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Clonidine as Pain Relief During ROP Eye Examinations (cloROP)

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ClinicalTrials.gov Identifier: NCT04902859
Recruitment Status : Recruiting
First Posted : May 26, 2021
Last Update Posted : May 4, 2022
Sponsor:
Collaborator:
Uppsala County Council, Sweden
Information provided by (Responsible Party):
Region Örebro County

Tracking Information
First Submitted Date  ICMJE May 21, 2021
First Posted Date  ICMJE May 26, 2021
Last Update Posted Date May 4, 2022
Actual Study Start Date  ICMJE April 25, 2022
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2021)		 PIPP-R [ Time Frame: Within 30 sec after procedure started ]
Pain assessment scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2021)		 GSR [ Time Frame: Within 30 sec after procedure started ]
Galvanic skin response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clonidine as Pain Relief During ROP Eye Examinations
Official Title  ICMJE Clonidine as Pain Relief During ROP Eye Examinations
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
None of the above will be aware of study drug or placebo.
Primary Purpose: Treatment
Condition  ICMJE
  • Retinopathy of Prematurity
  • Pain, Procedural
  • Premature Infant Disease
Intervention  ICMJE
  • Drug: Clonidine Oral Liquid Product
    Clonidine prepared from pharmacy with 20 mcg/ml concentration.
  • Drug: Sterile water
    Sterile water used as placebo
Study Arms  ICMJE
  • Experimental: Clonidine with eye speculum
    4 mcg/kg Clonidine given orally in GI-tube.
    Intervention: Drug: Clonidine Oral Liquid Product
  • Placebo Comparator: Placebo with eye speculum
    Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.
    Intervention: Drug: Sterile water
  • Experimental: Clonidine without eye speculum
    4 mcg/kg Clonidine given orally in GI-tube.
    Intervention: Drug: Clonidine Oral Liquid Product
  • Placebo Comparator: Placebo without eye speculum
    Sterile water corresponding to the same volume as 4 mcg/kg of Clonidine given orally in GI-tube.
    Intervention: Drug: Sterile water
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2021)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants born before 30 weeks gestation, informed consent from parents

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Weeks to 3 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Miriam Pettersson, MD, PhD +46196023491 miriam.pettersson@regionorebrolan.se
Contact: Emma Olsson, RN, PhD +4619303616 emma.olsson@oru.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04902859
Other Study ID Numbers  ICMJE 273547
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Region Örebro County
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Region Örebro County
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Uppsala County Council, Sweden
Investigators  ICMJE Not Provided
PRS Account Region Örebro County
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP