[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-for-gestational-age-infant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-for-gestational-age-infant":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100442620","fetal-growth-abnormality-detection-trial-100442620",false,"NCT05043753","\"Fetal gRowth AbnorMality dEtection Trial\"","Department of Obstetrics and Gynecology Modena Policlinico Hospital Vial Del Pozzo 71, 41125 Modena","FRAME","Inclusion Criteria:\n\n* Maternal age ≥ 18 years and ability to give informed consent.\n* Singleton gestation\n* Ultrasound examination that confirms or revises the EDD before 14 weeks of gestational age\n* Gestational age ≥ 35 weeks' gestation\n* Normal aneuploidy screening (1st trimester screening, 2nd trimester screening, integrated screening, NIPT) when performed\n* Spontaneously conceived pregnancy (i.e the current pregnancy is not the result of in vitro fertilization)\n\nExclusion Criteria:\n\n* Fetal chromosomal or genetic abnormalities if invasive prenatal diagnosis is performed\n* Fetal malformations or soft markers identified on fetal anatomy survey\n* Episodes of uterine bleeding after 24 weeks gestation. Unobserved self-reported bleeding with confirmed intact pregnancy on ultrasound after the bleeding episode is not an exclusion criteria.\n* Uterine\u002Fplacental abnormalities including uterine malformations (i.e bicornuate uterus, didelpus uterus), abnormal placentation (placenta previa, accreta, percreta), uterine fibroids.\n* Cerclage in the current pregnancy\n* History of intrauterine fetal demise\n* History of fetal growth restriction or birth weight \\> 4Kg in a previous pregnancy\n* Fetal isoimmunization or alloimmunization\n* Fetal demise in previous pregnancies\n* Cancer (including melanoma but excluding other skin cancers). Dysplastic or pre-neoplatic conditions such as cervical intraepithelial neoplasia are admissible.\n* Endocrine disease including thyroid disease (recently diagnosed or whose medication dose is not stable), adrenal disease, diabetes mellitus (pregestational and gestational).\n* Renal disease with altered renal function (creatinine \\> 0.9, proteinuria \\> 300 mg\u002F24 hour)\n* Epilepsy or other seizure disorder\n* Any collagen disease (lupus erythematosus, scleroderma, etc.)\n* Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes). Liver disorders accounting for cholestasis (including cholestasis of pregnancy) if diagnosed prior to enrollment.\n* Hematological disorder including alloimmune and isoimmune thrombocytopenia but excluding mild iron deficiency anemia (Hb \\> 9 gm\u002Fdl). Patients with sickle cell disease are excluded.\n* Chronic pulmonary disease including asthma requiring regular use of medication and active TB. An asthma inhaler used on an as needed basis for a cold or an asthma attack is not considered regular use.\n* Heart disease except mitral value prolapse not requiring medication\n* Cardiovascular disorders: chronic hypertension, gestational hypertension or preeclampsia diagnosed prior to enrollment\n* Infectious diseases: HIV, CMV, toxoplasmosis, parvovirus B19, HBV, HCV\n* Chronic treatments with medications such as aspirin, steroids, anti-hypertensive agents, immunosuppressants, antineoplastic drugs.\n* Prior laparoscopic or open uterine surgeries where the uterine cavity was entered (such as myomectomies)\n* Resectoscopic myomectomies (prior resectoscopic polypectomies are not contraindications)\n* Prior classical cesarean deliveries.",true,"FEMALE","18 Years","45 Years",{"count":22,"type":23},1566,"ESTIMATED","INTERVENTIONAL",[26],"NA","The present trial intends to assess the diagnostic accuracy of symphysis fundal height (SFH) as opposed to SFH combined with point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC) in identifying small and large for gestational age infants (SGA and LGA infants) among low-risk pregnant women cared for by midwives after 35 weeks' gestation.\n\nLow risk pregnancies will be evaluated at 35-38, 40, 41, and 41+ weeks' gestation by midwives trained in SFH measurement and POC-US. Formal obstetric US performed by a perinatologist (i.e high risk obstetrician) will be performed in case SFH and\u002For POC-US suspect fetal growth or amniotic fluid abnormalities. Prenatal evaluations will be compared to actual birthweights.",[29,30,31,32],"Small for Gestational Age Infant","Large for Gestational Age Infant","Oligohydramnios","Polyhydramnios","RECRUITING","2024-12-04",{"date":36,"type":37},"2024-12-09","ACTUAL",{"date":39,"type":37},"2024-01-20",{"date":41,"type":23},"2025-12-21",{"name":43,"class":44},"University of Modena and Reggio Emilia","OTHER",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100450326","phase-4-a-real-world-study-of-the-effect-of-early-peg-rhgh-therapy-on-cognitive-development-of-sga-infants-100450326","NCT05144035","A Real World Study of the Effect of Early PEG-rhGH Therapy on Cognitive Development of SGA Infants","Inclusion Criteria:\n\n1. Provide informed consent signed and dated by the subject's legal guardian;\n2. The subjects met the clinical diagnosis of small for gestational age infants.\n3. The age ranged from 6 months to 2 years old (including 6 months and 2 years old);\n4. Height and head circumference are lower than the reference value - 2sd (including-2sd), whose weight is lower than the 10th percentile of the reference value of normal children of the same age and sex;\n5. The total developmental quotient GQ calculated according to Griffiths mental development scale is less than 100 points (100 points) Indicates that the developmental age is consistent with the physiological age);\n6. Birth gestational age ≥ 37 weeks and \\\u003C 42 weeks, single birth and non test tube baby;\n7. Symmetrical SGA: birth weight index \\> 2.0 (gestational age = 37 weeks), or \\> 2.2 (gestational age \\> 37 weeks) . Weight index \\[birth weight (g) × 100 \u002F birth length (CM) \\];\n8. Normal thyroid function or normal after replacement therapy;\n9. No previous rhGH treatment\n\nExclusion Criteria:\n\n1. Patients with abnormal liver and kidney function (ALT \\> 2 times the upper limit of normal value, Cr \\> the upper limit of normal value);\n2. Severe familial dwarfism (father height \\\u003C 155cm or mother height \\\u003C 145cm);\n3. Definite neurological defects and \u002F or severe neurodevelopmental retardation (the total development quotient calculated according to Griffiths mental development scale is less than 70), definite syndrome affecting cognitive development; Severe perinatal complications (such as severe asphyxia, sepsis, necrotizing enterocolitis, respiratory distress syndrome with long-term sequelae);\n4. Genetic metabolic diseases (such as congenital hypothyroidism, phenylketonuria, methylmalonic acidemia);\n5. Congenital skeletal dysplasia, or moderate or above scoliosis (or scoliosis ≥ 15 °) requiring treatment or claudication;\n6. Short stature with other definite causes, such as osteochondral dysplasia and Turner syndrome (TS), Noonan syndrome (NS), Prader Willi syndrome (PWS), Angelman syndrome (as), silver Russell syndrome (SRS), or other genetically confirmed syndromes (Note: diseases that meet the clinical diagnostic criteria adopt the method of clinical diagnosis; when the clinical diagnosis is difficult to be clear, or the diagnosis of the disease depends on gene screening, the method of gene diagnosis shall be supplemented \u002F adopted);\n7. patients with diabetes or fasting blood glucose are abnormal and the researchers believe that they may affect the safety of subjects.\n8. Continuous application of other hormone therapy or systemic glucocorticoid therapy for more than one month in the past 6 months (local or inhaled glucocorticoids are allowed);\n9. Patients with a history of convulsions or epilepsy, except for the relief or recovery of convulsions or epilepsy symptoms after the release of definite causes (such as high fever, calcium deficiency, brain infection, etc.);\n10. Patients with other systemic chronic diseases;\n11. Patients with confirmed tumors, or patients with family history of tumors (two or more tumor patients within three generations of immediate relatives), previous tumor history or considered as patients with high risk of tumors in combination with other information, clear syndromes with high risk of tumors (such as Bloom syndrome, Fanconi syndrome, Down syndrome, etc.);\n12. Known high allergic constitution or allergic to the test drug in this study;\n13. Those who have participated in clinical trials of other drugs within 3 months (the placebo group is not subject to this restriction);\n14. Have received drug treatment that may interfere with GH secretion or GH effect within 3 months (including but not limited to any type of recombinant human growth hormone and protein assimilation drugs (including but not limited to oxandron, danazol and stanazol) other than rhGH injection);\n15. The investigator considers that it is not suitable to be selected for this clinical trial.","ALL","6 Months","2 Years",{"count":56,"type":23},138,[58],"PHASE4","Cognitive impairment is independently related to low birth weight, low birth length and small head circumference. SGA children who have not experienced height and \u002F or head circumference catch-up have the worst cognitive function. The serum IGF-1 level of short SGA children is significantly lower than that of catch-up SGA children. This may be due to the defect of GH-IGF-1 axis, resulting in some hGH \u002F IGF-1 deficiency.\n\nGH treatment can induce catch-up growth of head circumference, especially for those with small birth head circumference, growth hormone can help to improve IQ, behavior and self cognition of children with SGA.\n\nTwo years after birth is the most critical period for children's physical, neurological, cognitive and emotional development. This study evaluated the effect of growth hormone treatment on the improvement of cognitive function and growth and development of symmetrical SGA children who did not show catch-up growth from 6 months to 2 years old.\n\nThis is an innovative study. The minimum age of previous similar studies is 19 months. The starting age of this study is 6 months, and the results are to improve the cognitive development of SGA infants. This is the first of its kind. Although the safety of growth hormone in SGA infants younger than 2 years old has not been reported, it is based on a number of studies on the application of growth hormone in infants, such as PWS and GHD, It can be expected that there will be no short-term and long-term adverse reactions.\n\nThe study was conducted in 17 hospitals led by Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology",[29,61,62],"Growth Hormone Treatment","Cognitive Developmental Disorder",[64,65,66],"SGA","PEG-rhGH","Cognitive developmental","2023-04-17",{"date":69,"type":37},"2023-04-19",{"date":71,"type":37},"2022-04-06",{"date":73,"type":23},"2026-06-30",{"name":75,"class":44},"Tongji Hospital",1]