Cognitive Developmental DelayNCT04962035
Neurocognitive Follow-Up (FU) Study
An observational study of Cognitive Developmental Delay, run by Société des Produits Nestlé (SPN) at 3 sites in 2 countries.
Trial summary
This is a follow-up study of a recently completed trial (17.14.INF) evaluating the growth of pre-term infants. Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA). Read more about this study
- Who is it for?
- Ages 17 to 25 monthsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Developmental Delay
- What is being tested?
- Neurocognitive Follow-up
- How many people
- 21 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 26 Mar 2021to 22 Dec 2021
- Phase
- Observational
- 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 17 to 25 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants who have previously participated in the 17.14.INF Alprem RTF study are eligible to participate, wherein preterm infants of gestational age ≥ 27 weeks and ≤ 32 weeks with body weight <1500g and appropriate for gestational age (AGA) as defined by weight ≥10 percentile and ≤90 percentile on the Fenton growth chart had been enrolled.
Who may be able to join
- Infants / children born prematurely who were enrolled into the original clinical trial and who are less than 24 m of CA.
- Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.
Who cannot join
- 1. Infants identified retrospectively as not meeting the inclusion or exclusion criteria for the original study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Slovakia2 sites
Univerzitna nemocnica Martin
Martin, 3659
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, 940 34
Poland1 site
Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy
Krakow, 30-663
About this study
Official title: Neurocognitive Scores of Predominantly Formula Fed Preterm Infants in Early Childhood Years
This is a follow-up study of a recently completed trial (17.14.INF) evaluating the growth of pre-term infants. Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA).
Read the detailed description
This is a follow-up study of a recently completed multi-center, prospective, single-arm, open-label interventional trial (17.14.INF - Alprem RTF: NCT03728764) evaluating the growth of pre-term infants receiving a two-stage PTF feeding system while in the neonatal care unit and continuing until 30 days post-discharge.
Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA). The timing of the cognitive assessments aligns with routine check-up visits and reflect the period at which developmental delays may first become evident.
- Conditions
- Cognitive Developmental Delay
- Being tested
- Neurocognitive Follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive Follow-upOther
Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.
| Study group | Role | What they receive |
|---|---|---|
| Alprem RTF Brain Follow-up | Neurocognitive Follow-up of children previously having participated in the Alprem RTF study Receives: Other: Neurocognitive Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley-III scores at 24 months
Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) cognitive score at 24 months of corrected age (CA). Composite scores range 40-160, with a mean of 100 and SD of 10 points. A composite score of 70 or less is an indication of a delay in child neurocognitive development.
Measured: 24 months of CA
Secondary outcomes (8)
Bayley-III scores at 18 months
Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) cognitive score at 18 months of corrected age (CA). Composite scores range 40-160, with a mean of 100 and SD of 10 points. A composite score of 70 or less is an indication of a delay in child neurocognitive development.
Measured: 18 months of CA
Weight
Child weight (g)
Measured: At enrollment, 18 and 24 months of CA
Length/height
Child length/height (cm)
Measured: At enrollment, 18 and 24 months of CA
Head circumference
Child head circumference (cm)
Measured: At enrollment, 18 and 24 months of CA
Child temperament scores
Parent-reported child temperament questionnaire validated specifically for children between the ages of 18 and 36 months
Measured: At 18 and 24 months of CA
Developmental Milestone scores
Parent-reported achievements of specific age-appropriate milestones (yes/no responses to child performing specific milestones or not)
Measured: At 18 and 24 months of CA
Number of healthcare usage
Retrospective parent-reported recall of the number of healthcare usage and hospitalizations
Measured: At 18 and 24 months of CA
Feeding patterns
Feeding practice outcomes collected retrospectively at each visit via a parent-reported questionnaire related to breastfeeding duration, prevalence of formula feeding, and age at initiation of complementary feeding
Measured: At 18 and 24 months of CA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start26 Mar 2021
- Primary completion30 Nov 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive Developmental DelayStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 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
- NCT04962035
- Sponsor's protocol ID
- 2006INF
- Status last verified
- Mar 2023
- First submitted
- 29 Apr 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwinta P, Lazarova S, Demova K, Chen Y, Hartweg M, Krattinger LF, Fumero C, Buczynska A, Durlak W, Uhrikova Z, Kozar M, Samuel TM, Zibolen M. Effects of two-stage preterm formulas on growth, nutritional biomarkers, and neurodevelopment in preterm infants. Front Pediatr. 2024 Nov 22;12:1427050. doi: 10.3389/fped.2024.1427050. eCollection 2024.
PubMed 39649400
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Scores of Predominantly Formula Fed Preterm Infants in Early Childhood Years
- ClinicalTrials.gov ID
- NCT04962035
- Acronym / sponsor ID
- 2006INF
- Conditions
- Cognitive Developmental Delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 14 Jul 2021 (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.
This is a follow-up study of a recently completed trial (17.14.INF) evaluating the growth of pre-term infants. Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA).
Detailed description
This is a follow-up study of a recently completed multi-center, prospective, single-arm, open-label interventional trial (17.14.INF - Alprem RTF: NCT03728764) evaluating the growth of pre-term infants receiving a two-stage PTF feeding system while in the neonatal care unit and continuing until 30 days post-discharge.
Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA). The timing of the cognitive assessments aligns with routine check-up visits and reflect the period at which developmental delays may first become evident.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alprem RTF Brain Follow-up | – | Other: Neurocognitive Follow-upNeurocognitive Follow-up of children previously having participated in the Alprem RTF study |
Who may qualify
- Ages
- 17 to 25 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants who have previously participated in the 17.14.INF Alprem RTF study are eligible to participate, wherein preterm infants of gestational age ≥ 27 weeks and ≤ 32 weeks with body weight <1500g and appropriate for gestational age (AGA) as defined by weight ≥10 percentile and ≤90 percentile on the Fenton growth chart had been enrolled.
Key inclusion criteria (2 listed)
- Infants / children born prematurely who were enrolled into the original clinical trial and who are less than 24 m of CA.
- Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.
Key exclusion criteria (1 listed)
- 1. Infants identified retrospectively as not meeting the inclusion or exclusion criteria for the original study.
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 |
|---|---|---|
| Neurocognitive Follow-upStandard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions. | Other | Alprem RTF Brain Follow-up |
Primary outcome
Bayley-III scores at 24 months
Time frame: 24 months of CA
Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) cognitive score at 24 months of corrected age (CA). Composite scores range 40-160, with a mean of 100 and SD of 10 points. A composite score of 70 or less is an indication of a delay in child neurocognitive development.
8 secondary outcomes
Bayley-III scores at 18 months
Time frame: 18 months of CA
Weight
Time frame: At enrollment, 18 and 24 months of CA
Length/height
Time frame: At enrollment, 18 and 24 months of CA
Head circumference
Time frame: At enrollment, 18 and 24 months of CA
Child temperament scores
Time frame: At 18 and 24 months of CA
Developmental Milestone scores
Time frame: At 18 and 24 months of CA
Number of healthcare usage
Time frame: At 18 and 24 months of CA
Feeding patterns
Time frame: At 18 and 24 months of CA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 39649400Kwinta P, Lazarova S, Demova K, Chen Y, Hartweg M, Krattinger LF, Fumero C, Buczynska A, Durlak W, Uhrikova Z, Kozar M, Samuel TM, Zibolen M. Effects of two-stage preterm formulas on growth, nutritional biomarkers, and neurodevelopment in preterm infants. Front Pediatr. 2024 Nov 22;12:1427050. doi: 10.3389/fped.2024.1427050. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Cognitive Developmental Delay
RecruitingObservational study
Characterization of Dysmorphology in Subjects With Creatine Transporter Deficiency
Cognitive Disorder, Metabolic Disease
Recruiting
Interventions in Mathematics and Cognitive Skills
Math Learning Disability, Child Development
Active, not recruiting
Mental And Speech Developmental Delay Autism Spectrum-Type Behavioral Disorder
Autism Spectrum Disorder (ASD), Central Auditory Processing Disorder
RecruitingObservational study
Assessing Intellectual and Motor Outcomes in High-risk Infants
Cerebral Palsy, Cerebral Palsy (CP)
RecruitingObservational study
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Developmental Delay, run by Société des Produits Nestlé (SPN) at 3 sites in 2 countries.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovakia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bayley-III scores at 24 months (time frame: 24 months of CA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04962035, which also lists 1 linked publication.
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 Mar 2023.