SURF, Neurodevelopment, Growth Study in SGA Infants (NCT04360967) | Clinical Trial Compass
WithdrawnNot Applicable
SURF, Neurodevelopment, Growth Study in SGA Infants
Stopped: Sponsor decision stopped in June 2017
0Started 2017-03-31
Plain-language 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.
Who can participate
Age range1 Day – 44 Days
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.