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NCT Number: NCT01875510

The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Neonatal Cholestasis Retinal Diseases

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sami Ulus Childrens Hospital

Ankara, 06080, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants below 32 gestational age and requiring parenteral nutrition

Exclusion criteria

  • Infants with congenital anomalies, infants above 32 gestational age

Treatment and study plan

Fish-oil emulsions

Dietary 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.

Other names: Smoflipid

soybean-oil emulsion

Dietary Supplement

soybean-oil emulsion

Other names: Intralipid

Primary outcomes

  1. Number of Participants With Retinopathy of Prematurity

    Time frame: Corrected age 32 weeks or postnatal 28th day

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

Sponsors and collaborators

Lead sponsor

Dr. Sami Ulus Children's Hospital

Other

Registry information

Official study title

The Effect of Fish-oil Lipid Emulsions on Neonatal Cholestasis and Retinopathy of Prematurity

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2013
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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