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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02515292
Other study ID # 142 /181/ 20.05.2014
Secondary ID
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


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
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