A Fatty Acids Study in Preventing Retinopathy of Prematurity

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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