The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities

Dr. Sami Ulus Children's Hospital

Status: Completed

Conditions: Retinopathy of Prematurity; Neonatal Cholestasis

Treatments: Dietary Supplement: Fish-oil emulsions; Dietary Supplement: soybean-oil emulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT01875510

B.10.4.İSM.4.06.68.49/144

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 patients

Sex: All

Ages: 1 to 3 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants below 32 gestational age and requiring parenteral nutrition

Exclusion criteria

• Infants with congenital anomalies, infants above 32 gestational age

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Fish-oil emulsions

Active Comparator group

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.

Treatment:

Dietary Supplement: soybean-oil emulsion

Dietary Supplement: Fish-oil emulsions

soybean-oil emulsion

Placebo Comparator group

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

Treatment:

Dietary Supplement: soybean-oil emulsion

Dietary Supplement: Fish-oil emulsions