Infant, Small for Gestational AgeNCT04360967
SURF, Neurodevelopment, Growth Study in SGA Infants
A study testing Standard Formula and Nutrient-enriched Formula in people with Infant, Small for Gestational Age, run by Société des Produits Nestlé (SPN).
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… Read more about this study
- Who is it for?
- Ages 1 day to 44 daysHealthy volunteers can take part
- Conditions the study is for
- Infant, Small for Gestational Age
- What is being tested?
- Standard Formula and Nutrient-enriched Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2017to 2 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 44 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
Official title: Neurodevelopment, Growth, and Metabolic Syndrome Biomarkers in Term Small-for-gestational-age Infants Fed Standard or Nutrient-enriched Formula
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.
Read the 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:
- 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.
- 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.
- 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
- Being tested
- Standard Formula, Nutrient-enriched Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard FormulaOther
Standard Formula
Nutrient-enriched FormulaOther
Nutrient-enriched Formula
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of neurodevelopment
Assessed using Bayley Scales of Infant and Toddler Development® - Third Edition - (To compare with the standard Bayley scores).
Measured: at the baseline (2 years of age)
Evaluation of length-for-age Z-score
Using the WHO growth chart
Measured: Evaluated once at 2 years of age
Systolic Blood pressure
Systolic and diastolic blood pressure measurement from 1 to 6 months of age
Measured: at baseline (2 years of age)
Secondary outcomes (13)
Evaluation of insulin sensitivity
HOMA-IR (Homeostatic Model Assessment - Insulin Resistance) calculated from Basal (Fasting) plasma glucose and insulin concentrations.
Measured: at Baseline ( 2 years of age).
Evaluation of insulin sensitivity
HOMA-IR (Homeostatic Model Assessment - Insulin Resistance) calculated from Basal (Fasting) plasma glucose and insulin concentrations.
Measured: at last visit ( 5 years of age).
Neurodevelopment
Assessed using Wechsler Preschool and Primary Scale of Intelligence™ - Fourth Edition (WPPSI-IV) - (to compare the scores against the standard scores).
Measured: At last visit ( 5 years of age)
Safety (Adverse Event reporting)
Assessed by Type, incidence, severity, seriousness and relationship to study formulas of AEs (including Infection) among the study subjects.
Measured: From 1 to 6 months of age & 6 months to 5 years of age.
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).
Measured: At 2 years of age
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).
Measured: At 2 years of age
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).
Measured: At 2 years of age
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).
Measured: At 2 years of age
Evaluation of serum markers of bone metabolism
Assessed by Incidence of abnormal serum (Calcium, phosphorus, Alkaline phosphatase).
Measured: At visit 1 (<44 days)
Evaluation of serum markers of bone metabolism
Assessed by Incidence of abnormal serum (Calcium, phosphorus, Alkaline phosphatase).
Measured: At visit 4 (6 months)
Evaluation of urinary markers of bone metabolism
Assessed by Incidence of urine biochemistries (calcium, phosphorous).
Measured: At visit 1 (<44 days)
Evaluation of urinary markers of bone metabolism
Assessed by Incidence of urine biochemistries (calcium, phosphorous).
Measured: At visit 4 (6 months)
Body fat mass (%)
Assessed by Deterium dilution
Measured: evaluated until 5 years of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start31 Mar 2017 (estimated)
- Primary completion2 Jun 2017 (estimated)
- Study completion2 Jun 2017 (estimated)
Why it stopped: Sponsor decision stopped in June 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Small for Gestational AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360967
- Sponsor's protocol ID
- 14.11.INF
- Status last verified
- Apr 2020
- First submitted
- 10 Jan 2017
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopment, Growth, and Metabolic Syndrome Biomarkers in Term Small-for-gestational-age Infants Fed Standard or Nutrient-enriched Formula
- ClinicalTrials.gov ID
- NCT04360967
- Acronym / sponsor ID
- 14.11.INF
- Conditions
- Infant, Small for Gestational Age
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision stopped in June 2017
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2017 (estimated)
- Primary completion
- 2 Jun 2017 (estimated)
- Study completion
- 2 Jun 2017 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Randomized Standard Formula-fed | Experimental | Other: Standard FormulaProduct will be given to the formula-fed groups during the intervention phase of the study (enrollment to age 6 months). |
| Randomized Nutrient-enriched formula-fed | Experimental | Other: Nutrient-enriched FormulaProduct will be given to the formula-fed groups during the intervention phase of the study (enrollment to age 6 months). |
| 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. |
Who may qualify
- Ages
- 1 day to 44 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard FormulaStandard Formula | Other | Randomized Standard Formula-fed |
| Nutrient-enriched FormulaNutrient-enriched Formula | Other | Randomized Nutrient-enriched formula-fed |
Primary outcome
Evaluation of neurodevelopment
Time frame: at the baseline (2 years of age)
Assessed using Bayley Scales of Infant and Toddler Development® - Third Edition - (To compare with the standard Bayley scores).
Evaluation of length-for-age Z-score
Time frame: Evaluated once at 2 years of age
Using the WHO growth chart
Systolic Blood pressure
Time frame: at baseline (2 years of age)
Systolic and diastolic blood pressure measurement from 1 to 6 months of age
13 secondary outcomes
Evaluation of insulin sensitivity
Time frame: at Baseline ( 2 years of age).
Evaluation of insulin sensitivity
Time frame: at last visit ( 5 years of age).
Neurodevelopment
Time frame: At last visit ( 5 years of age)
Safety (Adverse Event reporting)
Time frame: From 1 to 6 months of age & 6 months to 5 years of age.
Growth (Length)
Time frame: At 2 years of age
Growth (Weight)
Time frame: At 2 years of age
Growth (Head circumference)
Time frame: At 2 years of age
Growth (Z-Scores)
Time frame: At 2 years of age
Evaluation of serum markers of bone metabolism
Time frame: At visit 1 (<44 days)
Evaluation of serum markers of bone metabolism
Time frame: At visit 4 (6 months)
Evaluation of urinary markers of bone metabolism
Time frame: At visit 1 (<44 days)
Evaluation of urinary markers of bone metabolism
Time frame: At visit 4 (6 months)
Body fat mass (%)
Time frame: evaluated until 5 years of age.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Formula and Nutrient-enriched Formula in people with Infant, Small for Gestational Age, run by Société des Produits Nestlé (SPN).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of neurodevelopment (time frame: at the baseline (2 years of age)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.