NCT01875510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

May 31, 2013

Results QC Date

November 11, 2013

Last Update Submit

June 5, 2014

Conditions

Retinopathy of PrematurityNeonatal Cholestasis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Retinopathy of Prematurity

    The number of Participants with Retinopathy of Prematurity will be defined.

    Corrected age 32 weeks or postnatal 28th day

Study Arms (2)

Fish-oil emulsions

ACTIVE COMPARATOR

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: Fish-oil emulsionsDietary Supplement: soybean-oil emulsion

soybean-oil emulsion

PLACEBO COMPARATOR

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

Dietary Supplement: Fish-oil emulsionsDietary Supplement: soybean-oil emulsion

Interventions

Fish-oil emulsionsDIETARY_SUPPLEMENT

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.

Also known as: Smoflipid
Fish-oil emulsionssoybean-oil emulsion
soybean-oil emulsionDIETARY_SUPPLEMENT

soybean-oil emulsion

Also known as: Intralipid
Fish-oil emulsionssoybean-oil emulsion

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants below 32 gestational age and requiring parenteral nutrition

You may not qualify if:

  • Infants with congenital anomalies, infants above 32 gestational age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Sami Ulus Childrens Hospital

Ankara, 06080, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 21199856RESULT

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

SMOFlipidSoybean Oilsoybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Limitations and Caveats

The limitation of our study is that participants are mostly above 1000 grams. It was a single center study and DHA levels were not measured.

Results Point of Contact

Title
Dr. Serdar Beken
Organization
Dr. Sami Ulus Children's Hospital
serbeken@gmail.com
00903123056449

Study Officials

  • Serdar Beken

    Dr. Sami Ulus Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 31, 2013

First Posted

June 11, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2013

Study Completion

November 1, 2013

Last Updated

July 8, 2014

Results First Posted

July 8, 2014

Record last verified: 2014-06

Locations

TU(1)