Retinopathy of PrematurityNCT01875510
The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities
A study testing Fish-oil emulsions and soybean-oil emulsion in people with Retinopathy of Prematurity and Neonatal Cholestasis, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Retinopathy of Prematurity, Neonatal Cholestasis
- What is being tested?
- Fish-oil emulsions and soybean-oil emulsion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants below 32 gestational age and requiring parenteral nutrition
Who cannot join
- Infants with congenital anomalies, infants above 32 gestational age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Sami Ulus Childrens Hospital
Ankara, 06080
About this study
Official title: The Effect of Fish-oil Lipid Emulsions on Neonatal Cholestasis and Retinopathy of Prematurity
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.
Read the 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).
- Conditions
- Retinopathy of Prematurity, Neonatal Cholestasis
- Being tested
- Fish-oil emulsions, soybean-oil emulsion
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish-oil emulsionsDietary supplement
Also called Smoflipid
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.
soybean-oil emulsionDietary supplement
Also called Intralipid
soybean-oil emulsion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Fish-oil emulsions; Dietary 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 Receives: Dietary Supplement: Fish-oil emulsions; Dietary Supplement: soybean-oil emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Retinopathy of Prematurity
The number of Participants with Retinopathy of Prematurity will be defined.
Measured: Corrected age 32 weeks or postnatal 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Beken, Dr. Sami Ulus Children's Hospital
- Investigators
- Serdar Beken, Principal investigator, Dr. Sami Ulus Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875510
- Sponsor's protocol ID
- B.10.4.İSM.4.06.68.49/144
- Status last verified
- Jun 2014
- First submitted
- 31 May 2013
- Last updated
- 8 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21199856
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fish-oil Lipid Emulsions on Neonatal Cholestasis and Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT01875510
- Acronym / sponsor ID
- B.10.4.İSM.4.06.68.49/144
- Conditions
- Retinopathy of Prematurity, Neonatal Cholestasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Posted 8 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish-oil emulsions | Active comparator | Dietary Supplement: Fish-oil emulsions, Dietary Supplement: soybean-oil emulsionFish-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. |
| soybean-oil emulsion | Placebo comparator | Dietary Supplement: Fish-oil emulsions, Dietary Supplement: soybean-oil emulsionPreterm 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 |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants below 32 gestational age and requiring parenteral nutrition
Key exclusion criteria (1 listed)
- Infants with congenital anomalies, infants above 32 gestational age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish-oil emulsionsAlso: SmoflipidFish -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, soybean-oil emulsion |
| soybean-oil emulsionAlso: Intralipidsoybean-oil emulsion | Dietary supplement | Fish-oil emulsions, soybean-oil emulsion |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21199856Pawlik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serdar Beken principal investigator
Dr. Sami Ulus Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish-oil emulsions and soybean-oil emulsion in people with Retinopathy of Prematurity and Neonatal Cholestasis, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Retinopathy of Prematurity (time frame: Corrected age 32 weeks or postnatal 28th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01875510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.