Retinopathy of PrematurityPhase 4cloROPNCT04902859
Clonidine as Pain Relief During ROP Eye Examinations
A Phase 4 study testing Clonidine Oral Liquid Product and Sterile water in people with Retinopathy of Prematurity and Pain, Procedural, run by Region Örebro County at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 weeks to 3 months
- Conditions the study is for
- Retinopathy of Prematurity, Pain, Procedural, Premature Infant Disease
- What is being tested?
- Clonidine Oral Liquid Product and Sterile water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 25 Apr 2022to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 weeks to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born before 30 weeks gestation, informed consent from parents
Who cannot join
- Infants that have received other pain relieving or sedating drugs within 24 hours before the procedure, infants without GI-tube, infants with neurological deficit, infants with known heart arrhythmia, infants with circulatory instability (MAP below GA in weeks)
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Barn- och Ungdomskliniken, Universitetssjukhuset
Örebro
Miriam Pettersson, PhD
Emma Olsson, PhD
About this study
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. These eye examinations are painful and despite a lot of research no clear method of pain relief have been found. Since pain in the preterm infant can lead to both short- and longterm negative consequences an effective pain relief during these examinations are of importance. In this study we will investigate if Clonidine can be effective as pain-relief during ROP eye examinations.
Read the detailed description
Infants born before gestational week (GA) 30 who are cared for in neonatal units at the university hospitals in Örebro and Uppsala, Sweden can be included in the study.
According to power calculations 18 infants are needed for a power of 80% and significance level of 0.05 in order to cover for potential dropouts we plan to include 25 infants. Since the eye examinations are performed without eye speculum in Örebro and with eye speculum in Uppsala we plan to include 25 infants at each unit. The patient will be its own control and examined according to the units´ guidelines. Data will be collected during the patients´ first two eye examinations. In order to exclude potential effects of previous pain experience the order of treatment (clonidine/sterile water) will be randomized.
Sixty minutes before the first eye examination the infant will receive Clonidine or sterile water in corresponding volumes in the GI-tube by a nurse. During the examination the infant will be placed on a heated examination table and connected to an oxygen saturation probe (measuring oxygen saturation and heart rate) on one foot and electrodes for Galvanic skin response (GSR) on the other. The ophthalmologist will examine the infants eyes without eye speculum or with eye speculum on the respective unit. The infants face, oxygen saturation and heart rate will be videotaped before, during and after the examination making it possible to perform av PIPP-R pain assessment at a later time.
After the eye examination the ophtalmologist will be asked to estimate hos easy the infant was to examine by putting an "x" somewhere on a 10 centimeter long line where one end signifies "very easy to examine" and the other end signifies "very difficult to examine". The ophtalmologist can also write any other comments regarding the examination on the same form. The same procedure will be repeated during the infants´ second examination, but with the treatment he/she did not receive during the first examination.
- Being tested
- Clonidine Oral Liquid Product, Sterile water
- Keywords
- retinopathy of prematurity, procedural pain, neonatal
- Medical subject headings
- Retinopathy of Prematurity, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonidine Oral Liquid ProductDrug
Clonidine prepared from pharmacy with 20 mcg/ml concentration.
Sterile waterDrug
Sterile water used as placebo
| Study group | Role | What they receive |
|---|---|---|
| Clonidine with eye speculum | Experimental | 4 mcg/kg Clonidine given orally in GI-tube. Receives: Drug: Clonidine Oral Liquid Product |
| Placebo with eye speculum | Placebo comparator | Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube. Receives: Drug: Sterile water |
| Clonidine without eye speculum | Experimental | 4 mcg/kg Clonidine given orally in GI-tube. Receives: Drug: Clonidine Oral Liquid Product |
| Placebo without eye speculum | Placebo comparator | Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube. Receives: Drug: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIPP-R
Pain assessment scale
Measured: Within 30 sec after procedure started
Secondary outcomes (1)
GSR
Galvanic skin response
Measured: Within 30 sec after procedure started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start25 Apr 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala County Council, Sweden
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902859
- Sponsor's protocol ID
- 273547
- Acronym
- cloROP
- Status last verified
- Apr 2022
- First submitted
- 21 May 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carlsen Misic M, Eriksson M, Normann E, Pettersson M, Blomqvist Y, Olsson E. Clonidine as analgesia during retinopathy of prematurity screening in preterm infants (cloROP): protocol for a randomised controlled trial. BMJ Open. 2022 Sep 22;12(9):e064251. doi: 10.1136/bmjopen-2022-064251.
PubMed 36137627
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonidine as Pain Relief During ROP Eye Examinations
- ClinicalTrials.gov ID
- NCT04902859
- Acronym / sponsor ID
- cloROP / 273547
- Keywords
- retinopathy of prematurity, procedural pain, neonatal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Uppsala County Council, Sweden
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. These eye examinations are painful and despite a lot of research no clear method of pain relief have been found. Since pain in the preterm infant can lead to both short- and longterm negative consequences an effective pain relief during these examinations are of importance. In this study we will investigate if Clonidine can be effective as pain-relief during ROP eye examinations.
Detailed description
Infants born before gestational week (GA) 30 who are cared for in neonatal units at the university hospitals in Örebro and Uppsala, Sweden can be included in the study.
According to power calculations 18 infants are needed for a power of 80% and significance level of 0.05 in order to cover for potential dropouts we plan to include 25 infants. Since the eye examinations are performed without eye speculum in Örebro and with eye speculum in Uppsala we plan to include 25 infants at each unit. The patient will be its own control and examined according to the units´ guidelines. Data will be collected during the patients´ first two eye examinations. In order to exclude potential effects of previous pain experience the order of treatment (clonidine/sterile water) will be randomized.
Sixty minutes before the first eye examination the infant will receive Clonidine or sterile water in corresponding volumes in the GI-tube by a nurse. During the examination the infant will be placed on a heated examination table and connected to an oxygen saturation probe (measuring oxygen saturation and heart rate) on one foot and electrodes for Galvanic skin response (GSR) on the other. The ophthalmologist will examine the infants eyes without eye speculum or with eye speculum on the respective unit. The infants face, oxygen saturation and heart rate will be videotaped before, during and after the examination making it possible to perform av PIPP-R pain assessment at a later time.
After the eye examination the ophtalmologist will be asked to estimate hos easy the infant was to examine by putting an "x" somewhere on a 10 centimeter long line where one end signifies "very easy to examine" and the other end signifies "very difficult to examine". The ophtalmologist can also write any other comments regarding the examination on the same form. The same procedure will be repeated during the infants´ second examination, but with the treatment he/she did not receive during the first examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clonidine with eye speculum | Experimental | Drug: Clonidine Oral Liquid Product4 mcg/kg Clonidine given orally in GI-tube. |
| Placebo with eye speculum | Placebo comparator | Drug: Sterile waterSterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube. |
| Clonidine without eye speculum | Experimental | Drug: Clonidine Oral Liquid Product4 mcg/kg Clonidine given orally in GI-tube. |
| Placebo without eye speculum | Placebo comparator | Drug: Sterile waterSterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube. |
Who may qualify
- Ages
- 5 weeks to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born before 30 weeks gestation, informed consent from parents
Key exclusion criteria (1 listed)
- Infants that have received other pain relieving or sedating drugs within 24 hours before the procedure, infants without GI-tube, infants with neurological deficit, infants with known heart arrhythmia, infants with circulatory instability (MAP below GA in weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidine Oral Liquid ProductClonidine prepared from pharmacy with 20 mcg/ml concentration. | Drug | Clonidine with eye speculum, Clonidine without eye speculum |
| Sterile waterSterile water used as placebo | Drug | Placebo with eye speculum, Placebo without eye speculum |
Primary outcome
PIPP-R
Time frame: Within 30 sec after procedure started
Pain assessment scale
1 secondary outcome
GSR
Time frame: Within 30 sec after procedure started
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 36137627Carlsen Misic M, Eriksson M, Normann E, Pettersson M, Blomqvist Y, Olsson E. Clonidine as analgesia during retinopathy of prematurity screening in preterm infants (cloROP): protocol for a randomised controlled trial. BMJ Open. 2022 Sep 22;12(9):e064251. doi: 10.1136/bmjopen-2022-064251.
- Individual participant dataSharing planned: No
Related trials for Retinopathy of Prematurity
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clonidine Oral Liquid Product and Sterile water in people with Retinopathy of Prematurity and Pain, Procedural, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Pettersson, MD, PhD (+46196023491, miriam.pettersson@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PIPP-R (time frame: Within 30 sec after procedure started). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04902859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.