SURF, Neurodevelopment, Growth Study in SGA Infants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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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.
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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.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Randomized Standard Formula-fed Product will be given to the formula-fed groups during the intervention phase of the study (enrollment to age 6 months). |
Other: Standard Formula
Standard Formula
|
| Experimental: Randomized Nutrient-enriched formula-fed Product will be given to the formula-fed groups during the intervention phase of the study (enrollment to age 6 months). |
Other: Nutrient-enriched Formula
Nutrient-enriched Formula
|
| No Intervention: Non-randomized HM-fed Infants in HM-fed group will be fed through 6 months of age, along with micronutrient supplementation per routine clinical practice. |
|
| No Intervention: Non-Randomized HM-fed Infants in HM-fed group will be fed through 6 months of age, along with micronutrient supplementation per routine clinical practice. |
Outcome Measures
Primary Outcome Measures
- 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
- Evaluation of insulin sensitivity [at Baseline ( 2 years of age).]
HOMA-IR (Homeostatic Model Assessment - Insulin Resistance) calculated from Basal (Fasting) plasma glucose and insulin concentrations.
- 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.
- 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.
- 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).
- 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).
- 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 (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 1 (<44 days)]
Assessed by Incidence of abnormal serum (Calcium, phosphorus, Alkaline phosphatase).
- Evaluation of serum markers of bone metabolism [At visit 4 (6 months)]
Assessed by Incidence of abnormal serum (Calcium, phosphorus, Alkaline phosphatase).
- Evaluation of urinary markers of bone metabolism [At visit 1 (<44 days)]
Assessed by Incidence of urine biochemistries (calcium, phosphorous).
- Evaluation of urinary markers of bone metabolism [At visit 4 (6 months)]
Assessed by Incidence of urine biochemistries (calcium, phosphorous).
- Body fat mass (%) [evaluated until 5 years of age.]
Assessed by Deterium dilution
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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For infants in formula fed groups only: infants who require formula feeding due to lactation failure after minimum 2 rounds of breastfeeding counselling.
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Birth Weight < 10th percentile at term using the 2013 INTERGROWTH-21st Growth Charts for girls and boys.
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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.
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Age <45 days at time of enrollment
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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
Exclusion Criteria:
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mothers with Type-1 Diabetes
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mothers who smoked >10 cigarettes per day during pregnancy.
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mothers who used Illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (>3 alcoholic beverages per week) during pregnancy
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Suspected or documented systemic or congenital infections (e.g Human Immunodeficiency virus, cytomegalovirus)
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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.
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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.
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Known or suspected intolerance/ allergy to milk protein or any ingredient in the study formulas
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For infants in the HM-fed groups only: infants who are consuming fortified human milk or formula.
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Participation in any other interventional clinical trial during the 14 days prior to enrollment.
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Infants or infant's family who in the investigator's judgement cannot be expected to comply with the protocol or study procedures.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nestlé
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14.11.INF