CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 210 enrolled
Drug / intervention
Formulaiddietary
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03201588
NCT03201588N/ACompleted
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A Randomized Intervention, Multi-Center Study to Determine the Role of Fatty Acids in Serum in Preventing Retinopathy of Prematurity (MDM)

Göteborg University·interventional·Posted Jun 28, 2017·Updated Dec 18, 2019

In Brief

A clinical study evaluating Formulaid for Ophthalmological Disorder. Completed, enrolled 210 participants across 3 sites.

Detailed Summary

The study is a Randomized Intervention, Multi-Center Study to Determine the Role of Fatty Acids in Serum and Breast Milk in preventing Retinopathy of Prematurity Subjects who meet all inclusion and none of the exclusion criteria will be enrolled into the study. Upon entry into the study, subjects will be randomized and given a unique subject number. A randomized intervention study of 105+105 (number based on power analysis regarding up to date ROP frequency, see 5.1 and 11.1) infants without major malformations born with a gestational age less than 28 weeks + 0 days will be performed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOphthalmological Disorder
CountriesSweden
CollaboratorsThe Swedish Research Council

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 28, 2017
Enrollment StartDec 15, 2016
Primary CompletionNov 15, 2019
Study CompletionDec 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.0 years ago

Interventions

Formulaiddietary

Arachidonic acids (AA) Docosahexaenoic Acids(DHA) 2:1