Status:
WITHDRAWN
SURF, Neurodevelopment, Growth Study in SGA Infants
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Infant, Small for Gestational Age
Eligibility:
All Genders
1-44 years
Phase:
NA
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 (leadi...
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 evalua...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04360967
Start Date
March 31 2017
End Date
June 2 2017
Last Update
April 24 2020
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