The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Serdar Beken, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier:
NCT01875510
First received: May 31, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Retinopathy of Prematurity
Neonatal Cholestasis
Dietary Supplement: Fish-oil emulsions
Dietary Supplement: soybean-oil emulsion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Fish-oil Lipid Emulsions on Neonatal Cholestasis and Retinopathy of Prematurity

Resource links provided by NLM:


Further study details as provided by Dr. Sami Ulus Children's Hospital:

Primary Outcome Measures:
  • Number of Participants With Retinopathy of Prematurity [ Time Frame: Corrected age 32 weeks or postnatal 28th day ] [ Designated as safety issue: Yes ]
    The number of Participants with Retinopathy of Prematurity will be defined.


Enrollment: 80
Study Start Date: January 2013
Study Completion Date: November 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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: 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.

Other Name: Smoflipid
Dietary Supplement: soybean-oil emulsion
soybean-oil emulsion
Other Name: Intralipid
Placebo Comparator: soybean-oil emulsion
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 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.

Other Name: Smoflipid
Dietary Supplement: soybean-oil emulsion
soybean-oil emulsion
Other Name: Intralipid

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).

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants below 32 gestational age and requiring parenteral nutrition

Exclusion Criteria:

  • Infants with congenital anomalies, infants above 32 gestational age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875510

Locations
Turkey
Dr. Sami Ulus Childrens Hospital
Ankara, Turkey, 06080
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
Principal Investigator: Serdar Beken Dr. Sami Ulus Children's Hospital
  More Information

Publications:
Responsible Party: Serdar Beken, M.D., Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT01875510     History of Changes
Other Study ID Numbers: B.10.4.İSM.4.06.68.49/144
Study First Received: May 31, 2013
Results First Received: November 11, 2013
Last Updated: June 5, 2014
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Cholestasis
Retinal Diseases
Retinopathy of Prematurity
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 14, 2014