Longitudinal Study of Intra-Uterine Growth Restriction

February 3, 2023 updated by: University of Colorado, Denver

Longitudinal Study of Intra-Uterine Growth Restriction (IUGR)

The investigation will employ a longitudinal approach in which every fetus diagnosed to be SGA (Small for Gestational Age ) will be studied at frequent intervals with sophisticated imaging techniques to assess subtle physiologic changes in the brain, heart, and placenta over time. These findings will be correlated with neurological and cardiovascular function in the newborn and early childhood. This research initiative should yield diagnostic and therapeutic templates that will improve the quality of life of IUGR babies in addition to providing important information that will better inform current diagnostic practices.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The overarching objective is to serially assess changes in the fetal circulation, heart, and brain with sophisticated ultrasound, MRI (Magnetic Resonance Imaging), and body composition techniques that will provide clues as to how growth restricted babies will tolerate life outside the uterus. Employing a longitudinal study will allow the investigators to correlate perinatal and postnatal outcomes more comprehensively than previous studies.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Denver Anschutz Medical Campus
        • Contact:
        • Sub-Investigator:
          • Sharon Hunter, PhD
        • Sub-Investigator:
          • Naila Naushad, MBBS
        • Sub-Investigator:
          • Jilliam Ellerman
        • Sub-Investigator:
          • Diane Gumina, PhD
        • Sub-Investigator:
          • Thomas Jansson, MD PhD
        • Sub-Investigator:
          • Theresa Powell, PhD
        • Sub-Investigator:
          • Lorna Moore, PhD
        • Sub-Investigator:
          • Emily Su, MD MSCI
        • Sub-Investigator:
          • Emma Peek, BS

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

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

University of Colorado School of Medicine is a referral center for women carrying fetuses with IUGR. Care providers routinely evaluate more than 300 patients per year at our outreach sites alone whose fetuses have estimated fetal weights below the 10th percentile. Of these, the investigators will initially enroll 200 patients per year between 24 and 36 weeks over a two-year period.

Description

Inclusion Criteria:

  • Patients with diagnosed SGA by an ultrasound estimated fetal weight (EFW) of less than the 10th percentile or a fetal abdominal circumference of less than the 5th percentile will be included in the study at the time of their first examination.

Exclusion Criteria:

  • Patients < 18 years of age, and chromosomal anomalies as identified by regular aneuploidy screening.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Small for Gestational Age Pregancies (controls)
Small for gestational age (SGA) pregnancies that do not develop IUGR will be considered controls. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
Radiation: Ultrasound
With 3-D and 4-D high-resolution color Doppler methods it is possible to map out the placental circulation, fetal circulation, fetal brain, and fetal cardiac function. Investigators will collect these data points prenatally.
Radiation: MRI
Similar to the Ultrasound data, investigators will collect MRI images of the fetal brain and the placenta. MRI will allow investigators to collect more detailed images of both the fetal brain and placenta, and investigators will be utilizing this technique both prenatally and postnatally.
Procedure: Blood collection
The maternal and cord blood will be collected for the processing of plasma and serum. There may be early biomarkers of IUGR in the maternal circulation that investigators can use to better determine the appropriate strategy for clinical management of care. Collection and subsequent analysis of molecular markers in the umbilical cord blood will be used to further confirm physiological dysfunction as detected by ultrasound and MRI techniques.
Procedure: Placental Analysis
Placentas will undergo pathological evaluation for placental function.
Procedure: Measurement of body fat
The baby's body fat will be measured in a special incubator called a PEAPOD or BODPOD when an infant.
Other Names:
  • Peapod
  • Bodpod
Behavioral: Neurological Function Assessment
Neurological development tests including a Bayley exam, Mullen exam, Developmental Profile-3, Child Behavior Checklist, and Pediatric Stroke Outcome Measure (PSOM) will be performed.
Radiation: Pediatric heart ultrasound
Children will have ultrasounds of their hearts during follow-up visits.
IUGR Pregnancies (cases)
Small for gestational age (SGA) pregnancies that do develop IUGR will be considered cases. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
Radiation: Ultrasound
With 3-D and 4-D high-resolution color Doppler methods it is possible to map out the placental circulation, fetal circulation, fetal brain, and fetal cardiac function. Investigators will collect these data points prenatally.
Radiation: MRI
Similar to the Ultrasound data, investigators will collect MRI images of the fetal brain and the placenta. MRI will allow investigators to collect more detailed images of both the fetal brain and placenta, and investigators will be utilizing this technique both prenatally and postnatally.
Procedure: Blood collection
The maternal and cord blood will be collected for the processing of plasma and serum. There may be early biomarkers of IUGR in the maternal circulation that investigators can use to better determine the appropriate strategy for clinical management of care. Collection and subsequent analysis of molecular markers in the umbilical cord blood will be used to further confirm physiological dysfunction as detected by ultrasound and MRI techniques.
Procedure: Placental Analysis
Placentas will undergo pathological evaluation for placental function.
Procedure: Measurement of body fat
The baby's body fat will be measured in a special incubator called a PEAPOD or BODPOD when an infant.
Other Names:
  • Peapod
  • Bodpod
Behavioral: Neurological Function Assessment
Neurological development tests including a Bayley exam, Mullen exam, Developmental Profile-3, Child Behavior Checklist, and Pediatric Stroke Outcome Measure (PSOM) will be performed.
Radiation: Pediatric heart ultrasound
Children will have ultrasounds of their hearts during follow-up visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize the sequence of neurological and cardiovascular events defining early and late IUGR pathogenesis, respectively
Time Frame: Every two weeks from the time of IUGR diagnosis or first visit
Using ultrasound and MRI to identify changes in the fetal vasculature, and fetal brain as early and late IUGR progress.
Every two weeks from the time of IUGR diagnosis or first visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate in utero adaptations in early and late IUGR, to infant and early childhood neurodevelopment
Time Frame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Assess neurodevelopment with a series of tests (PSOM, Bayleys III, Mullen's Scale of Early Learning, Developmental Profile-3, Child Behavior Checklist) and correlate neurological in utero findings to neurodevelopment outcomes after birth.
Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Correlate in utero adaptations in early and late IUGR, to infant and early childhood cardiovascular outcomes
Time Frame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Assess cardiovascular health via heart ultrasound after birth
Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Correlate in utero adaptations in early and late IUGR, to infant and early childhood metabolic outcomes
Time Frame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Correlate IUGR severity to metabolic outcomes as assessed by body composition (pea pod and bod pod with a pediatric attachment), anthropometrics, and a diet questionnaire after birth.
Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Compare early IUGR, late IUGR and SGA infant and early childhood outcomes
Time Frame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Using the tests describe above compare the outcomes of each group after birth.
Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Collaborators

The Perelman Family Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (ESTIMATE)

March 9, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1360

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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