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Longitudinal Study of Intra-Uterine Growth Restriction

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ClinicalTrials.gov Identifier: NCT02382601
Recruitment Status : Recruiting
First Posted : March 9, 2015
Last Update Posted : August 31, 2017
Sponsor:
Collaborator:
The Perelman Family Foundation
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment
IUGR Pregnancy Radiation: Ultrasound Radiation: MRI Procedure: Blood collection Behavioral: Neurological Function Assessment Procedure: Placental Analysis Procedure: Measurement of body fat

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
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Longitudinal Study of Intra-Uterine Growth Restriction (IUGR)
Actual Study Start Date : April 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

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.

Behavioral: Neurological Function Assessment
Neurological development tests called a Bayley exam and Pediatric Stroke Outcome Measure (PSOM) will be performed.

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

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.

Behavioral: Neurological Function Assessment
Neurological development tests called a Bayley exam and Pediatric Stroke Outcome Measure (PSOM) will be performed.

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Correlate in utero adaptations in early and late IUGR, to infant and early childhood neurodevelopment [ Time Frame: Baseline (Day 0), 6 months, 1 year, and 2 years ]
    Assess neurodevelopment with a series of tests (PSOM, Bayleys III, Mullen's Scale of Early Learning) and correlate neurological in utero findings to neurodevelopment outcomes at 40-44 weeks gestational age (baseline).

  2. Correlate in utero adaptations in early and late IUGR, to infant and early childhood cardiovascular outcomes [ Time Frame: Baseline (Day 0), 6 months, 1 year, and 2 years ]
    Assess cardiovascular health via echocardiograms at 40-44 weeks gestational age (baseline).

  3. Correlate in utero adaptations in early and late IUGR, to infant and early childhood metabolic outcomes [ Time Frame: Baseline (Day 0), 6 months, 1 year, and 2 years ]
    Correlate IUGR severity to metabolic outcomes as assessed by body composition (pea pod and bod pod with a pediatric attachment), and questionnaires on infant feeding: Infant Feeding Practices II, and Infant Feeding Questionnaire at 40-44 weeks gestational age (baseline).

  4. Compare early IUGR, late IUGR and SGA infant and early childhood outcomes [ Time Frame: Baseline (Day 0), 6 months, 1 year, and 2 years ]
    Using the tests describe above compare the outcomes of each group at 40-44 weeks gestational age (baseline).


Biospecimen Retention:   Samples Without DNA
Maternal peripheral blood and umbilical cord blood


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382601


Contacts
Contact: Diane Gumina, MS diane.gumina@ucdenver.edu
Contact: Chanel Mansfield, BBA 303-724-6501 chanel.mansfield@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Diane Gumina, MS       diane.gumina@ucdenver.edu   
Principal Investigator: John Hobbins, MD         
Sub-Investigator: Henry Galan, MD         
Sub-Investigator: Mike Zaretsky, MD         
Sub-Investigator: Shane Reeves, MD         
Sub-Investigator: Bettina Cuneo, MD         
Sub-Investigator: Lisa Howley, MD         
Sub-Investigator: David Mirsky, MD         
Sub-Investigator: Mariana Meyers, MD         
Sub-Investigator: Jennifer Armstrong-Wells, MD         
Sub-Investigator: Laura Brown, MD         
Sub-Investigator: Miriam Post, MD         
Sub-Investigator: Sean Deoni, MD         
Sponsors and Collaborators
University of Colorado, Denver
The Perelman Family Foundation
Investigators
Principal Investigator: John Hobbins, MD University of Colorado, Denver

Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02382601     History of Changes
Other Study ID Numbers: 14-1360
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by University of Colorado, Denver:
Pregnancy
IUGR
Small for gestational age

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes