligibility Criteria:
Inclusion Criteria:
* Children, male or female, aged 12 through 17 months (for premature infants, we will use corrected age)
* Children with a weight-for-length z score between ≥ -1.5 at enrolment
* Children obtaining via formula feeding ≥ 80% of their total energy intake at enrolment and expected to continue to require such formula intake for the next 24 weeks
* Children from families who are willing and able to comply with the requirements of the protocol
* Written informed consent from the parent or legal guardian
* Parent/caregiver or legal guardian must be able to read, write, and understand English
Exclusion Criteria:
* Children with known or suspected complex gastrointestinal anomalies or dysfunction, hepatic or renal dysfunction, or inherited metabolic disorders, suspected or diagnosed conditions associated with malabsorption (e.g. cystic fibrosis) (Note: For hepatic dysfunction, a conjugated bilirubin \>2.0 mg/dL and for renal dysfunction child should not meet any of the Pediatric Risk, Injury, Failure, Loss, End Stage Renal Disease (pRIFLE) criteria for renal disease (estimated creatinine clearance decreased by 25% by the Schwartz formula or urine output \<0.5 mL/kg per hour over the previous 8 or more hours) or has chronic medical renal disease. We will not obtain labs to exclude children. If children are noted to have liver disease or renal disease in their chart, we will look at their labs to ensure that they do not meet exclusion criteria).
* Children with tracheostomy and/or inspired oxygen via nasal cannula or children receiving diuretics.
* Children with known or suspected genetic and/or metabolic inborn errors of metabolism conditions known to interfere with growth or body dysmorphology that can interfere with obtaining standard anthropometric measurements (weight, length, head circumference, and arm circumference)
* At study entry, children expected to consume on average more than 20% of their energy intake from non-formula sources of nutrition: solids, expressed breast milk and /or parenteral nutrition.
* Child requiring or expected to have an energy requirement \< 80 kcal/kg per day - Breastfeeding child (who is feeding at the breast \> 2 times per day)
* Child likely to undergo major surgery during the duration of the study
* Child with a nasogastric tube that is unlikely to get a gastrostomy tube during the duration of the study
* Principal Investigator's uncertainty about the willingness or ability of the parent/caregiver to comply with the protocol requirements
* Children whose parent is younger than the legal age of consent
* Children with known allergy to pea protein or soy or peanuts.
* Children with a parent or a sibling with a known allergy to pea protein or soy or peanuts.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
17 Months
Study:
NCT07231705
Study Brief:
Protocol Section:
NCT07231705