Evaluation of Infants With Intrauterine Growth Restriction

Intrauterine Growth Restriction Clinical Trial

— ModeInfIUGR  

Official title:

Multidimensional Modeling in Evaluation of Infants With Intrauterine Growth Restriction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02515292
• Other study ID #: 142 /181/ 20.05.2014
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2015
• Last updated: August 4, 2015
• Start date: June 2014
• Est. completion date: September 2016

Study information

• Verified date: August 2015
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: Monica Gabriela Ha?ma?anu, MD
• Phone: +40741985974
• Email: popa.monica[@]umfcluj.ro
• Is FDA regulated: No
• Health authority: Romania: Iuliu Hatieganu University of Medicine and Pharmacy
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction

Locations

Country	Name	City	State
Romania	Neonatal-Ward, 1st Gynecology Clinic	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of serum IGF2	serum IGF2	baseline	Yes
Primary	Evaluation of IGF2 receptors	serum IGF2 receptors	baseline	Yes
Secondary	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	Yes
Secondary	Clinical assessment	Number of cases with respiratory distress, hyperbilirubinemia, early and late sepsis, hypoglicemia, necrozant enterocolitis or other co-morbidities.	baseline	Yes
Secondary	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)	Yes