Intrauterine Growth RestrictionModeInfIUGRNCT02515292
Evaluation of Infants With Intrauterine Growth Restriction
An observational study of Intrauterine Growth Restriction, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Intrauterine Growth Restriction
- How many people
- 60 participants
- Where
- 1 siteRomania
- Study dates
- Jun 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Study population: Population with IUGR from a 3rd level maternity from Nord-West of Romania
Who may be able to join
- newborns with intrauterine growth restriction (IUGR): weight below the 10th percentile for gestational age
- parental consent for enrollment
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Neonatal-Ward, 1st Gynecology Clinic
Cluj-Napoca, Cluj, 400006
Monica Hăşmăşanu, MD, +40741985974, popa.monica@umfcluj.ro
Sorana D. Bolboacă, PhD Habil, MD, +40750774506, sbolboaca@umfcluj.ro
About this study
Official title: Multidimensional Modeling in Evaluation of Infants With Intrauterine Growth Restriction
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:
- 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)
- Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and paraclinical. (Retrospective \& prospective)
- Evaluation and monitoring of morphological and functional by echocardiography. (Prospective)
- 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
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of serum IGF2
serum IGF2
Measured: baseline
Evaluation of IGF2 receptors
serum IGF2 receptors
Measured: baseline
Secondary outcomes (3)
Genetic evaluation
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.
Measured: baseline
Clinical assessment
Number of cases with respiratory distress, hyperbilirubinemia, early and late sepsis, hypoglicemia, necrozant enterocolitis or other co-morbidities.
Measured: baseline
Cardiac morphological and functional evaluation
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.
Measured: baseline and follow-up (1 month and/or 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJun 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hășmășanu Monica Gabriela, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Gabriela Zaharie, PhD, MD, Study chair, Iuliu Hațieganu Medicine and pharmacy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515292
- Sponsor's protocol ID
- 142 /181/ 20.05.2014
- Acronym
- ModeInfIUGR
- Status last verified
- Aug 2015
- First submitted
- 29 Jul 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Modeling in Evaluation of Infants With Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT02515292
- Acronym / sponsor ID
- ModeInfIUGR / 142 /181/ 20.05.2014
- Conditions
- Intrauterine Growth Restriction
- Keywords
- IUGR (intrauterine growth restriction), IGF2 (insulin-like growth factor 2), morbidity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
- Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and paraclinical. (Retrospective \& prospective)
- Evaluation and monitoring of morphological and functional by echocardiography. (Prospective)
- Integrating multidimensional clinical and paraclinical parameters in a statistical model for evaluating newborn with intrauterine growth restriction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Population with IUGR from a 3rd level maternity from Nord-West of Romania
Key inclusion criteria (2 listed)
- newborns with intrauterine growth restriction (IUGR): weight below the 10th percentile for gestational age
- parental consent for enrollment
Key exclusion criteria (4 listed)
- IUGR neonates in the context chromosomopathies: trisomy 21, trisomy 18.
- neonates with congenital heart disease
- twins
- refusal of parents for participation to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of serum IGF2
Time frame: baseline
serum IGF2
Evaluation of IGF2 receptors
Time frame: baseline
serum IGF2 receptors
3 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
Related trials for Intrauterine Growth Restriction
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
RecruitingObservational study
Primordial Dwarfism Registry
MOPDII, Meier-Gorlin Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Zaharie, PhD, MD study chair
Iuliu Hațieganu Medicine and pharmacy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Gabriela Hășmășanu, MD (+40741985974, popa.monica@umfcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of serum IGF2 (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.