Characterization of Neonatal Clinical Risk Profiles in Relation to Prenatal Obstetric Characteristics in Infants With Early-FGR Secondary to Doppler Flowmetry Alterations (NEO-FGR)

March 10, 2026 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
This study aims to characterize neonatal clinical risk profiles in relation to prenatal obstetric characteristics in infants with early fetal growth restriction (early-FGR) secondary to Doppler flowmetry alterations. The primary objective is to analyze the association between maternal and obstetric factors-such as preeclampsia, diabetes, and the timing and progression of Doppler changes-and neonatal clinical outcomes. The research evaluates how these relationships vary based on the prenatal flowmetric profile (umbilical artery [UA] with absent end-diastolic flow [UA bs-], UA with reversed end-diastolic flow [UA bs+], or UA alterations combined with ductus venosus [DV] changes) compared to preterm infants without FGR. Conducted as a spontaneous, multicenter, observational study with both retrospective and prospective components, the research involves mothers and their preterm neonates. The study population includes cases defined as neonates with a gestational age of 32 weeks or less and/or a birth weight under 1500 grams, with a prenatal history positive for FGR (fetal weight or abdominal circumference/fetal weight ratio below the 10th percentile) and documented fetal or utero-placental Doppler alterations. The control group consists of neonates within the same gestational age or weight criteria but without evidence of FGR or flowmetric alterations. Exclusion criteria apply to fetuses with known or suspected malformations or genetic anomalies, cases involving maternal substance abuse during pregnancy, and multiple pregnancies. With a total duration of 30 months, including 12 months for enrollment and 6 months for data analysis, the study targets a sample size of 850 subjects, comprising approximately 600 controls and 200 FGR cases. The statistical analysis will focus on pre-specified outcomes to assess the associations between maternal/obstetric factors and neonatal health, stratified by Doppler profile. Continuous variables will be summarized as mean and standard deviation or median and interquartile range, while categorical variables will be expressed as absolute frequencies and percentages. Group comparisons will utilize parametric or non-parametric tests based on data distribution. The main analysis will employ logistic regression models for binary outcomes and linear regression models for continuous outcomes, utilizing clustered standard errors by center to account for the multicenter design. Candidate covariates include gestational age, sex, and key maternal conditions such as preeclampsia, diabetes, pathological cardiotocography (CTG), and the timing of Doppler changes. To manage a high number of predictors relative to the sample size, penalization techniques such as lasso or elastic net will be applied for automatic covariate reduction and estimation stabilization. Subsequent analyses, including interaction models, will focus on the covariates selected through these procedures to provide a comprehensive understanding of how prenatal hemodynamic compromises influence the clinical trajectory of the preterm neonate.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study, titled "Characterization of clinical neonatal risk profiles in relation to prenatal obstetric characteristics in infants with Early Fetal Growth Restriction (FGR) secondary to Doppler flowmetry alterations," is designed as a multicenter, spontaneous, observational investigation combining both retrospective and prospective data collection to analyze the complex interplay between maternal-fetal hemodynamics and neonatal outcomes. The primary objective is to evaluate the association between specific maternal and obstetric factors-including preeclampsia, gestational diabetes, the timing of onset, and the longitudinal progression of Doppler alterations-and the resulting clinical neonatal outcomes. A key focus of the research is to determine how these relationships fluctuate according to the specific prenatal flowmetric profile, categorized by umbilical artery (UA) end-diastolic flow status (UA bs-, UA bs+, or UA combined with ductus venosus [DV] alterations), in comparison to a control group of preterm infants who did not experience FGR. The study population consists of mothers and their preterm neonates, specifically targeting those with a gestational age of 32 weeks or less and/or a birth weight under 1500 grams. The case group includes neonates with a documented prenatal history of FGR, defined by a fetal weight or abdominal circumference-to-fetal weight ratio below the 10th percentile, accompanied by abnormal fetal or utero-placental Doppler flowmetry. Conversely, the control group comprises neonates of similar gestational age or weight who showed no prenatal evidence of growth restriction or Doppler abnormalities. To maintain the integrity of the data regarding vascular-driven growth restriction, the study excludes pregnancies involving fetal malformations, known or suspected genetic anomalies, maternal substance abuse, and multiple gestations. Conducted over a total duration of 30 months, the timeline allocates 12 months for patient enrollment and selection and 6 months for comprehensive data analysis. The targeted sample size is 850 subjects, consisting of 600 neonates without an FGR diagnosis and 200 with a confirmed FGR diagnosis. The statistical methodology is rigorous and tailored to the multicenter nature of the study, synthesizing continuous variables as mean with standard deviation or median with interquartile range, while categorical variables will be presented as absolute frequencies and percentages. Exploratory comparisons between groups will utilize parametric or non-parametric tests based on data distribution. The primary analysis will employ logistic regression models for binary outcomes and linear regression models for continuous outcomes, utilizing clustered standard errors by center to account for intra-center correlation. Candidate covariates for these models include gestational age, sex, and significant maternal or obstetric conditions such as preeclampsia, diabetes, pathological cardiotocography (CTG), and the specific timing and progression of Doppler changes. In instances where the number of predictors is high relative to the statistical units, penalization techniques such as lasso or elastic net will be applied for automatic covariate reduction and estimate stabilization, ensuring that subsequent analyses and interaction studies focus on the most statistically relevant predictors. Informed consent is a mandatory prerequisite for participation, ensuring ethical standards are maintained throughout the retrospective and prospective phases of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bologna
      • Bologna, Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Mothers and their preterm neonates, including both subjects with FGR and Doppler alterations (UA bs-, UA bs+, UA+DV) and controls without evidence of FGR or flow velocity alterations.

Description

Inclusion Criteria:

  • Cases: neonates with a gestational age ≤32 weeks and/or birth weight < 1500 g, with a prenatal history positive for FGR (fetal weight < 10th percentile and/or abdominal circumference/fetal weight ratio < 10th percentile) and abnormal fetal and/or utero-placental Doppler findings
  • Controls: neonates with a gestational age ≤32 weeks and/or birth weight < 1500 g, without prenatal evidence of FGR or Doppler flow abnormalities
  • Obtaining informed consent.

Exclusion Criteria:

  • Fetal malformations and/or suspected or known genetic anomalies
  • Maternal substance abuse during pregnancy
  • Twin pregnancies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analyze the association between maternal and obstetric factors and neonatal clinical outcomes, evaluating differences and interactions among various prenatal Doppler profiles (UA bs-, UA bs+, UA+DV) and preterm controls without FGR.
Time Frame: 24 months after birth
postnatal growth (anthropometric z-scores)
24 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEO-FGR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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