Clinical trials: ROP Examination
Premature, Retinopaty of Prematurity
Pain and Comfort in the Examination of Retinopathy of Prematurity
This study is planned to be conducted in the Neonatal Intensive Care Unit using a double-blind, parallel-group, randomised controlled design to determine the effect of a pacifier dipped in breast milk on pain and comfort during…
- Trial name
- NCT07334652
- Testing
- Pacifier group
- Where
- Turkey (Türkiye)
- Volunteers
- 56 people
- Sponsor
- Ataturk University
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
Retinopathy of Prematurity, Pain, Procedural
Clonidine as Pain Relief During ROP Eye Examinations
Preterm infants are at risk of developing ROP (retinopathy of prematurity), an eye condition that can cause blindness. Preterm infants born before gestation week (GA) 30 are therefor screened regularly with eye examinations.
- Conditions
- Retinopathy of Prematurity, Pain, Procedural, Premature Infant Disease
- Trial name
- cloROP (NCT04902859)
- Testing
- Clonidine Oral Liquid Product, Sterile water
- Where
- Sweden
- Volunteers
- 50 people
- Sponsor
- Region Örebro County
Breastfeeding, Retinopaty of Prematurity
The Effect of Breast Milk on Pain and Stress
This study aimed to examine the effect of breast milk on pain and stress during Retinopathy of Prematurity (ROP) examinations. This randomized controlled experimental study was conducted with premature infants (N = 154)…
- Conditions
- Breastfeeding, Retinopaty of Prematurity, Pain, Stress
- Trial name
- NCT07127679
- Testing
- Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As par
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people
- Sponsor
- Ege University
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
Retinopathy of Prematurity, Pain
The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination
Although screening exams for retinopathy of prematurity (ROP) prevent blindness they are physiologically stressful for infants. The investigators postulate that photosensitivity during mydriasis contributes to post-examination…
- Conditions
- Retinopathy of Prematurity, Pain, Premature Infant, Retinal Disease
- Trial name
- MASK-ROP (NCT03824782)
- Testing
- Phototherapy Mask
- Where
- Canada
- Volunteers
- 51 people
- Sponsor
- Sunnybrook Health Sciences Centre
Infant, Newborn, Disease, Pain
Eye Shields for Infants After Dilated Exam
The eyes of hospitalized infants are often assessed by dilated exam, and there is evidence that infants experience post-exam stress.
- Conditions
- Infant, Newborn, Disease, Pain, Retinopathy of Prematurity, Eye Diseases
- Trial name
- NCT04519060
- Testing
- phototherapy eye shield
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Children's Hospital Los Angeles
Apnea of Prematurity, Retinopathy of Prematurity
Use of Sucrose to Relieve Pain During Eye Exams in Infants
The purpose of this study is to see if an oral sucrose solution can comfort premature infants during their necessary eye exams. The investigators believe that the use of this solution prior to the eye exams will lead to a…
- Conditions
- Apnea of Prematurity, Retinopathy of Prematurity, Pain
- Trial name
- NCT00161694
- Testing
- sucrose solution
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Weill Medical College of Cornell University
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
Drug Safety
Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
The goal of this study is to learn about the safety and effectiveness of intranasal midazolam in newborns and infants born prematurely, undergoing Retinopathy of Prematurity (ROP) screening.
- Trial name
- NCT06889376
- Testing
- Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.
- Where
- Poland
- Volunteers
- 40 people
- Sponsor
- Polish Mother Memorial Hospital Research Institute
Retinopathy of Prematurity
The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial
Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure.
- Trial name
- NCT01872871
- Testing
- Paracetamol
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Dr. Sami Ulus Children's Hospital
Pre-Term
Optos Versus Indirect Ophthalmoscopy for ROP Screening Examination (Optos vs BIO Study)
ROP is a preventable cause of blindness in premature infants. It is routinely screened for by using an indirect ophthalmoscope, a scleral depressor, and a condensing lens.
- Trial name
- NCT04292015
- Testing
- Optos ultra-widefield retinal imaging (Optos California)
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
Retinopathy of Prematurity
Pain Response During Examination for Retinopathy of Prematurity
Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for ROP at 6 weeks old.
- Trial name
- ROP (NCT00648687)
- Testing
- suck 12.5% dextrose in water 5 minutes before the procedure
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- National Bioethics Commission of Brazil
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
Pain, Stress
Pain and Stress Assessment and ROP Screening
The study will measure the effects of eye exams on markers of stress in the urine. In addition, measurements will be taken to show the effects of stress on brain activity, O2 sats, and blood flow.
- Trial name
- NCT02415205
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Loma Linda University
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
Premature Infant, Retinopaty of Prematurity
Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants
This study will be conducted to determine the effect on pain and vital signs of multiple nonpharmacological methods used in preterm infants during the examination for retinopathy of prematurity (ROP).
- Conditions
- Premature Infant, Retinopaty of Prematurity, Pain Management
- Trial name
- NCT06959290
- Testing
- Multiple nonpharmacological methods, Routine Treatment
- Where
- Turkey (Türkiye)
- Volunteers
- 24 people
- Sponsor
- Istanbul Medeniyet University
Retinopathy of Prematurity, Mydriasis
The Effects of Mydriatic Eye Drops in Retinopathy of Prematurity Examinations
Retinopathy of prematurity (ROP) is a retinal disorder of preterm neonates and a potential cause of blindness. As early diagnosis and treatment preserve vision, very low birth weight infants must be screened for ROP.
- Conditions
- Retinopathy of Prematurity, Mydriasis, Neonatal Disease, Analgesic Adverse Reaction
- Trial name
- NCT05880433
- Testing
- NIRS(INVOS 5100; Covidien Somanetics, Troy, MI
- Where
- Turkey (Türkiye)
- Volunteers
- 62 people
- Sponsor
- Istanbul Training and Research Hospital
Retinopathy of Prematurity
Inhaled Nitrous Oxide for Pain Relief During Eye Exam in the Pre-term Infant
The primary objective of the proposed study is to show that inhaled equimolar mixture of oxygen and nitrous oxide (EMONO) will reduce pain associated with retinal exam in the preterm infant, as compared to the current standard…
- Trial name
- NCT00623220
- Testing
- N2O, oxygen
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Nabeel Ali
Retinopathy of Prematurity, Newborn
The Effect of Different Music Listened During Retinopathy Examination to Premature Infants
Retinopathy of Prematurity (ROP); It is a disease of premature and low birth weight infants, characterized by incomplete vascularization of the retina, etiology and pathogenesis of which is unknown, and causes vision loss.
- Trial name
- NCT05967572
- Testing
- Research processes;
- Where
- Turkey (Türkiye)
- Volunteers
- 84 people
- Sponsor
- Necmettin Erbakan University