SURF, Neurodevelopment, Growth Study in SGA Infants
- Conditions
- Infant, Small for Gestational Age
- Interventions
- Other: Standard FormulaOther: Nutrient-enriched Formula
- Registration Number
- NCT04360967
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Having obtained his/her parents' (or his/her legally accepted representative's LAR's]) written informed consent and having evidence of a personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of pertinent aspects of the study.
- For infants in formula fed groups only: infants who require formula feeding due to lactation failure after minimum 2 rounds of breastfeeding counselling.
- Birth Weight < 10th percentile at term using the 2013 INTERGROWTH-21st Growth Charts for girls and boys.
- Full term birth (gestational age ≥ 37 weeks and ≤ 41 weeks + 6 days), with gestational age estimated using fetal anthropometry by ultrasonography in early 1st trimester of pregnancy or calculated using the first day of the last menstrual period + 40 weeks if fetal anthropometry data for term calculation is not available or was collected after the 1st trimester.
- Age <45 days at time of enrollment
- For infants in the HM-fed AGA comparator group only: born to mothers with pre-pregnancy body mass index (BMI) ≥ 18.5 and <25kg/m2
- mothers with Type-1 Diabetes
- mothers who smoked >10 cigarettes per day during pregnancy.
- mothers who used Illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (>3 alcoholic beverages per week) during pregnancy
- Suspected or documented systemic or congenital infections (e.g Human Immunodeficiency virus, cytomegalovirus)
- Genetic or any other type of congenital malformations, metabolic, cardiovascular, gastrointestinal, pancreatic or hepatic diseases or medical conditions that could compromise growth and/or food intake.
- Fit to be discharged from neonatal intensive care unit (NICU) in > 5 consecutive days with the exception of infants in the NICU due to jaundice only.
- Known or suspected intolerance/ allergy to milk protein or any ingredient in the study formulas
- For infants in the HM-fed groups only: infants who are consuming fortified human milk or formula.
- Participation in any other interventional clinical trial during the 14 days prior to enrollment.
- Infants or infant's family who in the investigator's judgement cannot be expected to comply with the protocol or study procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Randomized Standard Formula-fed Standard Formula Product will be given to the formula-fed groups during the intervention phase of the study (enrollment to age 6 months). Randomized Nutrient-enriched formula-fed Nutrient-enriched Formula Product will be given to the formula-fed groups during the intervention phase of the study (enrollment to age 6 months).
- Primary Outcome Measures
Name Time Method Evaluation of neurodevelopment at the baseline (2 years of age) Assessed using Bayley Scales of Infant and Toddler Development® - Third Edition - (To compare with the standard Bayley scores).
Evaluation of length-for-age Z-score Evaluated once at 2 years of age Using the WHO growth chart
Systolic Blood pressure at baseline (2 years of age) Systolic and diastolic blood pressure measurement from 1 to 6 months of age
- Secondary Outcome Measures
Name Time Method Neurodevelopment At last visit ( 5 years of age) Assessed using Wechsler Preschool and Primary Scale of Intelligence™ - Fourth Edition (WPPSI-IV) - (to compare the scores against the standard scores).
Safety (Adverse Event reporting) From 1 to 6 months of age & 6 months to 5 years of age. Assessed by Type, incidence, severity, seriousness and relationship to study formulas of AEs (including Infection) among the study subjects.
Evaluation of insulin sensitivity at last visit ( 5 years of age). HOMA-IR (Homeostatic Model Assessment - Insulin Resistance) calculated from Basal (Fasting) plasma glucose and insulin concentrations.
Growth (Length) At 2 years of age 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).
Evaluation of urinary markers of bone metabolism At visit 4 (6 months) Assessed by Incidence of urine biochemistries (calcium, phosphorous).
Growth (Head circumference) At 2 years of age 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).
Growth (Weight) At 2 years of age 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).
Body fat mass (%) evaluated until 5 years of age. Assessed by Deterium dilution
Growth (Z-Scores) At 2 years of age 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).
Evaluation of serum markers of bone metabolism At visit 4 (6 months) Assessed by Incidence of abnormal serum (Calcium, phosphorus, Alkaline phosphatase).