Evaluation of Infants With Intrauterine Growth Restriction

Multidimensional Modeling in Evaluation of Infants With Intrauterine Growth Restriction

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02515292

Acronym

ModeInfIUGR

Enrollment

Registered

2015-08-04

Start date

2014-06-30

Completion date

2016-09-30

Last updated

2015-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Growth Restriction

Keywords

IUGR (intrauterine growth restriction), IGF2 (insulin-like growth factor 2), morbidity

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 24 Hours

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of serum IGF2	baseline	serum IGF2
Evaluation of IGF2 receptors	baseline	serum IGF2 receptors

Secondary

Measure	Time frame	Description
Genetic evaluation	baseline	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.
Clinical assessment	baseline	Number of cases with respiratory distress, hyperbilirubinemia, early and late sepsis, hypoglicemia, necrozant enterocolitis or other co-morbidities.
Cardiac morphological and functional evaluation	baseline and follow-up (1 month and/or 6 months)	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.

Countries

Romania

Contacts

Primary ContactMonica Gabriela Hășmășanu, MD

popa.monica@umfcluj.ro+40741985974

Backup ContactSorana D. Bolboacă, PhD Habil

sbolboaca@umfcluj.ro+40750774506

Outcome results