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| Name | Class |
|---|---|
| The Perelman Family Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the sequence of neurological and cardiovascular events defining early and late IUGR pathogenesis, respectively | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate in utero adaptations in early and late IUGR, to infant and early childhood neurodevelopment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Peek, BS | Contact | emma.peek@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| John Hobbins, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23969791 | Background | Barker ED, McAuliffe FM, Alderdice F, Unterscheider J, Daly S, Geary MP, Kennelly MM, O'Donoghue K, Hunter A, Morrison JJ, Burke G, Dicker P, Tully EC, Malone FD. The role of growth trajectories in classifying fetal growth restriction. Obstet Gynecol. 2013 Aug;122(2 Pt 1):248-254. doi: 10.1097/AOG.0b013e31829ca9a7. | |
| 8885925 | Background |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| D001800 | Blood Specimen Collection |
| C513798 | PEAPOD protein, Arabidopsis |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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Maternal peripheral blood and umbilical cord blood
| 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. |
|
|
| Pediatric heart ultrasound | Radiation | Children will have ultrasounds of their hearts during follow-up visits. |
|
| Correlate in utero adaptations in early and late IUGR, to infant and early childhood cardiovascular outcomes | 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 | 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 | 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 |
| Mongelli M, Gardosi J. Reduction of false-positive diagnosis of fetal growth restriction by application of customized fetal growth standards. Obstet Gynecol. 1996 Nov;88(5):844-8. doi: 10.1016/0029-7844(96)00285-2. |
| 20435282 | Background | Cruz-Martinez R, Figueras F, Hernandez-Andrade E, Puerto B, Gratacos E. Longitudinal brain perfusion changes in near-term small-for-gestational-age fetuses as measured by spectral Doppler indices or by fractional moving blood volume. Am J Obstet Gynecol. 2010 Jul;203(1):42.e1-6. doi: 10.1016/j.ajog.2010.02.049. Epub 2010 May 1. |
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| 23775904 | Background | Acharya G. Measurement of atrioventricular annular plane displacement has been revived: will it prove to be useful in assessing fetal cardiac function? Ultrasound Obstet Gynecol. 2013 Aug;42(2):125-9. doi: 10.1002/uog.12542. No abstract available. |
| 23893598 | Background | Kiserud T. Re: umbilical vein flow and perinatal outcome in term small-for-gestational-age fetuses. M. Parra-Saavedra, F. Crovetto, S. Triunfo, S. Savchev, G. Parra, M. Sanz, E. Gratacos and F. Figueras. Ultrasound Obstet Gynecol 2013; 42: 189-195. Ultrasound Obstet Gynecol. 2013 Aug;42(2):130. doi: 10.1002/uog.12553. No abstract available. |
| 21324404 | Background | Odibo AO, Zhong Y, Longtine M, Tuuli M, Odibo L, Cahill AG, Macones GA, Nelson DM. First-trimester serum analytes, biophysical tests and the association with pathological morphometry in the placenta of pregnancies with preeclampsia and fetal growth restriction. Placenta. 2011 Apr;32(4):333-8. doi: 10.1016/j.placenta.2011.01.016. Epub 2011 Feb 13. |
| 23890468 | Background | Hafner E, Metzenbauer M, Stumpflen I, Waldhor T. Measurement of placental bed vascularization in the first trimester, using 3D-power-Doppler, for the detection of pregnancies at-risk for fetal and maternal complications. Placenta. 2013 Oct;34(10):892-8. doi: 10.1016/j.placenta.2013.06.303. Epub 2013 Jul 24. |
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| 21557369 | Background | Figueras F, Cruz-Martinez R, Sanz-Cortes M, Arranz A, Illa M, Botet F, Costas-Moragas C, Gratacos E. Neurobehavioral outcomes in preterm, growth-restricted infants with and without prenatal advanced signs of brain-sparing. Ultrasound Obstet Gynecol. 2011 Sep;38(3):288-94. doi: 10.1002/uog.9041. Epub 2011 Aug 10. |
| 19035538 | Background | Eixarch E, Meler E, Iraola A, Illa M, Crispi F, Hernandez-Andrade E, Gratacos E, Figueras F. Neurodevelopmental outcome in 2-year-old infants who were small-for-gestational age term fetuses with cerebral blood flow redistribution. Ultrasound Obstet Gynecol. 2008 Dec;32(7):894-9. doi: 10.1002/uog.6249. |
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| 11039352 | Background | Simon EM, Goldstein RB, Coakley FV, Filly RA, Broderick KC, Musci TJ, Barkovich AJ. Fast MR imaging of fetal CNS anomalies in utero. AJNR Am J Neuroradiol. 2000 Oct;21(9):1688-98. |
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| 25158601 | Background | Chawengsettakul S, Russameecharoen K, Wanitpongpan P. Fetal cardiac function measured by myocardial performance index of small-for-gestational age fetuses. J Obstet Gynaecol Res. 2015 Feb;41(2):222-8. doi: 10.1111/jog.12508. Epub 2014 Aug 27. |
| 25463640 | Background | Mailath-Pokorny M, Worda K, Schmid M, Polterauer S, Bettelheim D. Isolated single umbilical artery: evaluating the risk of adverse pregnancy outcome. Eur J Obstet Gynecol Reprod Biol. 2015 Jan;184:80-3. doi: 10.1016/j.ejogrb.2014.11.007. Epub 2014 Nov 20. |
| D055585 |
| Physical Phenomena |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |