Evaluation of the Retinopathy of Prematurity Activity Scale (ROP-ActS) in a randomised controlled trial aiming for prevention of severe ROP: a substudy of the Mega Donna Mega trial.
Diagnostic tests/Investigation
Retina
Treatment other
Vision
Journal
BMJ open ophthalmology
ISSN: 2397-3269
Titre abrégé: BMJ Open Ophthalmol
Pays: England
ID NLM: 101714806
Informations de publication
Date de publication:
2022
2022
Historique:
received:
14
10
2021
accepted:
28
03
2022
entrez:
2
5
2022
pubmed:
3
5
2022
medline:
4
5
2022
Statut:
epublish
Résumé
The current grading of retinopathy of prematurity (ROP) does not sufficiently discriminate disease severity for evaluation of trial interventions. The published ROP Activity Scales (original: ROP-ActS and modified: mROP-ActS), describing increasing severity of ROP, versus the categorical variables severe ROP, stage, zone and plus disease were evaluated as discriminators of the effect of an ROP preventive treatment. The Mega Donna Mega trial investigated ROP in infants born <28-week gestational age (GA), randomised to arachidonic acid (AA) and docosahexaenoic acid (DHA) supplementation or no supplementation. Of 207 infants, 86% with finalised ROP screening were included in this substudy. ROP-ActS versus standard variables were evaluated using Fisher's non-parametric permutation test, multivariable logistic and linear regression and marginal fractional response models. The AA:DHA group (n=84) and the control group (n=93) were well balanced. The maximum ROP-ActS measurement was numerically but not significantly lower in the AA:DHA group (mean: 4.0 (95% CI 2.9 to 5.0)) versus the control group (mean: 5.3 (95% CI 4.1 to 6.4)), p=0.11. In infants with any ROP, the corresponding scale measurements were 6.8 (95% CI 5.4 to 8.2) and 8.7 (95% CI 7.5 to 10.0), p=0.039. Longitudinal profiles of the scale were visually distinguished for the categories of sex and GA for the intervention versus control. The preventive effect of AA:DHA supplementation versus no supplementation was better discriminated by the trial's primary outcome, severe ROP, than by ROP-ActS. The sensitivity and the linear qualities of ROP-ActS require further validations on large data sets and perhaps modifications. NCT03201588.
Identifiants
pubmed: 35495419
doi: 10.1136/bmjophth-2021-000923
pii: bmjophth-2021-000923
pmc: PMC8996016
doi:
Substances chimiques
Docosahexaenoic Acids
25167-62-8
Arachidonic Acid
27YG812J1I
Banques de données
ClinicalTrials.gov
['NCT03201588']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e000923Subventions
Organisme : NICHD NIH HHS
ID : P50 HD105351
Pays : United States
Organisme : NEI NIH HHS
ID : R01 EY030904
Pays : United States
Organisme : NEI NIH HHS
ID : R01 EY017017
Pays : United States
Organisme : NICHD NIH HHS
ID : U54 HD090255
Pays : United States
Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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