DonnaMega: A Fatty Acids Study in Preventing Retinopathy of Prematurity

Sponsor

Carola Pfeiffer-Mosesson (Other)

Overall Status

Completed

CT.gov ID

NCT02760472

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinopathy of Prematurity	Drug: SMOFlipid Drug: Clinoleic	Phase 3

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:

Conventional fatty acid supplementation regime with Clinoleic (with Vitalipid infant and Soluvit supplementation) to the preterm infant

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Randomised Intervention Single Center Study to Determine the Role of Fatty Acids in Serum in Preventing Retinopathy of Prematurity

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clinoleic Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity	Drug: Clinoleic Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity
Experimental: SMOFlipid Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity	Drug: SMOFlipid Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity

Arm

Intervention/Treatment

Active Comparator: Clinoleic

Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity

Drug: Clinoleic

Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity

Experimental: SMOFlipid

Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity

Drug: SMOFlipid

Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity

Outcome Measures

Primary Outcome Measures

Retinopathy of Prematurity [When the retina is fully vascularised,i.e. at approximately 40 postmenstrual weeks.]
We intend to analyze the content of Fatty Acids and correlate to Retinopathy of Prematurity development and interventional treatment. Analyze of phospholipids 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.

Secondary Outcome Measures

Brain Growth [At 40 postmenstrual weeks and at 2.5 and 6 years.]
Cranial ultrasound will be performed according to clinical praxis. MRI of the brain will be performed at 40 weeks postmenstrual age (PMA) and correlated to interventional treatment.
Length in cm [At 40 postmenstrual weeks and at 2.5 and 6 years.]
Length in cm given in absolute values and in standard deviation scores, at 40 weeks postmenstrual age (PMA) and at 2.5 and 6 years will be correlated to interventional treatment.
Weight in gram [At 40 postmenstrual weeks and at 2.5 and 6 years.]
Weight in gram given in absolute values and in standard deviation scores, at 40 weeks postmenstrual age (PMA) and at 2.5 and 6 years will be correlated to interventional treatment.
Head circumference in cm [At 40 postmenstrual weeks and at 2.5 and 6 years.]
Head circumference in cm given in absolute values and in standard deviation scores, at 40 weeks postmenstrual age (PMA) and at 2.5 and 6 years will be correlated to interventional treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Weeks to 28 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent from parents/guardians;
Subject must be below 28 weeks of gestation

Exclusion Criteria:

Detectable clinical gross malformation;
Known or suspected chromosomal abnormality, genetic disorder, or syn-drome, according to the investigator's opinion;
Clinically significant neuropathy, nephropathy, retinopathy, or other micro- or macrovascular disease requiring treatment, according to the investigator's opinion;
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.
Bleeding disorder.