The purpose of this prospective study is to evaluate the growth and enteral tolerance of two pea protein-based formulas from Kate Farms in children aged 12 to 17 months who are expected to meet most of their nutritional needs through formula. It is hypothesized that the Pediatric Standard 1.2 and Pediatric Peptide 1.0 formulas will support healthy growth in children between 1 and 2 years of age. The study will assess the impact of these formulas on growth, tolerance, body composition, micronutrient levels, and gut microbiome health in tube-fed children. Formula will be provided for 24 weeks.
This is a prospective cohort study. Forty children ages 12-17 months who rely on formula for at least 80% of their nutritional needs (by mouth of tube feeding) are expected to continue this dependence for the next 6 months will be recruited. Children will be recruited from the Feeding Program, GI clinic and Complex Care clinic at Nationwide Children's Hospital in Columbus, Ohio. The study will be introduced to the patient by the provider during a routine clinic visit. Parent consent will be obtained from one of the research investigators during the clinic visit. The objectives are to study the effect of these formulas on the functions of the body (AND NOT to evaluate its role in any disease state) in the form of growth and nutrition status. \- To sustain/improve to a weight-for-length z-score of between -1 and 0 up through 24 weeks, in children who are predominantly receiving nutrition via formula (either orally or via tube feeding) Secondary study objectives: * To sustain other anthropometric measurements * To assess tolerance * To assess changes in body composition and gut microbiome * To assess changes in key micronutrients. To sustain the following z scores up through 24 weeks relative to baseline: * Weight-for-age * Length-for-age * Head circumference-for-age * Mid upper arm circumference (MUAC)-for-age * Weight velocity * Length velocity o When ex-preterm infants are recruited, all of these measures will be corrected for gestational age. Tolerance: Composite measure of tolerance using 3-day diaries: * Percentage of feedings that result in spit up/vomiting * Average number of stools/day * Average stool consistency score using the Brussels Infant and Toddler stool scale * Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infant and Toddlers Body composition: Bioelectrical impedance analysis Gut microbiome: Stool microbiome analysis Micronutrient analysis: Iron and zinc nutriture
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Kate Farms Standard 1.2 or Peptide 1.0 formulas will be provided by mouth or via tubefeeding. Study children will be fed the formula for a period of up through 24 weeks.
Nationwide Children's Hospital
Columbus, Ohio, United States
RECRUITINGWeight-for-length z-score
To sustain/improve to a weight-for-length z-score of between -1 and 0 up through 24 weeks, in children who are predominantly receiving nutrition via formula (either orally or via tube feeding)
Time frame: 24 weeks
Weight-for-age
Z-scores for weight-for-age of between -1 and 0 up through 24 weeks relative to baseline.
Time frame: 24 weeks
Length-for-age
Z scores for length-for-age of between -1 and 0 up through 24 weeks relative to baseline.
Time frame: 24 weeks
Head circumference-for-age
Z-scores for head circumference-for-age of between -1 and 0 up through 24 weeks relative to baseline.
Time frame: 24 weeks
Mid upper arm circumference (MUAC)-for-age
Z-scores for mid upper arm circumference (MUAC)-for-age of between -1 and 0 up through 24 weeks relative to baseline.
Time frame: 24 weeks
Weight velocity
Average weight velocity in grams (g)
Time frame: 24 weeks
Length velocity
Average length velocity in centimeters (cm)
Time frame: 24 weeks
Tolerance - Spit up/vomiting
Percentage of feedings that results in spit up/vomiting based on 3-day food diaries
Time frame: 24 weeks
Tolerance - Stool
Average number of stools per day
Time frame: 24 weeks
Tolerance - Stool consistency
Average stool consistency using the Brussels Infant and Toddler Stool Scale
Time frame: 24 weeks
Gastrointestinal (GI) and gastroesophageal (GER) reflux symptoms
GI and GER symptoms using the Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddler
Time frame: 24 weeks
Body Composition
Body composition parameters using a bioelectrical impedance analysis
Time frame: 24 weeks
Gut Microbiome
Stool microbiome analysis
Time frame: 24 weeks
Micronutrient analysis
Iron and zinc nutriture
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.