SURF, Neurodevelopment, Growth Study in SGA Infants

NCT04360967 | Withdrawn

• 1 other identifier: 14.11.INF
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infant, Small for Gestational Age

Outcome Measures

Primary Outcomes (3)

• Evaluation of neurodevelopment

  Assessed using Bayley Scales of Infant and Toddler Development® - Third Edition - (To compare with the standard Bayley scores).

  at the baseline (2 years of age)

• Evaluation of length-for-age Z-score

  Using the WHO growth chart

  Evaluated once at 2 years of age

• Systolic Blood pressure

  Systolic and diastolic blood pressure measurement from 1 to 6 months of age

  at baseline (2 years of age)

Secondary Outcomes (13)

• Evaluation of insulin sensitivity

  at Baseline ( 2 years of age).

• Evaluation of insulin sensitivity

  at last visit ( 5 years of age).

• Neurodevelopment

  At last visit ( 5 years of age)

• Safety (Adverse Event reporting)

  From 1 to 6 months of age & 6 months to 5 years of age.

• Growth (Length)

  At 2 years of age

Study Arms (4)

Randomized Standard Formula-fed

EXPERIMENTAL

Product will be given to the formula-fed groups during the intervention phase of the study (enrollment to age 6 months).

Other: Standard Formula

Randomized Nutrient-enriched formula-fed

EXPERIMENTAL

Product will be given to the formula-fed groups during the intervention phase of the study (enrollment to age 6 months).

Other: Nutrient-enriched Formula

Non-randomized HM-fed

NO INTERVENTION

Infants in HM-fed group will be fed through 6 months of age, along with micronutrient supplementation per routine clinical practice.

Non-Randomized HM-fed

NO INTERVENTION

Infants in HM-fed group will be fed through 6 months of age, along with micronutrient supplementation per routine clinical practice.

Interventions

Standard Formula OTHER

Standard Formula

Randomized Standard Formula-fed

Nutrient-enriched Formula OTHER

Nutrient-enriched Formula

Randomized Nutrient-enriched formula-fed

Eligibility Criteria

• Age: 1 Day - 44 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: April 24, 2020
• Study Start: March 31, 2017
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: April 24, 2020

Record last verified: 2020-04