Expressive Language and Cognitive Early Development in Very Low Birth-Weight Preterm Toddlers

Completed

• Conditions: Prematurity

• Registration Number: NCT00689676
• Lead Sponsor: University of Sao Paulo

Brief Summary

The aim of the present study is to describe the performance of very low birth-weight preterm toddlers regarding expressive language and cognitive development during sensorimotor and beginning of pre-operational periods, as well as to compare the performance presented by these children to that presented by their full-term peers, according to Genetic Epistemology theoretical principles.

The hypothesis of this study is that very-low birth weight preterms would present a poorer performance, concerning expressive language and cognition development,than their full-term peers.

Detailed Description

Very low birth weight preterm infants are known to have risks of cognitive and behavioral problems, including learning difficulties, attention deficits and hyperactivity, as well as neuromotor deficits. Moreover, they are reported to have a high risk of speech and language impairments up to school age, even in cases where major neurological abnormalities are excluded. Impairments have been reported both in receptive and expressive language and, more specifically, in morphosyntax and naming.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-13
• Last Update Posted: 2009-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• gestational age lower than 34 weeks (according to the date of last menstrual period - DLMP);
• birth weight equal or lower than 1500g;
• exposed only to Brazilian Portuguese

Exclusion Criteria

• presence of major malformations, genetic syndromes, severe neonatal asphyxia, hearing impairment or visual impairment.

Control Group:

Inclusion Criteria:

• gestational age higher than 38 weeks;
• adequate for gestational age;
• birth weight higher than 2500g up to 3999g
• exposed only to Brazilian Portuguese

Exclusion Criteria:

• pre, peri or post natal intercurrence

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance on monthly observations carried out after the initial evaluation	18 months

Trial Locations

Locations (1)

University's Hospital; 🇧🇷 Sao Paulo, Brazil