Evaluation of Infants With Intrauterine Growth Restriction

Iuliu Hatieganu University of Medicine and Pharmacy60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Intrauterine Growth Restriction

Eligibility

Sex: ALLMax age: 24 Hours

Medical Language ↔ Plain English

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 18. * neonates with congenital heart disease * twins * refusal of parents for participation to the study

Locations (1)

Outcomes

Primary Outcomes

Evaluation of serum IGF2

serum IGF2

Time frame: baseline

Evaluation of IGF2 receptors

serum IGF2 receptors

Time frame: baseline

Secondary Outcomes

Genetic evaluation

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.

Time frame: baseline

Clinical assessment

Number of cases with respiratory distress, hyperbilirubinemia, early and late sepsis, hypoglicemia, necrozant enterocolitis or other co-morbidities.

Time frame: baseline

Cardiac morphological and functional evaluation

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.

Time frame: baseline and follow-up (1 month and/or 6 months)

Evaluation of Infants With Intrauterine Growth Restriction

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts