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

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689676
• Other study ID #: 280674
• Status: Completed
• Phase: N/A
• First received: May 29, 2008
• Last updated: February 13, 2009
• Start date: January 2006
• Est. completion date: October 2007

Study information

• Verified date: February 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 18 Months

Eligibility

Study Group:

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Birth Weight
• Premature Birth
• Prematurity

Locations

Country	Name	City	State
Brazil	University's Hospital	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on monthly observations carried out after the initial evaluation		18 months	No