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Completed

NCT Number: NCT04962035

Neurocognitive Follow-Up (FU) Study

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).

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Key information

Conditions

Cognitive Developmental Delay

Age range

17 month–25 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy, Krakow, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Infants identified retrospectively as not meeting the inclusion or exclusion criteria for the original study.

Treatment and study plan

Neurocognitive Follow-up

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Bayley-III scores at 18 months

    Time frame: 18 months of CA

    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.

  2. Weight

    Time frame: At enrollment, 18 and 24 months of CA

    Child weight (g)

  3. Length/height

    Time frame: At enrollment, 18 and 24 months of CA

    Child length/height (cm)

  4. Head circumference

    Time frame: At enrollment, 18 and 24 months of CA

    Child head circumference (cm)

  5. Child temperament scores

    Time frame: At 18 and 24 months of CA

    Parent-reported child temperament questionnaire validated specifically for children between the ages of 18 and 36 months

  6. Developmental Milestone scores

    Time frame: At 18 and 24 months of CA

    Parent-reported achievements of specific age-appropriate milestones (yes/no responses to child performing specific milestones or not)

  7. Number of healthcare usage

    Time frame: At 18 and 24 months of CA

    Retrospective parent-reported recall of the number of healthcare usage and hospitalizations

  8. Feeding patterns

    Time frame: At 18 and 24 months of CA

    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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Neurocognitive Scores of Predominantly Formula Fed Preterm Infants in Early Childhood Years

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2021
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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