Active clinical trials for "Retinopathy of Prematurity"

This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of inositol. Based on previous studies, the premise is that maintaining inositol concentrations similar to those occurring naturally in utero will reduce the rates of ROP and bronchopulmonary dysplasia in premature infants. The objective is to evaluate pharmacokinetics, safety, and clinical outcomes of multiple doses of three different dose amounts of myo-inositol (provided by Abbott Laboratories) in very low birth weight premature infants. This study will enroll an estimated 96 infants at 17 NICHD Neonatal Research Network sites. Infants will be randomly assigned to receive either 10 mg/kg of 5% inositol, 40 mg/kg of 5% inositol, 80 mg/kg of 5% inositol, or 5% glucose given in the same volumes and timings as the inositol dosage to maintain masking. Enrollees will receive their assigned dose or placebo daily, starting within 72 hours of birth, and continuing until they reach 34 weeks post-menstrual age, 10 weeks chronologic age, or until the time of hospital discharge, whichever occurs first. The study drug will be administered first intravenously; as the infants progress to full feeding, the drug will be given enterally (orally or via feeding tube). Enrollees will be seen for a follow-up examination at 18-22 months corrected age. This pilot study is in preparation for a future Phase III multi-center randomized controlled trial.

Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed in infants with retinopathy of prematurity. However, how these blood vessels form during development of the human fovea remains unclear. This research will advance our understanding of the fundamental knowledge of how the blood vessels around the fovea form in infants, and how they change in diseased states such as preterm birth or retinopathy of prematurity.

The Retinopathy of Prematurity (ROP) is one of the leading causes of blindness on the pediatric age worldwide. This pathology is characterized for arrest of the normal vascular and neuronal retina that because of pathological compensatory mechanisms results in proliferation of vascular tissue that grow in the limit between the vascular retina and the avascular retina. The ET-ROP group classified the ROP by those who need treatment immediately or those who doesn't need treatment, The classification is the following Type 1 ROP-->ROP zone I any stage with plus, zone I stage 3 without plus, zone II stage 2 y 3 with plus Type 2 ROP --> Zone 1, Stage 2 or 3 without plus, and Zone II, stage 3 without plus. The treatment is begun on patient with type 1 ROP and type 2 ROP is maintained in observation.

To determine the serum concentrations of ranibizumab and vascular endothelial growth factor (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab

Vascular Endothelial Growth Factor (VEGF) is a dimeric glycoprotein, naturally expressed in epithelial and tumor cells (1). Normal Retinal vascularization has two phases: In the first fase, cells of mesenquimatous origin form the first superficial plexus (14-21 weeks of gestation). In the second phase, denominated "angiogenesis phase", the superficial and deep capillary plexus are formed (15,20). The Retinopathy of Prematurity (ROP) was described for the first time in 1942 (4), at the present moment it is a public health problem in the developing countries. The International Classification of ROP classifies it in 5 stages, dividing it in 3 anatomical zones. It is a public health problem that continuous without having an effective prophylaxis. The early diagnosis and treatment in thresholds stages have changed the prognosis of this disease (11,12).

Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during examination for retinopathy of prematurity. Method: The study is conducted as a randomized controlled trial. The population of the study is premature newborn who treatment in a neonatal intensive unit. The premature newborns divided into two groups as an intervention and control group according to randomization. After the randomization, non-nutritive sucking is applied to the intervention group. No method is applied to the control group.

The development of the retinal vascular network is generally complete during the 3rd trimester of pregnancy but may continue during the first 15 days of life. This late maturation may cause problems in pre-term births and may result in immature vascularization of the retina, a condition called retinopathy of prematurity. Among the different factors affecting the development of the retinal vasculature, the tissue level of omega-3 polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the PUFA present in the tissues (nature of the phospholipids in their membranes). This project aims to show a possible association between levels of omega-3 PUFA and the onset of retinopathy of prematurity (ROP).

To determine the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in certain low birth-weight infants with retinopathy of prematurity (ROP) for reducing blindness from ROP. To determine the long-term outcome for eyes that had severe ("threshold") ROP, both with and without cryotherapy.

To determine the degree of VEGF in Aqueous, vitreous and SRF in patients with ROP in stage V. Verifying that it is greater to that found in healthy newborn patients with different ocular pathology.

The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.