Clinical trial NCT04360967: SURF, Neurodevelopment, Growth Study in SGA Infants
Official title: Neurodevelopment, Growth, and Metabolic Syndrome Biomarkers in Term Small-for-gestational-age Infants Fed Standard or Nutrient-enriched Formula
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infant, Small for Gestational Age
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. For infants in formula fed groups only: infants who require formula feeding due to lactation failure after minimum 2 rounds of breastfeeding counselling.
3. Birth Weight \< 10th percentile at term using the 2013 INTERGROWTH-21st Growth Charts for girls and boys.
4. 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.
5. Age \<45 days at time of enrollment
6. 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:

1. mothers with Type-1 Diabetes
2. mothers who smoked \>10 cigarettes per day during pregnancy.
3. mothers who used Illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\>3 alcoholic beverages per week) during pregnancy
4. Suspected or documented systemic or congenital infections (e.g Human Immunodeficiency virus, cytomegalovirus)
5. 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.
6. 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.
7. Known or suspected intolerance/ allergy to milk protein or any ingredient in the study formulas
8. For infants in the HM-fed groups only: infants who are consuming fortified human milk or formula.
9. Participation in any other interventional clinical trial during the 14 days prior to enrollment.
10. Infants or infant's family who in the investigator's judgement cannot be expected to comply with the protocol or study procedures.

Primary outcomes:
measure: Evaluation of neurodevelopment
timeFrame: at the baseline (2 years of age)
measure: Evaluation of length-for-age Z-score
timeFrame: Evaluated once at 2 years of age
measure: Systolic Blood pressure
timeFrame: at baseline (2 years of age)
Secondary outcomes:
measure: Evaluation of insulin sensitivity
timeFrame: at Baseline ( 2 years of age).
measure: Evaluation of insulin sensitivity
timeFrame: at last visit ( 5 years of age).
measure: Neurodevelopment
timeFrame: At last visit ( 5 years of age)
measure: Safety (Adverse Event reporting)
timeFrame: From 1 to 6 months of age & 6 months to 5 years of age.
measure: Growth (Length)
timeFrame: At 2 years of age
measure: Growth (Weight)
timeFrame: At 2 years of age
measure: Growth (Head circumference)
timeFrame: At 2 years of age
measure: Growth (Z-Scores)
timeFrame: At 2 years of age
measure: Evaluation of serum markers of bone metabolism
timeFrame: At visit 1 (<44 days)
measure: Evaluation of serum markers of bone metabolism
timeFrame: At visit 4 (6 months)
measure: Evaluation of urinary markers of bone metabolism
timeFrame: At visit 1 (<44 days)
measure: Evaluation of urinary markers of bone metabolism
timeFrame: At visit 4 (6 months)
measure: Body fat mass (%)
timeFrame: evaluated until 5 years of age.
Other outcomes:
Locations:
Study officials:
References: