7 Clinical Trials for Various Conditions
Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton pregnancies, in 9.1% of all twins and 9.9% of monochorionic twins. IUGR in monochorionic twins typically affects only one of the fetuses (selective IUGR or SIUGR). Spontaneous demise of the SIUGR twin can occur, and may result in concomitant demise (up to 40% risk) or severe neurologic handicap (up to 30% risk) of the other twin. These complications result from exsanguination of the appropriately grown (AGA) twin into the demised SIUGR twin through placental vascular communications. Because the adverse effects to the AGA twin of the spontaneous demise of the SIUGR twin are mediated through placental vascular anastomoses, we have proposed obliterating such anastomoses via endoscopic fetal surgery. We have developed a technique that allows us to identify the vascular anastomoses present in monochorionic placentas. Briefly, deep AV communications are identified on the surface of the placenta by noting that the terminal end of the artery of one of the fetuses does not have a corresponding returning vein to the same fetus. We have speculated that the separation of the circulations may be of benefit in monochorionic twins affected by SIUGR by preventing the adverse effects that may result from the spontaneous demise of the IUGR twin. Our goal is to evaluate with a randomized clinical trial the outcome of SIUGR managed either expectantly or with SLPCV. Study procedures will begin with confirmation of the diagnosis and screening criteria at the Qualified Clinical Center. The patient will sign the appropriate consents and then be randomized to her treatment group. Enrollment data will be submitted to the research coordinator in Coordinating Center in Tampa. Expectant management patients will be treated by the referring physicians. Laser patients will be treated at Coordinating Center in Tampa General Hospital or qualified laser center. They may return to the referring center for follow-up. After delivery, outcome data will be sent to the research coordinator in Coordinating Center in Tampa.
The purpose of the study is to learn more about the development of small for gestational age (SGA) preterm infants and whether focusing on the infant's behavior has a positive effect on outcome. The study hypotheses state: 1) High risk severely SGA preterm infants will profit from detailed neuropsychological assessment, psychoeducational recommendations and practical guidance for caregiving, as well as formal educational and emotional support for the family and the professional care team. 2) Neuropsychological education and guidance for community-based early intervention providers caring for SGA preterm infants after their discharge is effective in promoting improved outcome.
OBJECTIVES: I. Determine if mutations in the gene encoding the insulin-like growth factor-I receptor lead to relative insulin-like growth factor-I insensitivity and produce intrauterine growth retardation in children.
The investigators plan to identify 80 pregnant women at low risk for obstetrical complications and replace 4-5 routine third trimester visits with a structured program of home weight, blood pressure and urine protein monitoring along with regular structured phone interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is both safe and acceptable.
Fetal growth abnormalities, such as macrosomia and intrauterine growth retardation, are an important cause for increased perinatal mortality in the United States. Toward this end, accurate fetal weight determinations are very important for guiding prenatal care. Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus. This technique allows one to arbitrarily scan through a digital ultrasound volume dataset, visualize organs from different perspectives, and render anatomical features through computer processing. It also allows the retrospective measurement of distances and volumes even in the physical absence of the patient. A maximum of 400 pregnancies will be serially studied by three-dimensional ultrasound to characterize the growth of volume parameters such as the fetal thigh. This information will be applied to the Rossavik model of individualized growth assessment. The technique allows growth evaluation by comparing various ultrasound measurements or birth characteristics to the individual growth standards specified by the prediction model. Newborn infant body composition will also be studied within 48 hours of delivery. A separate cross-sectional study of up to 2,577 fetuses will allow development of birth weight prediction models based upon fetal volume measurements and further analysis of fetal growth abnormalities. Individual growth curve standards utilizing these volume parameters should allow one to evaluate deviations from expected growth or birth weight by using each fetus as its own control.
Insulin resistance is common among children with low birthweight. Moreover, growth hormone treatment for ensuing short stature also causes insulin resistance. Our objective is to examine these processes. Insulin resistance has recently been linked to the accumulation of stores of fat in muscle cells which can be measured by MRI. We hypothesize that children who are short due to low birthweight have increased muscle fat stores, but that growth hormone treatment will paradoxically reverse this association. To test this hypothesis, muscle fat stores will be measured in children who are short due to low birthweight before and after receiving growth hormone therapy. Other parameters linked to insulin resistance (glucose tolerance, blood markers, and body composition) will also be assessed. This study may lead to ways to increase growth hormone safety and dose limitations.
The objective of this pilot study is to prospectively evaluate amniotic fluid of pregnancies complicated by non-immune hydrops and severe symmetrical intrauterine growth restriction by tandem mass spectrometry for inborn errors of metabolism.