Evaluation of Infants With Intrauterine Growth Restriction

NCT ID: NCT02515292

Last Updated: 2015-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-09-30

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:

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

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Conditions

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Intrauterine Growth Restriction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

control: newborn without intrauterine growth restriction

Inclusion criteria:

\- matches newborn without intrauterine growth restriction in terms of gender and gestational age as IUGR group

No interventions assigned to this group

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
Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Hășmășanu Monica Gabriela

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabriela Zaharie, PhD, MD

Role: STUDY_CHAIR

Iuliu Hațieganu Medicine and pharmacy University

Locations

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Neonatal-Ward, 1st Gynecology Clinic

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Monica Gabriela Hășmășanu, MD

Role: CONTACT

+40741985974

Sorana D. Bolboacă, PhD Habil

Role: CONTACT

+40750774506

Facility Contacts

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Monica Hăşmăşanu, MD

Role: primary

+40741985974

Sorana D. Bolboacă, PhD Habil, MD

Role: backup

+40750774506

Other Identifiers

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142 /181/ 20.05.2014

Identifier Type: -

Identifier Source: org_study_id

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