Clinical Trial: Evaluation of Infants With Intrauterine Growth Restriction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Multidimensional Modeling in Evaluation of Infants With Intrauterine Growth Restriction

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.

Detailed Summary:
Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Current Primary Outcome:

  • Evaluation of serum IGF2 [ Time Frame: baseline ]
    serum IGF2
  • Evaluation of IGF2 receptors [ Time Frame: baseline ]
    serum IGF2 receptors


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Genetic evaluation [ Time Frame: baseline ]
    Number of subjects homozygous (A or G) and heterozygous (A/G) using forward primer: 5'- CTTGGACTTTGAGTCAAATTGG-3' and reverse primer: 5'-GGTCGTGCCAATTACATTTCA-3' genetic expression of IGF2 receptors. The groups will be evaluated in regards of polymorphism and allele frequencies.
  • Clinical assessment [ Time Frame: baseline ]
    Number of cases with respiratory distress, hyperbilirubinemia, early and late sepsis, hypoglicemia, necrozant enterocolitis or other co-morbidities.
  • Cardiac morphological and functional evaluation [ Time Frame: baseline and follow-up (1 month and/or 6 months) ]
    Eco cardiac measurements will be performed to all participants and the morphological and functional data will be recorded baseline for all participant (IUGR and controls). As results number of subjects with cardiac morphological and functional evaluation will be according with subjects included in the study and those subjects with cardiac modification or those from case group will be evaluated dynamically.


Original Secondary Outcome:

  • Genetic evaluation [ Time Frame: baseline ]
    genetic expression of IGF2 receptors
  • Clinical assessment [ Time Frame: baseline ]
    co-morbidities
  • Cardiac morphological and functional evaluation [ Time Frame: baseline and follow-up (1 month and/or 6 months) ]
    Eco cardiac measurements


Information By: Iuliu Hatieganu University of Medicine and Pharmacy

Dates:
Date Received: July 29, 2015
Date Started: June 2014
Date Completion: September 2016
Last Updated: August 4, 2015
Last Verified: August 2015