Neurocognitive Follow-Up (FU) Study

Cognitive Developmental Delay Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04962035
• Other study ID #: 2006INF
• Status: Completed
• Start date: March 26, 2021
• Est. completion date: December 22, 2021

Study information

• Verified date: March 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 22, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Months to 25 Months

Eligibility

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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cognitive Developmental Delay

Intervention

Other:
• Neurocognitive Follow-up
Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.

Locations

Country	Name	City	State
Poland	Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy	Krakow
Slovakia	Univerzitna nemocnica Martin	Martin
Slovakia	Fakultna nemocnica s poliklinikou Nove Zamky	Nove Zamky

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Countries where clinical trial is conducted

Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months of CA
Secondary	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.	18 months of CA
Secondary	Weight	Child weight (g)	At enrollment, 18 and 24 months of CA
Secondary	Length/height	Child length/height (cm)	At enrollment, 18 and 24 months of CA
Secondary	Head circumference	Child head circumference (cm)	At enrollment, 18 and 24 months of CA
Secondary	Child temperament scores	Parent-reported child temperament questionnaire validated specifically for children between the ages of 18 and 36 months	At 18 and 24 months of CA
Secondary	Developmental Milestone scores	Parent-reported achievements of specific age-appropriate milestones (yes/no responses to child performing specific milestones or not)	At 18 and 24 months of CA
Secondary	Number of healthcare usage	Retrospective parent-reported recall of the number of healthcare usage and hospitalizations	At 18 and 24 months of CA
Secondary	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	At 18 and 24 months of CA