Evaluation of Infants With Intrauterine Growth Restriction (ModeInfIUGR)

Iuliu Hatieganu University of Medicine and Pharmacy

Status: Unknown

Conditions: Intrauterine Growth Restriction

Study type: Observational

Funder types: Other

Identifiers

NCT02515292

142 /181/ 20.05.2014

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

IUGR: newborn with intrauterine growth restriction

Description:

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

Description:

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