Neurocognitive Follow-Up (FU) Study

Nestlé

Status: Completed

Conditions: Cognitive Developmental Delay

Treatments: Other: Neurocognitive Follow-up

Study type: Observational

Funder types: Industry

Identifiers

NCT04962035

2006INF

Details and patient eligibility

About

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).

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 17 to 25 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

21 participants in 1 patient group

Alprem RTF Brain Follow-up

Description:

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

Treatment:

Other: Neurocognitive Follow-up