Evaluation of Infants With Intrauterine Growth Restriction (ModeInfIUGR)

Multidimensional Modeling in Evaluation of Infants With Intrauterine Growth Restriction

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 Overview

• Status: Unknown
• Conditions: Intrauterine Growth Restriction

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Monica Gabriela Hășmășanu, MD; Phone Number: +40741985974; Email: popa.monica@umfcluj.ro
• Study Contact Backup: Name: Sorana D. Bolboacă, PhD Habil; Phone Number: +40750774506; Email: sbolboaca@umfcluj.ro

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • Recruiting
      • Neonatal-Ward, 1st Gynecology Clinic
      • Contact: Monica Hăşmăşanu, MD; Phone Number: +40741985974; Email: popa.monica@umfcluj.ro
      • Contact: Sorana D. Bolboacă, PhD Habil, MD; Phone Number: +40750774506; Email: sbolboaca@umfcluj.ro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population with IUGR from a 3rd level maternity from Nord-West of Romania

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
IUGR: newborn with intrauterine growth restriction; 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; Inclusion criteria: - matches newborn without intrauterine growth restriction in terms of gender and gestational age as IUGR group

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
• Investigators: Study Chair: Gabriela Zaharie, PhD, MD, Iuliu Hațieganu Medicine and pharmacy University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: July 31, 2015
• First Posted (Estimate): August 4, 2015

Study Record Updates

• Last Update Posted (Estimate): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: morbidity; IUGR (intrauterine growth restriction); IGF2 (insulin-like growth factor 2)
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation
• Other Study ID Numbers: 142 /181/ 20.05.2014