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Retinopathy of Prematurity clinical trials

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NCT ID: NCT03757871 Completed - Laser Stimulation Clinical Trials

Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera

ELAROP
Start date: March 26, 2019
Phase: N/A
Study type: Interventional

Pain management in premature infants is essential because they are exposed to repeated minor painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast, side-effect-free method, but no study exists on the contribution of acupuncture in the management of pain caused by the examination of the fundus in addition to conventional therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently effective. Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort of premature newborns when examining the fundus with a digital camera.

NCT ID: NCT03650621 Completed - Pain Clinical Trials

Acupuncture for Preterm Infants Requiring Eye-exam

MAGNIFIC-ROP
Start date: August 24, 2018
Phase: N/A
Study type: Interventional

The purpose is to investigate whether non-invasive acupuncture - NIA (i.e. acupuncture without needles) will help reduce pain for babies in the Neonatal Intensive Care Unit (NICU) during their routine weekly eye-exam for Retinopathy of prematurity. Retinopathy of prematurity (ROP) is an eye disease most commonly affecting premature babies born weighing less than 1250 grams. Retinopathy of prematurity occurs because these premature babies require oxygen because of their immature lungs. The oxygen then stimulates the growth of blood vessels in the retina, causing the retina to be detached from the eye, which causes vision impairment. To examine if the vessels grow at the back of the eye, an eye-doctor visits bi-weekly once the baby is 32 weeks corrected age to assess if the blood vessels change. If there is a lot of growth, the eye-doctor would use a laser to treat the eye to prevent further growth. During the bi-weekly eye-exam, the premature infant receives sucrose (a type of sugar) for pain management. The investigator will assess pain a premature babies experience during this exam and found that there are extremely high scores of pain despite sucrose and the investigator believe this pain and stress caused by these procedures could be reduced by adding: Magnetic Acupuncture Also, untreated pain causes stress (lower oxygen levels, higher heart rates), discomfort and poorer long term outcomes. Finding the best treatment and prevention for the pain caused by procedures in the NICU is therefore extremely important for any baby.

NCT ID: NCT03448640 Completed - Clinical trials for Retinopathy of Prematurity

Efficacy of Mydriatic Drops in Premature Infants

Start date: January 15, 2016
Phase: N/A
Study type: Observational

Because of the neonatologists reported that some infants had suffered from vomiting, bradycardia, hypotonia, and aspiration risk about 30-60 minutes after the fundus examination in the intensive care unit. The investigators observed the pupil dilation effects and side effects of tipple instillation of phenylephrine 2.5% plus tropicamide 0.5% ophthalmic drop combination which the investigators routinely used in ROP examination.

NCT ID: NCT03347799 Completed - Clinical trials for Retinopathy of Prematurity

WINROP Algorithm Validation for Retinopathy Screening in a Cohort of Premature Infants

WINROP
Start date: July 1, 2012
Phase:
Study type: Observational

When a child was born too early, it is more likely to develop an alteration of its visual function than in the case of term birth. Significant visual disturbances are found in 3% of children born prematurely, but visual impairment can be very severe, up to the loss of vision in case of retinopathy of prematurity (ROP) in the most immature infants. The introduction of screening surveillance systems, such as WINROP software, might reduce the need for stressful eye examination in low risk neonates. This retrospective study aimed at validating the WINROP algorithm in a cohort of premature infants, born below 32 weeks of gestation, who had systematic eye examination for ROP screening over 4 year period.

NCT ID: NCT03334513 Completed - Clinical trials for Retinopathy of Prematurity

Refractive Error and Biometry in Retinopathy of Prematurity

Start date: April 1, 2011
Phase: N/A
Study type: Observational

The investigators compared long-term refractive and biometric outcomes in children with retinopathy of prematurity who received two different anti-vascular endothelial growth factor agents.

NCT ID: NCT03274596 Completed - Clinical trials for Retinopathy of Prematurity

Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.

Start date: March 1, 2013
Phase: N/A
Study type: Interventional

The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are prematurity, use of oxygen, malnutrition and oxidative stress. Vitamin E was used beforehand however its use was stopped because of its association with sepsis and enterocolitis caused by the excipient of vitamin E. The purpose of this study is to use vitamin E to prevent ROP, without the previously used excipients.

NCT ID: NCT03201588 Completed - Clinical trials for Ophthalmological Disorder

Multi-Center Study to Determine the Role of Fatty Acids in Serum in Preventing Retinopathy of Prematurity (MDM)

MDM
Start date: December 15, 2016
Phase: N/A
Study type: Interventional

The study is a Randomized Intervention, Multi-Center Study to Determine the Role of Fatty Acids in Serum and Breast Milk in preventing Retinopathy of Prematurity Subjects who meet all inclusion and none of the exclusion criteria will be enrolled into the study. Upon entry into the study, subjects will be randomized and given a unique subject number. A randomized intervention study of 105+105 (number based on power analysis regarding up to date ROP frequency, see 5.1 and 11.1) infants without major malformations born with a gestational age less than 28 weeks + 0 days will be performed.

NCT ID: NCT03154723 Completed - Clinical trials for Retinopathy of Prematurity

Effects of Early Vitamin A Supplementation on the Risk for Retinopathy of Prematurity in Extremely Preterm Infants

Start date: August 1, 2015
Phase: N/A
Study type: Interventional

Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and major cause of vision impairment or blindness, despite current treatment of late stage ROP. Because the visual disorders after treatment are often poor, preventive therapy for ROP is still lacking. Although ROP is a multifactorial disease, the altered regulation of vascular endothelial growth factor (VEGF) and insulin-like growth factor (IGF-1) have been implicated in the pathogenesis of ROP. Vitamin A is one of the most important micronutrients affecting the health of children. Supplementing newborn infants with vitamin A within the first 2 days of life reduced infant mortality by almost 25%, with the greatest benefit to those of low birth weight. Vitamin A has been used in this population prophylactically for chronic lung disease with the large doses and no reported significant adverse effect exists. It is suggested that vitamin A-retinoids and their active metabolite, retinoic acid (RA) have highly potent antiangiogenic activity by inhibiting VEGF expression. Vitamin A (retinol) is converted into retinoic acid in cells. However, the significance of Vitamin A administration has not been investigated to our knowledge in an experimental ROP infant. The aim of this study was to perform prospective, multicenter, randomized design to demonstrate the preventive effect of Vitamin A on ROP.

NCT ID: NCT03148132 Completed - Premature Birth Clinical Trials

VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP

Start date: May 23, 2017
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT03115255 Completed - Clinical trials for Infant, Premature, Diseases

Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

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