The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities

This study is currently recruiting participants.
Verified June 2013 by Dr. Sami Ulus Children's Hospital
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 7, 2013
Last verified: June 2013
  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: Single Group 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:
  • Stage of retinopathy of prematurity (I-V) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 emulsions
none
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: soybean-oil emulsion

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

Contacts
Contact: Serdar Beken

Locations
Turkey
Dr. Sami Ulus Childrens Hospital Recruiting
Ankara, Turkey, 06080
Contact: Serdar Beken, M.D    00903123056449    serbeken@gmail.com   
Principal Investigator: Serdar Beken, M.D         
Sponsors and Collaborators
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
Last Updated: June 7, 2013
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 April 17, 2014