Premature male/female infants, <28 gestational weeks at birth with risk of developing retinopathy of prematurity (ROP)
Conditions
Interventions
Trade Name: SMOFlipid 200 mg/ml
Product Name: SMOFlipid 200 mg/ml
Pharmaceutical Form: Emulsion for infusion
Trade Name: Clinoleic 200mg/ml/B05BA02/Emulsion for Infusion
Product Name: Clinoleic 200mg
Sponsors
The Sahlgrenska Center for Pediatric Ophtalmology Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all the following inclusion criteria to be permitted into this study: 1. Signed informed consent from parents/guardians; 2. Subject must be =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will be excluded from the study: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objective 1) To determine whether these FA levels normalize growth (length, weight, head circumference) and/or 2) To determine whether these FA levels reduce the risk of lung, brain and gut morbidity ;Main Objective: 1) To determine how fatty acid (FA) levels in premature infants (born with a gestational age < 28 weeks) are affected by supplementation of “physiologic levels of long chain polyunsaturated fatty acids (LCPUFA) i.e. Omega-3 and 6. 2) To determine whether these FA levels protect against development of retinopathy of prematurity (ROP). ;Primary end point(s): Efficacy Endpoints: To compare in supplemented versus conventionally treated children A) Bloodsamples from the child will be taken according to present clinical practice and if possible from cord (2ml) and at days 0, 7, 14, 28 and in postmenstrual weeks 32, 36 and 40. Breast milk samples will be taken day 7 and at PMA of 32 and 40 weeks. B) Development of ROP Safety Endpoints: Adverse events, clinical chemistry, retinal exam, physical ex-amination, vital signs. ;Timepoint(s) of evaluation of this end point: ROP examination Retinal examination will be performed once weekly starting at five to six weeks of age according to a standardized protocol and to clinical screening praxis. The ophthalmologic assessment will be performed with strict criteria according to general Swedish Guidelines issued by the Swedish Ophthalmological Society: The Guidelines are available at following link: www.swedeye.org/SOTA/rop/SOTA-ROP_2006.pdf. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A) SDS score with regard to length, weight and head circumference growth B) Bronchopulmonary dysplasia, brain development on MRI examination and necrotizing enterocolitis ;Timepoint(s) of evaluation of this end point: Growth Length, weight and head circumference will be registered weekly from birth until 40 weeks postmenstrual age and at 2.5 and 6 years. Neurologic development Cranial ultrasound will be performed according to clinical praxis. MRI of the brain will be performed at 40 weeks PMA. At 2.5 years a clinical examination including neurologic evaluation (neurologist) cognitive evaluation with Bailey-test (psychologist) and ophthalmologic examination will be performed. At 6 years a clinical examination including neurologic evaluation (neurologist) cognitive evaluation with WPPSI alt WISC, short visuo-motor test and a behavioral test and extensive ophthalmologic examination, including visual perception and morpho-logic and functional examination of the retina, will be performed. | — |
Countries
Sweden
Contacts
Public Contactwww.rop.gu.se/clinical trials
Department of Pediatrics Institute of Clinical Science
Outcome results
None listed