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Multi-Center Study to Determine the Role of Fatty Acids in Serum in Preventing Retinopathy of Prematurity (MDM)

NCT03201588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2019-12-18

No results posted yet for this study

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.

Conditions

  • Ophthalmological Disorder

Interventions

DIETARY_SUPPLEMENT

Formulaid

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

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Göteborg University

    lead OTHER

Principal Investigators

  • Ann ca Hellstrom, Professor · Göteborg University

  • David Ley, Professor · University of Lund

  • Boubou Hallberg, MD,PhD · University of Karolinska

  • Karin Savman, MD, PhD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Weeks
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2019-11-15
Completion
2019-12-13

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03201588 on ClinicalTrials.gov