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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00689676
First received: May 29, 2008
Last updated: February 13, 2009
Last verified: February 2009
  Purpose

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.


Condition
Prematurity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Expressive Language and Cognitive Early Development in Very Low Birth-Weight Preterm Toddlers

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Performance on monthly observations carried out after the initial evaluation [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Group
20 very low birth weight preterm toddlers
Control Group
20 full-term toddlers

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.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689676

Locations
Brazil
University's Hospital
Sao Paulo, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Suelly CO Limongi, PhD. University of Sao Paulo
  More Information

No publications provided

Responsible Party: Suelly Cecilia Olivan Limongi, University of São Paulo
ClinicalTrials.gov Identifier: NCT00689676     History of Changes
Other Study ID Numbers: 280674
Study First Received: May 29, 2008
Last Updated: February 13, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
expressive language
cognition
early development
very low birt weight
prematurity

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014