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NCT Number: NCT02382601

Longitudinal Study of Intra-Uterine Growth Restriction

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.

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Key information

Conditions

IUGR Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Bettina Cuneo, MD

SUB_INVESTIGATOR

Colleen Julian, PhD

SUB_INVESTIGATOR

David Mirsky, MD

SUB_INVESTIGATOR

Diane Gumina, PhD

SUB_INVESTIGATOR

Emily Su, MD MSCI

SUB_INVESTIGATOR

Emma Peek, BS

CONTACT

[email protected]

Emma Peek, BS

SUB_INVESTIGATOR

Henry Galan, MD

SUB_INVESTIGATOR

Jennifer Armstrong-Wells, MD

SUB_INVESTIGATOR

Jilliam Ellerman

SUB_INVESTIGATOR

John Hobbins, MD

PRINCIPAL_INVESTIGATOR

Laura Brown, MD

SUB_INVESTIGATOR

Lisa Howley, MD

SUB_INVESTIGATOR

Lorna Moore, PhD

SUB_INVESTIGATOR

Mariana Meyers, MD

SUB_INVESTIGATOR

Mike Zaretsky, MD

SUB_INVESTIGATOR

Miriam Post, MD

SUB_INVESTIGATOR

Naila Naushad, MBBS

SUB_INVESTIGATOR

Sean Deoni, MD

SUB_INVESTIGATOR

Shane Reeves, MD

SUB_INVESTIGATOR

Sharon Hunter, PhD

SUB_INVESTIGATOR

Theresa Powell, PhD

SUB_INVESTIGATOR

Thomas Jansson, MD PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Radiation

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.

MRI

Radiation

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.

Blood Collection

Procedure

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.

Neurological Function Assessment

Behavioral

Neurological development tests including a Bayley exam, Mullen exam, Developmental Profile-3, Child Behavior Checklist, and Pediatric Stroke Outcome Measure (PSOM) will be performed.

Placental Analysis

Procedure

Placentas will undergo pathological evaluation for placental function.

Measurement of body fat

Procedure

The baby's body fat will be measured in a special incubator called a PEAPOD or BODPOD when an infant.

Other names: Peapod, Bodpod

Pediatric heart ultrasound

Radiation

Children will have ultrasounds of their hearts during follow-up visits.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Peek, BS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • The Perelman Family Foundation

Registry information

Official study title

Longitudinal Study of Intra-Uterine Growth Restriction (IUGR)

Important dates

Study start
2015
Primary completion
2028
Study completion
2028
First posted
Mar 9, 2015
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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