Back to resultsThe Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities
Primary Purpose
Retinopathy of Prematurity, Neonatal Cholestasis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fish-oil emulsions
soybean-oil emulsion
Sponsored by
About this trial
This is an interventional prevention trial for Retinopathy of Prematurity
Eligibility Criteria
Inclusion Criteria:
- Infants below 32 gestational age and requiring parenteral nutrition
Exclusion Criteria:
- Infants with congenital anomalies, infants above 32 gestational age
Sites / Locations
- Dr. Sami Ulus Childrens Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Fish-oil emulsions
soybean-oil emulsion
Arm Description
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.
Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
Outcomes
Primary Outcome Measures
Number of Participants With Retinopathy of Prematurity
The number of Participants with Retinopathy of Prematurity will be defined.
Secondary Outcome Measures
Full Information
NCT ID
NCT01875510
First Posted
May 31, 2013
Last Updated
June 5, 2014
Sponsor
Dr. Sami Ulus Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01875510
Brief Title
The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities
Official Title
The Effect of Fish-oil Lipid Emulsions on Neonatal Cholestasis and Retinopathy of Prematurity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Sami Ulus Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
During the study period, preterm infants admitted to NICU were included. Infants who weighed <1500 gr and delivered prematurely before the 32nd week of gestation were eligible for the study. Infants with major congenital anomalies, congenital infections and inborn metabolic errors were excluded from the study.
Group 1: Fish-oil emulsion (20% SMOFLipid: soybean oil 60 g/dL, MCT 60 g/dL, olive oil 50 g/dL, fish oil 30 g/dL, egg phospholipids 12 g/dL, glycerol 25 g/dL, vitamin E 200 mg α-TE/L) Group 2: Soybean oil emulsion (20% Intralipid: soybean oil 200 g/dL, egg phospholipids 12 g/dL, glycerol 22,5 g/dL, vitamin E 57 mg α-TE/L).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity, Neonatal Cholestasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish-oil emulsions
Arm Type
Active Comparator
Arm Description
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.
Arm Title
soybean-oil emulsion
Arm Type
Placebo Comparator
Arm Description
Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish-oil emulsions
Other Intervention Name(s)
Smoflipid
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
soybean-oil emulsion
Other Intervention Name(s)
Intralipid
Intervention Description
soybean-oil emulsion
Primary Outcome Measure Information:
Title
Number of Participants With Retinopathy of Prematurity
Description
The number of Participants with Retinopathy of Prematurity will be defined.
Time Frame
Corrected age 32 weeks or postnatal 28th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants below 32 gestational age and requiring parenteral nutrition
Exclusion Criteria:
Infants with congenital anomalies, infants above 32 gestational age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar Beken
Organizational Affiliation
Dr. Sami Ulus Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Sami Ulus Childrens Hospital
City
Ankara
ZIP/Postal Code
06080
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
21199856
Citation
Pawlik D, Lauterbach R, Turyk E. Fish-oil fat emulsion supplementation may reduce the risk of severe retinopathy in VLBW infants. Pediatrics. 2011 Feb;127(2):223-8. doi: 10.1542/peds.2010-2427. Epub 2011 Jan 3.
Results Reference
result
Learn more about this trial
The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities
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