The purpose of this study is to determine whether term SGA infants who are fed a nutrient-enriched pre-term formula will have a higher cognitive score, a more appropriate length-for-age Z-score (leading to a lower prevalence of Stunting) but higher blood pressure at 2 years of age compared to term SGA infants who are fed on a regular starter formula.
This is multi-sites, interventional, double-blinded, randomized, 2-arm parallel-group clinical trial. Two HM fed groups will be included as comparator group. The primary objectives are: 1. To evaluate neurodevelopment at 2 years of age in term small-for-gestational age (SGA) infants fed standard formula or nutrient-enriched formula from 1 to 6 months of age and compare to each human milk (HM)-fed group. 2. To evaluate length-for-age Z-score at 2 years of age in term SGA infants fed standard formula or nutrient-enriched formula from 1 to 6 months of age and compare to each HM-fed group. 3. To evaluate systolic blood pressure at 2 years of age in term SGA infants fed standard formula or nutrient-enriched formula from 1 to 6 months of age and compare to each HM-fed group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Standard Formula
Nutrient-enriched Formula
Evaluation of neurodevelopment
Assessed using Bayley Scales of Infant and Toddler Development® - Third Edition - (To compare with the standard Bayley scores).
Time frame: at the baseline (2 years of age)
Evaluation of length-for-age Z-score
Using the WHO growth chart
Time frame: Evaluated once at 2 years of age
Systolic Blood pressure
Systolic and diastolic blood pressure measurement from 1 to 6 months of age
Time frame: at baseline (2 years of age)
Evaluation of insulin sensitivity
HOMA-IR (Homeostatic Model Assessment - Insulin Resistance) calculated from Basal (Fasting) plasma glucose and insulin concentrations.
Time frame: at Baseline ( 2 years of age).
Evaluation of insulin sensitivity
HOMA-IR (Homeostatic Model Assessment - Insulin Resistance) calculated from Basal (Fasting) plasma glucose and insulin concentrations.
Time frame: at last visit ( 5 years of age).
Neurodevelopment
Assessed using Wechsler Preschool and Primary Scale of Intelligence™ - Fourth Edition (WPPSI-IV) - (to compare the scores against the standard scores).
Time frame: At last visit ( 5 years of age)
Safety (Adverse Event reporting)
Assessed by Type, incidence, severity, seriousness and relationship to study formulas of AEs (including Infection) among the study subjects.
Time frame: From 1 to 6 months of age & 6 months to 5 years of age.
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Growth (Length)
Evaluation of length-for-age in each formula-fed group by Percentages of study population with length-for-age Z-score less than 2.5th, 5th and 10th Percentile on the WHO reference curve(\<2.5th percentile indicating prevalence of stunting).
Time frame: At 2 years of age
Growth (Weight)
Evaluation of weight-for-age in each formula-fed group by Percentages of study population with length-for-age Z-score less than 2.5th, 5th and 10th Percentile on the WHO reference curve(\<2.5th percentile indicating prevalence of stunting).
Time frame: At 2 years of age
Growth (Head circumference)
Evaluation of head circumference-for-age in each formula-fed group by Percentages of study population with length-for-age Z-score less than 2.5th, 5th and 10th Percentile on the WHO reference curve(\<2.5th percentile indicating prevalence of stunting).
Time frame: At 2 years of age
Growth (Z-Scores)
Evaluation of weight-for-length Z-scores in each formula-fed group by Percentages of study population with length-for-age Z-score less than 2.5th, 5th and 10th Percentile on the WHO reference curve(\<2.5th percentile indicating prevalence of stunting).
Time frame: At 2 years of age
Evaluation of serum markers of bone metabolism
Assessed by Incidence of abnormal serum (Calcium, phosphorus, Alkaline phosphatase).
Time frame: At visit 1 (<44 days)
Evaluation of serum markers of bone metabolism
Assessed by Incidence of abnormal serum (Calcium, phosphorus, Alkaline phosphatase).
Time frame: At visit 4 (6 months)
Evaluation of urinary markers of bone metabolism
Assessed by Incidence of urine biochemistries (calcium, phosphorous).
Time frame: At visit 1 (<44 days)
Evaluation of urinary markers of bone metabolism
Assessed by Incidence of urine biochemistries (calcium, phosphorous).
Time frame: At visit 4 (6 months)
Body fat mass (%)
Assessed by Deterium dilution
Time frame: evaluated until 5 years of age.