Neurocognitive Follow-Up (FU) Study

NCT ID: NCT04962035

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-26

Study Completion Date

2021-12-22

Brief Summary

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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

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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

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Cognitive Developmental Delay

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Alprem RTF Brain Follow-up

Neurocognitive Follow-up of children previously having participated in the Alprem RTF study

Neurocognitive Follow-up

Intervention Type OTHER

Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.

Interventions

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Neurocognitive Follow-up

Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Infants / children born prematurely who were enrolled into the original clinical trial and who are less than 24 m of CA.
2. 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.
Minimum Eligible Age

17 Months

Maximum Eligible Age

25 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy

Krakow, , Poland

Site Status

Univerzitna nemocnica Martin

Martin, , Slovakia

Site Status

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, , Slovakia

Site Status

Countries

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Poland Slovakia

References

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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.

Reference Type DERIVED
PMID: 39649400 (View on PubMed)

Other Identifiers

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2006INF

Identifier Type: -

Identifier Source: org_study_id

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