Evaluation of Infants With Intrauterine Growth Restriction

Study Overview
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Brief Summary
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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: 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) Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and paraclinical. (Retrospective & prospective) Evaluation and monitoring of morphological and functional by echocardiography. (Prospective) Integrating multidimensional clinical and paraclinical parameters in a statistical model for evaluating newborn with intrauterine growth restriction.

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

Conditions
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Intrauterine Growth Restriction

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IUGR: newborn with intrauterine growth restriction<br>Inclusion criteria: newborn infants with symmetrical (both weight and height lower than 10th percentile) or asymmetrical (birth weight is lower than 10th percentile but height and age-appropriated height) intrauterine growth restriction agreement of the parents that their child to be included in the study | |
| control: newborn without intrauterine growth restriction<br>Inclusion criteria: - matches newborn without intrauterine growth restriction in terms of gender and gestational age as IUGR group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of serum IGF2 | serum IGF2 | baseline | 
| Evaluation of IGF2 receptors | serum IGF2 receptors | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline | 
| Clinical assessment | Number of cases with respiratory distress, hyperbilirubinemia, early and late sepsis, hypoglicemia, necrozant enterocolitis or other co-morbidities. | 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. | baseline and follow-up (1 month and/or 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IUGR (intrauterine growth restriction), IGF2 (insulin-like growth factor 2), morbidity