Small for Gestational Age

This is a multicenter, randomized, open-label, active-controlled Phase III clinical study to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of once-weekly PEG-hGH injection compared with once-daily hGH injection in the treatment of prepubertal children with short stature due to small for gestational age (SGA) who have not received prior growth hormone treatment. Eligible subjects will be randomized in a 2:1 ratio to receive either PEG-hGH injection 0.3 mg/kg/week (experimental group) or hGH injection 0.066 mg/kg/day (active comparator group) for 52 weeks, followed by a 52-week extension period in which all subjects receive PEG-hGH injection 0.3 mg/kg/week. The primary endpoint is annualized height velocity (AHV) at Week 52.

This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.

Periodontal disease in pregnant women has been implicated as a potential risk factor for adverse pregnancy outcomes, including being born preterm, small-for-gestational age, and/or low birth weight. Infants who have at least one of these outcomes, known as small vulnerable newborns (SVN)), are at increased risk of early death and poor infant growth and development. Rigorous, high-quality randomized trials are needed to evaluate whether improving the periodontal health of pregnant women can reduce the risk of adverse pregnancy outcomes in areas like South Asia, where these outcomes are common and neonatal mortality remains high. This study is a community-based, randomized controlled trial (n=2,280) to evaluate a package of oral health interventions delivered to pregnant women in the first trimester until delivery on the incidence of SVNs in rural Sarlahi District, Nepal. The intervention package will include a daily antiseptic oral rinse and intensive oral hygiene education and instruction. Both intervention and control groups will be provided a manual toothbrush and toothpaste. The investigators will determine intervention effects on incidence of SVNs and individual outcomes of preterm birth, small-for-gestational age, and low birth weight. In a biospecimen sub-study (n=200), the investigators will collect venous blood, gingival crevicular fluid, and plaque in early and late pregnancy to explore relationships between subgingival inflammation, systemic inflammation, and SVN types and other adverse pregnancy outcomes. If efficacious, a low-cost package of oral health interventions - including an antiseptic oral rinse, intensive oral hygiene education and instruction, and provision of a manual toothbrush and toothpaste - could improve maternal and newborn outcomes at this critical time of growth and development.

This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in children with short stature born small for gestational age (SGA).It plans to enroll 141 children with short stature born small for gestational age (SGA), who will be stratified by gender and age and randomized in a 1:1:1 ratio to either Experimental Group 1, Experimental Group 2, or the Active Control Group. All participants will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). Safety and efficacy will be comprehensively evaluated.

Fetal growth restriction during pregnancy represents one of the biggest risk factors for stillbirth (Gardosi et al, 2013), with 'about one in three term, normally formed antepartum stillbirths are related to abnormalities of fetal growth' (MBRRACE, 2015). Therefore, antenatal detection of growth restricted babies is vital in order to be able to monitor and decide the appropriate delivery timing. However, antenatal detection of SGA babies has been poor, varying greatly across trusts in England in those that calculate their rates (NHS England, 2016). Most trusts do not calculate their detection rates and rates are therefore unknown. It is estimated that routine NHS care detects only 1 in 4 growth restricted babies (Smith, 2015). Oxford University Hospitals NHS Foundation Trust, in partnership with the Oxford Academic Health Science Network (AHSN) has introduced a clinical care pathway (the Oxford Growth Restriction Pathway (OxGRIP)) designed to increase the rates of detection of these at risk babies. The pathway is intended to increase the identification of babies who are at risk of stillbirth, in order to try to prevent this outcome, whilst making best usage of resources, and restricting inequitable practice and unnecessary obstetric intervention. It has been developed with reference to a body of research, however, the individual parts of care provided have not been put together in a pathway in this manner before. Therefore it is important to examine whether the pathway meets its goals of improving outcomes for babies in a 'real world' setting. The principles of the pathway are 1. A universal routine scan at 36 weeks gestation. 2. Additional growth scans at 28 and 32 weeks gestation based on a simplified assessment of risk factors and universal uterine artery Doppler at 20 weeks gestation. 3. Assessment of further parameters other than estimated fetal weight associated with adverse perinatal outcome (eg growth velocity, umbilical artery Doppler and CPR). The clinical data routinely collected as a result of the introduction of the pathway offers a valuable and unique resource in identifying and analysing in the effects of the pathway on its intended outcomes and also in investigating and analysing other maternal, fetal and neonatal complications and outcomes, establishing normal / reference ranges for ultrasound values.

Low blood sugar in newborns is common and if prolonged or untreated may place them at increased risk for later learning and behavior challenges. Currently, we measure newborn glucose with at least four painful heel sticks, missing one in four episodes of low blood sugar. The goal of this observational study is to develop a less invasive approach to glucose monitoring, developed for newborns, that provides more frequent glucose measurements. We will also measure how a pregnant woman's health impacts newborn glucose, and how newborn glucose is linked to brain oxygen saturation and development.

The purpose of this study is to evaluate the long-term safety and effectiveness of growth hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS (Idiopathic Short Stature).