To Assess the Effect of Dexamethasone Eye Drops on the Retinopathy of Prematurity Outcome

NCT06775353 | Completed

• 1 other identifier: 2022-05824-01
• Study Type: observational
• Target: 2,017
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to compare the treatment frequency of preterm infants who developed severe Retinopathy of Prematurity (ROP) during the years 2015-2018 with 2020-2021 in the country, using the statistical method 'difference in differences' to investigate the potential for scientific evidence regarding the introduction of dexamethasone eye drops' effect on the development of severe treatment-requiring ROP. During these years, the investigatots assess that the recommended oxygen saturation levels for preterm infants have remained stable at each clinic, which will serve as its own reference.

Conditions

Retinopathy of Prematurity (ROP)

Keywords

topical dexamethasone

Outcome Measures

Primary Outcomes (1)

• Show the clinical effect of dexamethasone eyedrops in reducing treatment-requiring severe ROP

  Has the treatment frequency of severe ROP decreased in the Southern healthcare region compared to other healthcare regions after the introduction of early low-dose corticosteroid treatment in the form of eye drops? Treatment frequency will also be analyzed for all children screened during these years. The statistical method difference in differences will be used in the analyses. Age at treatment will also be studied to see if the cortisone drops affect this factor.

  The treatment frequency was compared for the intervention group with the control group during the control years 2015-2018 and the intervention years 2020-2021 when dexamethasone eye drops were introduced in the intervention group.

Study Arms (1)

all screened infants for ROP borne before week 30 in four swedish regions

The treatment frequency for severe ROP was compared between the control years 2015-2018 and the intervention years 2020-2021, but also for all children screened during these years. One region introduced dexamethasone eye drops during the intervention years. The other three regions did not and thus served as a control group.

Drug: Dexamethasone eyedrop

Interventions

Dexamethasone eyedrop DRUG

Infants who developed stages of pretreatment-requiring severe ROP were usually given one eyedrop of dexamethasone daily until the ROP changes regressed.

all screened infants for ROP borne before week 30 in four swedish regions

Eligibility Criteria

• Age: 31 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between 2015-2018 and 2020-2021, all children born before week 30 in the Southern Healthcare Region and three other regions where dexamethasone eye drops were not used to prevent severe treatment-requiring ROP were included in the study population. A specific analysis was conducted on the children who developed severe ROP, Type 1 and Type 2 ROP.

You may qualify if:

• \- During 2015-2018 and 2020-2021, all children born before week 30 in the Southern Health Region and three regions where dexamethasone eye drops were not used to prevent severe treatment-requiring ROP were included

You may not qualify if:

• If a child has not completed the screening examinations for ROP-

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Clinical Sciences, Ophthalmology, Lund University, Skåne University Hospital, Lund, Sweden

Lund, Skåne County, 22185, Sweden

Location

Related Publications (5)

• Rivera JC, Holm M, Austeng D, Morken TS, Zhou TE, Beaudry-Richard A, Sierra EM, Dammann O, Chemtob S. Retinopathy of prematurity: inflammation, choroidal degeneration, and novel promising therapeutic strategies. J Neuroinflammation. 2017 Aug 22;14(1):165. doi: 10.1186/s12974-017-0943-1.

  PMID: 28830469 BACKGROUND

• Doyle LW, Cheong JL, Ehrenkranz RA, Halliday HL. Early (< 8 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database Syst Rev. 2017 Oct 24;10(10):CD001146. doi: 10.1002/14651858.CD001146.pub5.

  PMID: 29063585 BACKGROUND

• Chiang MF, Quinn GE, Fielder AR, Ostmo SR, Paul Chan RV, Berrocal A, Binenbaum G, Blair M, Peter Campbell J, Capone A Jr, Chen Y, Dai S, Ells A, Fleck BW, Good WV, Elizabeth Hartnett M, Holmstrom G, Kusaka S, Kychenthal A, Lepore D, Lorenz B, Martinez-Castellanos MA, Ozdek S, Ademola-Popoola D, Reynolds JD, Shah PK, Shapiro M, Stahl A, Toth C, Vinekar A, Visser L, Wallace DK, Wu WC, Zhao P, Zin A. International Classification of Retinopathy of Prematurity, Third Edition. Ophthalmology. 2021 Oct;128(10):e51-e68. doi: 10.1016/j.ophtha.2021.05.031. Epub 2021 Jul 8.

  PMID: 34247850 BACKGROUND

• Holmstrom G, Hellstrom A, Granse L, Saric M, Sunnqvist B, Wallin A, Tornqvist K, Larsson E. New modifications of Swedish ROP guidelines based on 10-year data from the SWEDROP register. Br J Ophthalmol. 2020 Jul;104(7):943-949. doi: 10.1136/bjophthalmol-2019-314874. Epub 2019 Nov 1.

  PMID: 31676594 BACKGROUND

• Ohnell HM, Andreasson S, Granse L. Dexamethasone Eye Drops for the Treatment of Retinopathy of Prematurity. Ophthalmol Retina. 2022 Feb;6(2):181-182. doi: 10.1016/j.oret.2021.09.002. Epub 2021 Sep 10. No abstract available.

  PMID: 34517147 BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: December 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)