Clinical trials: Retinopathy of Prematurity
Infant, Premature, Diseases, Bronchopulmonary Dysplasia
Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference…
- Conditions
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Infant, Newborn, Diseases
- Trial name
- NeOProM (NCT01124331)
- Testing
- Higher oxygen saturation target range (91%-95%), Lower oxygen saturation (85%-89%)
- Where
- 9 sites in Australia
- Volunteers
- 4,965 people
- Sponsor
- University of Sydney
Retinopathy of Prematurity
Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.
The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are prematurity, use of oxygen, malnutrition and oxidative stress.
- Trial name
- NCT03274596
- Testing
- Vitamin E
- Volunteers
- 90 people
- Sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Retinopathy of Prematurity
Improve Screening Criteria for Retinopathy of Prematurity in Two French Center
The aim of the study is to assess whether a delay of the first examination can be safely considered in French population. Secondary objectives are to describe retinopathy of prematurity (ROP) in a population of premature from two…
- Trial name
- DEREP3 (NCT05152862)
- Testing
- Laser, Anti VEGF
- Where
- France
- Volunteers
- 886 people
- Sponsor
- Centre Hospitalier Sud Francilien
Retinopathy of Prematurity, Pain
Acupuncture for Preterm Infants Requiring Eye-exam
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…
- Conditions
- Retinopathy of Prematurity, Pain, Acupuncture, Premature Infant
- Trial name
- MAGNIFIC-ROP (NCT03650621)
- Testing
- Magnetic acupuncture, stickers (magnets removed)
- Where
- 3 sites in Australia, Canada and 1 more
- Volunteers
- 100 people
- Sponsor
- University of Alberta
Anemia of Prematurity
Premature Infants in Need of Transfusion (PINT)
Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity…
- Trial name
- NCT00182390
- Testing
- Red blood cell transfusion
- Where
- 10 sites in United States, Australia and 1 more
- Volunteers
- 424 people
- Sponsor
- McMaster University
Retinopathy of Prematurity Both Eyes, Retinal Disease
Safety and Efficacy of 18 mm Short Vitrectomy Probe for Pediatric Vitreoretinal Surgeries
This study aims to study the safety and efficacy of using an 18 mm short vitrectomy probe for pediatric vitreoretinal surgeries and to investigate the surgeon's comfort and reliability of using the shorter probe.
- Conditions
- Retinopathy of Prematurity Both Eyes, Retinal Disease, Persistent Fetal Vasculature, Coats Disease
- Trial name
- NCT06520410
- Testing
- Pars plana vitrectomy with a 18 mm short vitrector
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Chang Gung Memorial Hospital
Retinopathy of Prematurity
Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP)
The purpose of this study is to determine whether a single intravitreal (into the gel of the eye) injection of Avastin 0.625mg or 0.75mg is equivalent (non-inferior) to treatment with standard of care laser in infants with Type I…
- Trial name
- BLOCK-ROP (NCT01232777)
- Testing
- Bevacizumab
- Where
- 19 sites in United States, Canada
- Sponsor
- Vision Research Foundation
Retinopathy of Prematurity, Microbiome
The Analysis of Association of Retinopathy of Prematurity, Gut Microbiome Profile, and Systemic Inflammation
Study Aims 1. Understanding the gut microbiome profile in very low birth weight infants with or without ROP. The onset and aggravation of ROP and their relationship with gut microbiome will be examined. 2.
- Trial name
- NCT05144282
- Testing
- intravitreal injection of anti VEGF, laser photocoagulation
- Where
- Taiwan
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Retinopathy of Prematurity
European Disease Registry on Retinopathy of Prematurity (ROP)
The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective…
- Trial name
- EU-ROP (NCT04939571)
- Testing
- Registry of preterm born infants with treatment-requiring ROP
- Where
- 59 sites in Austria, Bulgaria and 10 more
- Volunteers
- 3,000 people
- Sponsor
- University Medicine Greifswald
Retinopathy of Prematurity
REDEXAM - Reducing Painful Eye Examinations in Preterm Infants
More than 8000 babies born >8 weeks early or weighing less than 1500g at birth in the United Kingdom annually are at risk of a serious eye problem - retinopathy of prematurity (ROP).
- Trial name
- REDEXAM (NCT01861470)
- Where
- United Kingdom
- Volunteers
- 500 people
- Sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
Infant, Very Low Birth Weight
Urine VEGF Levels in Very Low Birth Weight (VLBW) Infants
VLBW infants are at risk of developing retinopathy of prematurity (ROP). In the first phase of ROP there is a down-regulation of retinal VEGF-expression because of postnatal relative hyperoxia, followed by an upregulation of VEGF…
- Trial name
- NCT00799721
- Where
- Germany
- Volunteers
- 160 people
- Sponsor
- Charite University, Berlin, Germany
Retinopathy of Prematurity, Genetic Polymorphism
Genetic Polymorphism and Retinopathy of Prematurity: Correlation of Clinical Presentations and Severity
Study Aim and Goals 1. Evaluate the correlation between genetic polymorphism and ROP development 2. To study the possibility if there are any specific genetic polymorphisms that lead to poor outcome or recurrence of ROP after…
- Trial name
- NCT05132257
- Testing
- Severe ROP
- Where
- Taiwan
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Retinopathy of Prematurity
Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity
The purpose of this study is to evaluate whether docosahexaenoic acid given by enteral feeding prevent retinopathy of prematurity and/or diminish its severity in preterm infants.
- Trial name
- NCT02683317
- Testing
- docosahexaenoic acid, sunflower oil
- Where
- Mexico
- Volunteers
- 110 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Retinopathy of Prematurity (ROP)
IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
To compare the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for gestational age at birth while confirming the dose of rhIGF-1/rhIGFBP-3 is safe and efficacious.
- Trial name
- NCT01096784
- Testing
- rhIGF-I/rhIGFBP-3
- Where
- 24 sites in United States, Italy and 4 more
- Volunteers
- 121 people
- Sponsor
- Shire
Retinopathy of Prematurity
A Study Investigating Whether Low Dose Eyedrops for Pupil Dilation is as Effective and Safe as Standard Dose Eyedrops in Examination for Retinopathy of Prematurity.
A prospective, randomized controlled study was conducted from August, 2022 to March, 2023 in the neonatal intensive care unit in Queen Mary Hospital, Hong Kong.
- Trial name
- NCT06288321
- Testing
- Microdrop Mydrin-P, Standard Mydrin-P
- Where
- Hong Kong
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
Retinopathy of Prematurity
Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening
Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care Unit.
- Trial name
- NCT00921544
- Testing
- Sucrose, Sterile water
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- Coombe Women and Infants University Hospital
Retinopathy of Prematurity
Infant-parent Skin-to-skin Contact During Screening for Retinopathy
Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced.
- Trial name
- NCT02780544
- Testing
- skin-to-skin contact, incubator, Sucrose
- Where
- Norway
- Volunteers
- 34 people
- Sponsor
- St. Olavs Hospital
Premature Retinopathy, Visual Impairment
Evaluation of Visual - Motor Development in Children With Retinopathy of Prematurity
The aim of this study was to investigate the eye structure, visual impairment, visual motor development and motor coordination of children between 2-6 ages that had applied to diod laser photocoagulation and intravitreal anti …
- Conditions
- Premature Retinopathy, Visual Impairment, Motor Delay
- Trial name
- NCT03865134
- Testing
- Snellen Test, Autorefractometer, Titmus Stereo Fly Test
- Where
- Turkey (Türkiye)
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Istanbul Medipol University Hospital
Investigate the Efficacy of Sucrose During Eye Examination
Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination for Retinopathy of Prematurity
Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to…
- Trial name
- NCT01811979
- Testing
- Oral sucrose solution, Steril water
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Dr. Sami Ulus Children's Hospital
Pain, Retinopathy of Prematurity
Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination
The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn.
- Conditions
- Pain, Retinopathy of Prematurity, Premature Baby 26 to 32 Weeks, Premature Baby 33 to 36 Weeks
- Trial name
- NCT06348641
- Testing
- baby massage
- Volunteers
- 60 people
- Sponsor
- Nurgül Tekin