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Effect of Enteral Lipid Supplement on Severe Retinopathy of Prematurity: A Randomized Clinical Trial.

Plain-language guide to PMID 33523106 (2021): double-blind randomized controlled trial of Copper (Supplement) in 209 infants.

Key Facts

PMID
33523106
Journal
JAMA pediatrics
Year
2021
Study type
Randomized Controlled Trial
Authors
Hellström A et al. (20 authors)
DOI
10.1001/jamapediatrics.2020.5653
Registered trial
NCT03201588

What This Study Did, in Plain Language

What Was Tested

Researchers studied Copper (Supplement) in this randomized controlled trial publication.

Lack of arachidonic acid (AA) and docosahexaenoic acid (DHA) after extremely preterm birth may contribute to preterm morbidity, including retinopathy of prematurity (ROP).

Who Took Part

The abstract describes 209 infants taking part.

PubMed tags the participants as both men and women.

The screening pediatric ophthalmologists were masked to patient groupings.

How the Study Was Run

In design terms this was a randomized, double-blind and multicenter study.

Random assignment meant chance, not the researchers, decided who got Copper (Supplement) and who got the comparison, which limits bias.

Neither the infants nor the staff measuring them knew who was on Copper (Supplement), so expectations could not easily colour the readings.

Running at several centres spread the Copper (Supplement) study over different clinics and patient groups.

The Mega Donna Mega trial, a randomized clinical trial, was a multicenter study performed at 3 university hospitals in Sweden from December 15, 2016, to December 15, 2019.

A total of 209 infants born at less than 28 weeks' gestation were tested for eligibility, and 206 infants were included.

Statistical analyses were performed from February to April 2020.

What Was Measured

PubMed files the paper under topics including Arachidonic Acid, Dietary Fats, Dietary Supplements, Docosahexaenoic Acids, Enteral Nutrition, Infant, Premature and Intention to Treat Analysis.

What This Means in Plain Language

The paper is a randomized, double-blind and multicenter study of Copper (Supplement) in 209 infants.

The abstract goes on to report its results in about 9 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2021 (JAMA pediatrics), a journal based in United States.

More context: the Copper (Supplement) compound page, all human trials.

Our Notes on the Compound

Copper (Supplement): The active site of cytochrome c oxidase is described as containing copper ions that are essential for electron transfer.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.