Evaluation of Infants With Intrauterine Growth Restriction

• Conditions: Intrauterine Growth Restriction

• Registration Number: NCT02515292
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

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 Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-07-31
• Status Verified: 2015-08
• Study First Posted: 2015-08-04
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-06
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of serum IGF2	baseline	serum IGF2
Evaluation of IGF2 receptors	baseline	serum IGF2 receptors

Secondary Outcome Measures

Name	Time	Method
Clinical assessment	baseline	Number of cases with respiratory distress, hyperbilirubinemia, early and late sepsis, hypoglicemia, necrozant enterocolitis or other co-morbidities.
Genetic evaluation	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.
Cardiac morphological and functional evaluation	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.

Trial Locations

Locations (1)

Neonatal-Ward, 1st Gynecology Clinic; 🇷🇴 Cluj-Napoca, Cluj, Romania