View clinical trials related to Small for Gestational Age.
Filter by:The purpose of this retrospective pilot study is to address the effect that obesity, in the absence of other comorbidities, has on birth weight. We wish to determine if obesity is a risk factor for small for gestational age (SGA) or intrauterine growth restricted (IUGR) infants in our clinic population. There have been many studies linking maternal obesity with fetal macrosomia, defined as fetal birth weight greater than 4500 grams. However, we have noted that a percentage of our obese patient population has delivered either an SGA or IUGR infant. SGA refers to a constitutionally small infant weighing less than the 10th percentile for age. This refers to a genetically normal infant. IUGR refers to a fetus whose growth has been restricted by influences other than normal genetics. Our study population will consist of all women over the age 18 who delivered a term infant either by vaginal delivery or cesarean section at Tulsa Regional Medical Center between July 1st 2004 and December 31st 2005. The diagnosis of obesity will be based upon a Body Mass Index (weight in kilograms/height in meters squared) of thirty or greater. We will look at the infant birth weight as recorded in the patient's chart. We will define SGA or IUGR as birth weight less than the 10th percentile for gestational age as defined previously. The control group will consist of women meeting the same criteria except they will have a BMI less than thirty but greater than 19.8 as low maternal weight is also a risk factor for IUGR. We will compare the average birth weight and the rates of SGA/IUGR infants between the two groups and analyze using the chi-squared method of analysis.
Serum insulin-like growth factor-I (IGF-I) measurements have been shown to correlate well with growth hormone action and effect, and recent data show that serum IGF-I may be related to safety and efficacy of growth hormone (GH) treatment in patients. Some studies indicate that high IGF-I levels are associated with increased cancer risk, and low IGF-I levels are associated with increased risk for cardiovascular disease. Studies in children also show that the serum IGF-I level is correlated with the change in height score achieved (that is, the higher the IGF-I level, the greater the gain in height). Pediatric endocrinologists have therefore begun to use serum IGF-I levels, in addition to growth rate and weight gain, to adjust the GH dose in treated children. Although monitoring of serum IGF-I levels is becoming standard of care in patients begin treated with GH, there are few guidelines regarding the actual logistics of adjusting GH dose. As serum IGF-I level has been linked to both safety and efficacy of GH treatment, the ideal practice would be to maintain serum IGF-I levels within a certain target range. The overall goal of our study is to construct a mathematical model which predicts the change in GH dose necessary to achieve a desired change in IGF-I level. Hypotheses to be tested by our study include the following: IGF-I measurement has a role in optimization of GH therapy; GH dose change to achieve IGF-I changes are predictable; and gender and puberty affect the relationship between dose change and target IGF-I changes.
This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.
This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan. In the main period, subjects will receive either active treatment for 104 weeks (two dosing regimens) or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks (two years) will continue with the same treatment for further 156 weeks (three years) while those subjects who received no treatment for 52 weeks (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In total, subjects participate in trial for 260 weeks (five years). Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517.
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.