Brief Title
A Fatty Acids Study in Preventing Retinopathy of Prematurity
Official Title
A Randomised Intervention Single Center Study to Determine the Role of Fatty Acids in Serum in Preventing Retinopathy of Prematurity
Brief Summary
Most fatty acids, important for development and especially the Omega-3 fatty acids for the
brain development are transferred in the third trimester with means that in the premature
infant this transport via the placenta is interrupted and the infant is dependent on the
concentrations in breast milk which vary depending on the mother's diet and her stores. It
has even been suggested that low Omega-3 would be a cause of premature delivery. Many
countries have much higher levels of Omega-3 fatty acids in breast milk than found in Sweden
and breast milk substitutions are generally now supplemented with the Long Chained Poly
Unsaturated Fatty Acids (LCPUFA). Therefore the supplementation to be given can not be seen
to give any risks for the infant. On the contrary, several studies have shown that mother who
eat equal to or less than twice fish a week during pregnancy give birth to infants with
impaired development.
Low Omega-3 levels in premature infants between gestational ages of 23 and 40 weeks can be
one reason for Retinopathy of Prematurity (ROP) development. Restoration of Omega-3,
Dokosahexaenacid (DHA) and Eikosapentaenacid (EPA) to normal in utero levels may prevent ROP
by allowing normal vessel growth and survival. An increase of Omega-3 levels bringing levels
to within physiological range may prevent development of ROP.
Detailed Description
The study is a Randomised Intervention, Single-Center Study to Determine the Role of Fatty
Acids in Serum and Breast Milk in preventing Retinopathy of Prematurity.
Subjects who meet all inclusion and none of the exclusion criteria will be enrolled into the
study. Upon entry into the study, subjects will be randomized and given a unique subject
number.
A randomised intervention study of 45+45 infants without major malformations born with a
gestational age less than 28 weeks + 0 days will be performed.
Randomization of the patients to either:
1. Conventional fatty acid supplementation regime with Clinoleic (with Vitalipid infant and
Soluvit supplementation) to the preterm infant
Or
2. SMOFlipid, (soybean oil, medium chain triglycerides, olive oil and fish oil),(with
Vitalipid infant and Soluvit supplementation), where the quotient of Omega 6:3 is 2.5:1
in order to mimic the physiologic relation of fatty acids in cord blood from birth, to
the preterm infant.
Thus there is one group of infants (n=45) that will receive Omega-3 in the fatty acid
supplementation.
The time on parenteral nutrition and the amount of fatty acids given will be according to
clinical routines.
The randomization of the patients will be performed by the controller of the study.
Randomization will be in blocks with 10 children in each block.
Data collection
After the investigators have received informed consent from the parents/guardians, blood
samples 0.2 ml from the child will be taken according to present clinical practice at if
possible from cord (2ml) and at days 0, 7, 14, 28 and in postmenstrual weeks 32, 36 and 40.
Blood samples from the mothers for Fatty Acids analyses will be taken after birth, day 7 and
at gestational weeks 36 and 40. At the same time (except from day 1), breast milk samples are
taken. Length in cm, weight in gram and head circumference in cm are measured weekly.
Screening for ROP will be performed, at least once a week, according to clinical routines
using a specific protocol.
The investigators intend to analyze the content of phospholipids which can be done on small
amounts of blood, is relatively insensitive to short term fluctuations in intake and mirror
the composition of many membranes in the body. The analyses will be made using gas-liquid
chromatography. The method has a coefficient of variability of 1-3% for the Fatty Acids
concerned.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Retinopathy of Prematurity
Secondary Outcome
Brain Growth
Condition
Retinopathy of Prematurity
Intervention
SMOFlipid
Study Arms / Comparison Groups
Clinoleic
Description: Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
90
Start Date
March 2013
Completion Date
September 2015
Primary Completion Date
September 2015
Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent from parents/guardians;
2. Subject must be below 28 weeks of gestation
Exclusion Criteria:
1. Detectable clinical gross malformation;
2. Known or suspected chromosomal abnormality, genetic disorder, or syn-drome, according
to the investigator's opinion;
3. Clinically significant neuropathy, nephropathy, retinopathy, or other micro- or
macrovascular disease requiring treatment, according to the investigator's opinion;
4. Any other condition or therapy that, in the investigator's opinion, may pose a risk to
the subject or interfere with the subject's ability to be compliant with this protocol
or interfere with interpretation of results.
5. Bleeding disorder.
Gender
All
Ages
23 Weeks - 28 Weeks
Accepts Healthy Volunteers
No
Contacts
Carola Pfeiffer-Mosesson, RN, ,
Administrative Informations
NCT ID
NCT02760472
Organization ID
2008-000046-31
Responsible Party
Sponsor-Investigator
Study Sponsor
Carola Pfeiffer-Mosesson
Study Sponsor
Carola Pfeiffer-Mosesson, RN, Principal Investigator, The Queen Silvia Children's Hospital
Verification Date
April 2016