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Clinical Trials/NCT02515292
NCT02515292UnknownNot Applicable

Multidimensional Modeling in Evaluation of Infants With Intrauterine Growth Restriction

Iuliu Hatieganu University of Medicine and Pharmacy1 site in 1 country60 target enrollmentStarted: June 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Evaluation of serum IGF2
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Purpose: Clinical assessment (anthropometric) and paraclinical (biochemical and immunological by dosing serum insuline growth factors IGF1 and IGF2 and their receptors) of neonates with intrauterine growth restriction (IUGR) and the integration in a multidimensional statistical model .

Objectives:

  1. IGF1 and IGF2 evaluation of serum and IGF1 receptor, IGF2 receptor and IGF2 receptor gene expression in cord blood from newborns with intrauterine growth restriction (IUGR). (Prospective)
  2. Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and paraclinical. (Retrospective & prospective)
  3. Evaluation and monitoring of morphological and functional by echocardiography. (Prospective)
  4. Integrating multidimensional clinical and paraclinical parameters in a statistical model for evaluating newborn with intrauterine growth restriction.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 24 Hours (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •newborns with intrauterine growth restriction (IUGR): weight below the 10th percentile for gestational age
  • •parental consent for enrollment

Exclusion Criteria

  • •IUGR neonates in the context chromosomopathies: trisomy 21, trisomy
  • •neonates with congenital heart disease
  • •refusal of parents for participation to the study

Outcomes

Primary Outcomes

Evaluation of serum IGF2

Time Frame: baseline

serum IGF2

Evaluation of IGF2 receptors

Time Frame: baseline

serum IGF2 receptors

Secondary Outcomes

  • Clinical assessment(baseline)
  • Genetic evaluation(baseline)
  • Cardiac morphological and functional evaluation(baseline and follow-up (1 month and/or 6 months))

Investigators

Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hășmășanu Monica Gabriela

MD

Iuliu Hatieganu University of Medicine and Pharmacy

Study Sites (1)

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