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The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities

NCT01875510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-07-08

Study results available
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Summary

Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal development. Infants born prematurely are at special risk for DHA insufficiency. The source of DHA after birth for preterm babies who are not fed full enterally, are mostly fat emulsions as the component of total parenteral nutrition solutions which usually do not contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered from the first day of life and during parenteral nutrition-prevents infants from cholestasis and retinopathy of prematurity.

Conditions

  • Retinopathy of Prematurity
  • Neonatal Cholestasis

Interventions

DIETARY_SUPPLEMENT

Fish-oil emulsions

Fish -oil emulsions: Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.

DIETARY_SUPPLEMENT

soybean-oil emulsion

soybean-oil emulsion

Sponsors & Collaborators

  • Dr. Sami Ulus Children's Hospital

    lead OTHER

Principal Investigators

  • Serdar Beken · Dr. Sami Ulus Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-09-30
Completion
2013-11-30

Countries

  • Turkey (Türkiye)

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 NCT01875510 on ClinicalTrials.gov