Evaluation of Infants With Intrauterine Growth Restriction

NCT02515292 | Unknown

• 1 other identifier: 142 /181/ 20.05.2014
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 2.Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and paraclinical. (Retrospective \& prospective)
3. 3.Evaluation and monitoring of morphological and functional by echocardiography. (Prospective)
4. 4.Integrating multidimensional clinical and paraclinical parameters in a statistical model for evaluating newborn with intrauterine growth restriction.

Conditions

Intrauterine Growth Restriction

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Evaluation of serum IGF2

  serum IGF2

  baseline

• Evaluation of IGF2 receptors

  serum IGF2 receptors

  baseline

Secondary Outcomes (3)

• Genetic evaluation

  baseline

• Clinical assessment

  baseline

• Cardiac morphological and functional evaluation

  baseline and follow-up (1 month and/or 6 months)

Study Arms (2)

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

control: newborn without intrauterine growth restriction

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

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Population with IUGR from a 3rd level maternity from Nord-West of Romania

You may qualify if:

• newborns with intrauterine growth restriction (IUGR): weight below the 10th percentile for gestational age
• parental consent for enrollment

You may not qualify if:

• IUGR neonates in the context chromosomopathies: trisomy 21, trisomy 18.
• neonates with congenital heart disease
• twins
• refusal of parents for participation to the study

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Neonatal-Ward, 1st Gynecology Clinic

Cluj-Napoca, Cluj, 400006, Romania

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriela Zaharie, PhD, MD

  Iuliu Hațieganu Medicine and pharmacy University

  STUDY CHAIR

Central Study Contacts

Monica Gabriela Hășmășanu, MD

CONTACT

+40741985974; popa.monica@umfcluj.ro

Sorana D. Bolboacă, PhD Habil

CONTACT

+40750774506; sbolboaca@umfcluj.ro

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 4, 2015
• Study Start: June 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

RO (1)