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

NCT00689676 | Completed DMC

• 1 other identifier: 280674
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity

Keywords

expressive language; cognition; early development; very low birt weight; prematurity

Outcome Measures

Primary Outcomes (1)

• Performance on monthly observations carried out after the initial evaluation

  18 months

Study Arms (2)

Study Group

20 very low birth weight preterm toddlers

Control Group

20 full-term toddlers

Eligibility Criteria

• Age: 1 Month - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study Group: Very-Low Birth weight preterm newborns (mean weight: 1073g, mean gestational age: 29 3/7w), born in the Hospital of the University of São Paulo between March 2005 and February 2006, assisted in the High Risk Newborns Follow up Ambulatory of the University's Hospital. Control Group: Full-term newborns (mean weight: 3291g, mean gestational age: 39 1/7w), followed up in the Pediatrics Ambulatory of the University's Hospital and/or being assisted in the University' Hospital Nursery School.

You may qualify if:

• 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

You may not qualify if:

• presence of major malformations, genetic syndromes, severe neonatal asphyxia, hearing impairment or visual impairment.
• Control Group:
• gestational age higher than 38 weeks;
• adequate for gestational age;
• birth weight higher than 2500g up to 3999g
• exposed only to Brazilian Portuguese
• pre, peri or post natal intercurrence

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University's Hospital

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Suelly CO Limongi, PhD.

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: January 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 16, 2009

Record last verified: 2009-02

Locations

BR (1)