Bottle Feeding
Conditions
Brief summary
* The primary objective of the study was to compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of infants randomized to receive either standard formula, or 1 of 2 innovative formulas containing a new fat blend or the new fat blend plus fiber. * The secondary objectives were to evaluate among the feeding groups, stool characteristics (stool consistency and frequency), GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and urinary markers (F2-isoprostanes and 8-hydroxy-2'-deoxyguanosine \[8-OHdG\], and urine osmolality and specific gravity). * The primary safety objective was to describe the frequency of adverse events (AEs) among the formula-fed (FF) groups. * The secondary safety objective was to describe anthropometric measures (weight, length, and head circumference) among the feeding groups.
Interventions
DIETARY_SUPPLEMENTInfant formula
Infant formula
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Days to 45 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy, term (no less than 37 weeks and no greater than 42 weeks) singleton infants; between 25 days to 45 days post natal age (date of birth = Day 0) and weight for age ≥3rd and ≤97th percentiles according to Taiwan growth charts at the time of study entry. * Human milk fed infants were exclusively consuming and tolerating HM and the mother must have made the decision to continue to exclusively breastfeed. * Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula and parents/LAR must have previously made the decision to continue to exclusively formula feed.
Exclusion criteria
* Infants receiving any amount of supplemental HM with infant formula feeding or vice versa * Family history of siblings with documented cow's milk protein intolerance/allergy * Major congenital malformations, suspected or documented systemic or congenital infections, evidence systemic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool Composition | Day 28 | Stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool Consistency determined using a 3-day stool diary | Days 14 and 28 | Stool consistency data is collected using a 3-day stool diary completed by parents just prior to the Day 14 and Day 28 clinic visits. Average stool consistency scores are recorded on a validated 5-point scale (1 = Watery, 2 = Runny, 3 = Mushy Soft, 4 = Formed, 5 = Hard). |
| Stool frequency determined using a 3-day stool diary | Day 14 and 28 | Stool frequency data is collected using a 3-day stool diary completed by parents just prior to the Day 14 and Day 28 clinic visits. The average number of stools per day is determined for each consecutive 3-day period. |
| GI Tolerance | Baseline, Day 14 and Day 28 | GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) |
| Incidence of adverse events | From ICF signing until 14 days after last study feeding | — |
| Anthropometric measurements | Baseline, Day 14 and Day 28 | The anthropometry measurements will be determined by feeding group and by study visit. |
| Anthropometric measurements (z-scores) | Baseline, Day 14 and Day 28 | The z-scores will be determined by feeding group and by study visit. |
| Urine osmolality | Baseline and Day 28 | Measure of hydration status |
| Urine pH | Baseline and Day 28 | Measure of hydration status |
Countries
Taiwan
Outcome results
None listed