Longitudinal Study of Intra-Uterine Growth Restriction

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.

Conditions

• IUGR
• Pregnancy

Interventions

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 including a Bayley exam, Mullen exam, Developmental Profile-3, Child Behavior Checklist, 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.

RADIATION

Pediatric heart ultrasound

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

Sponsors & Collaborators

• The Perelman Family Foundation

  collaborator UNKNOWN

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• John Hobbins, MD · University of Colorado, Denver

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• United States

Study Locations