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Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates

NCT01745510 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2021-03-24

No results posted yet for this study

Summary

* The purpose of this study is to determine whether docosahexaenoic acid is effective in the prevention or reducing severity of necrotizing enterocolitis (NEC) in preterm neonates \< 1500 g at birth who are starting enteral feeding.
* if NEC is prevented, this study will measure whether hospital stay is also reduced in neonates who receive Docosahexaenoic acid (DHA)

Conditions

  • Necrotizing Enterocolitis

Interventions

DIETARY_SUPPLEMENT

Docosahexaenoic acid (DHA)

Docosahexaenoic acid from algae source

DIETARY_SUPPLEMENT

Placebo

Placebo was designed to mimic the color and consistence of the oil that contains DHA

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Mariela Bernabe-Garcia, PhD · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Minutes
Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • Mexico

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 NCT01745510 on ClinicalTrials.gov