Clinical trial NCT04962035: Neurocognitive Follow-Up (FU) Study
Official title: Neurocognitive Scores of Predominantly Formula Fed Preterm Infants in Early Childhood Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Developmental Delay
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 21
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bayley-III scores at 24 months
timeFrame: 24 months of CA
Secondary outcomes:
measure: Bayley-III scores at 18 months
timeFrame: 18 months of CA
measure: Weight
timeFrame: At enrollment, 18 and 24 months of CA
measure: Length/height
timeFrame: At enrollment, 18 and 24 months of CA
measure: Head circumference
timeFrame: At enrollment, 18 and 24 months of CA
measure: Child temperament scores
timeFrame: At 18 and 24 months of CA
measure: Developmental Milestone scores
timeFrame: At 18 and 24 months of CA
measure: Number of healthcare usage
timeFrame: At 18 and 24 months of CA
measure: Feeding patterns
timeFrame: At 18 and 24 months of CA
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Nove Zamky
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Nove Zamky
Study officials:
References: