SURF, Neurodevelopment, Growth Study in SGA Infants

NCT ID: NCT04360967

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2017-06-02

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.

Conditions

Infant, Small for Gestational Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Standard Formula

Intervention Type: OTHER

Standard Formula

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).

Group Type: EXPERIMENTAL

Nutrient-enriched Formula

Intervention Type: OTHER

Nutrient-enriched Formula

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Standard Formula

Standard Formula

Intervention Type: OTHER

Nutrient-enriched Formula

Nutrient-enriched Formula

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 44 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

14.11.INF

Identifier Type: -

Identifier Source: org_study_id