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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04360967
Other study ID # 14.11.INF
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 31, 2017
Est. completion date June 2, 2017

Study information

Verified date April 2020
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2, 2017
Est. primary completion date June 2, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 44 Days
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Infant, Small for Gestational Age

Intervention

Other:
Standard Formula
Standard Formula
Nutrient-enriched Formula
Nutrient-enriched Formula

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of neurodevelopment Assessed using Bayley Scales of Infant and Toddler DevelopmentĀ® - Third Edition - (To compare with the standard Bayley scores). at the baseline (2 years of age)
Primary Evaluation of length-for-age Z-score Using the WHO growth chart Evaluated once at 2 years of age
Primary Systolic Blood pressure Systolic and diastolic blood pressure measurement from 1 to 6 months of age at baseline (2 years of age)
Secondary Evaluation of insulin sensitivity HOMA-IR (Homeostatic Model Assessment - Insulin Resistance) calculated from Basal (Fasting) plasma glucose and insulin concentrations. at Baseline ( 2 years of age).
Secondary Evaluation of insulin sensitivity HOMA-IR (Homeostatic Model Assessment - Insulin Resistance) calculated from Basal (Fasting) plasma glucose and insulin concentrations. at last visit ( 5 years of age).
Secondary Neurodevelopment Assessed using Wechsler Preschool and Primary Scale of Intelligenceā„¢ - Fourth Edition (WPPSI-IV) - (to compare the scores against the standard scores). At last visit ( 5 years of age)
Secondary Safety (Adverse Event reporting) Assessed by Type, incidence, severity, seriousness and relationship to study formulas of AEs (including Infection) among the study subjects. From 1 to 6 months of age & 6 months to 5 years of age.
Secondary Growth (Length) 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). At 2 years of age
Secondary Growth (Weight) 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). At 2 years of age
Secondary Growth (Head circumference) 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). At 2 years of age
Secondary Growth (Z-Scores) 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). At 2 years of age
Secondary Evaluation of serum markers of bone metabolism Assessed by Incidence of abnormal serum (Calcium, phosphorus, Alkaline phosphatase). At visit 1 (<44 days)
Secondary Evaluation of serum markers of bone metabolism Assessed by Incidence of abnormal serum (Calcium, phosphorus, Alkaline phosphatase). At visit 4 (6 months)
Secondary Evaluation of urinary markers of bone metabolism Assessed by Incidence of urine biochemistries (calcium, phosphorous). At visit 1 (<44 days)
Secondary Evaluation of urinary markers of bone metabolism Assessed by Incidence of urine biochemistries (calcium, phosphorous). At visit 4 (6 months)
Secondary Body fat mass (%) Assessed by Deterium dilution evaluated until 5 years of age.
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