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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	17 August 2015
Main ID:	NCT02515292
Date of registration:	29/07/2015
Prospective Registration:	No
Primary sponsor:	Iuliu Hatieganu University of Medicine and Pharmacy
Public title:	Evaluation of Infants With Intrauterine Growth Restriction ModeInfIUGR
Scientific title:	Multidimensional Modeling in Evaluation of Infants With Intrauterine Growth Restriction
Date of first enrolment:	June 2014
Target sample size:	60
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02515292
Study type:	Observational
Study design:	Observational Model: Case Control, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
Romania

Contacts

Name:	Monica Gabriela Ha?ma?anu, MD
Address:
Telephone:	+40741985974
Email:	popa.monica@umfcluj.ro
Affiliation:

Name:	Gabriela Zaharie, PhD, MD
Address:
Telephone:
Email:
Affiliation:	Iuliu Ha?ieganu Medicine and pharmacy University

Name:	Monica Hasmasanu, MD
Address:
Telephone:	+40741985974
Email:	popa.monica@umfcluj.ro
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum: N/A
Age maximum: 24 Hours
Gender: Both

Health Condition(s) or Problem(s) studied

Intrauterine Growth Restriction

Intervention(s)

Primary Outcome(s)

Evaluation of IGF2 receptors [Time Frame: baseline]

Evaluation of serum IGF2 [Time Frame: baseline]

Secondary Outcome(s)

Genetic evaluation [Time Frame: baseline]

Clinical assessment [Time Frame: baseline]

Cardiac morphological and functional evaluation [Time Frame: baseline and follow-up (1 month and/or 6 months)]

Secondary ID(s)

142 /181/ 20.05.2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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