Clinical trials: ROP Examination
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
Premature Retinopathy, Pain, Eye
Multisensory Stimulation in Infants for Eye Examination
This study aimed to evaluate the effects of multisensory stimulation on pain and physiological parameters resulting from ROP examination in preterm newborns. It was planned as a randomized controlled trial.
- Trial name
- NCT05830409
- Testing
- Multisensorial Stimulation
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Akdeniz University
Retinopathy, Premature Retinopathy
Multisensory Stimulation Versus White Noise
This study aimed to compare the effectiveness of two interventions, white noise, and multisensory stimulation, during retinopathy examinations on premature infants.
- Trial name
- NCT05921981
- Testing
- Multisensorial Stimulation, White Noise
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people
- Sponsor
- Akdeniz University
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
Cost-effectiveness of Tele-expertise for Premature Infants for Retinopathy
The purpose of this study is to determine whether telemedicine would be as effective as having a pediatrics ophthalmologist on site for screening examination of retinopathy in premature infants and would be cost-effective.
- Trial name
- Dite-ROP (NCT02157727)
- Testing
- Infants hospitalized in health facilities performing Tele-expertise
- Where
- 2 sites in France
- Volunteers
- 843 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
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
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
ROP Examination
The Effect of Music on Pain, Comfort and Physiological Parameters During Prematurity Retinopathy Examination
It is planned to determine the effect of music during Retinopathy of Prematurity (ROP) examination on pain, comfort and physiological parameters in preterm infants.
- Trial name
- NCT05263973
- Testing
- Music
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- TC Erciyes University
Premature Retinopathy, Pain
The Effect of Ocean Sound In Premature Retinopathy Examination
Purpose: It was planned as a randomized controlled experiment in order to evaluate the effectiveness of the ocean sound on pain, comfort and physiological parameters in the NICU, Retinopathy of Prematurity (ROP) examination.
- Trial name
- NCT05203159
- Testing
- Ocean sound, Routine
- Where
- Turkey (Türkiye)
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Necmettin Erbakan University
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
Pain During ROP Exam
ROP Screening: Comparison of Pain Using Two Eyelid Retractors
Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally.
- Trial name
- NCT02152046
- Testing
- ROP exam with spring loaded retractor, ROP exam with screw retractor
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Wake Forest University Health Sciences
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
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, 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
Retinopathy of Prematurity (ROP)
The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination
The goal of this randomized controlled trial is to determine the effect of reverse kangaroo care position and ROP (Retinopathy of Prematurity) position applied during ROP examination in premature infants on pain.
- Trial name
- NCT06694103
- Testing
- Reverse Kangaroo Care Position, ROP Position
- Where
- Turkey (Türkiye)
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Sinem Basdemir
Pain
The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity
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.
- Trial name
- NCT04463927
- Testing
- non-nutritive sucking
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Adiyaman University Research Hospital
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
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, 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