A Fatty Acids Study in Preventing Retinopathy of Prematurity
Anahtar kelimeler
Öz
Açıklama
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.
Tarih
| Son Doğrulandı: | 03/31/2016 |
| İlk Gönderilen: | 03/29/2016 |
| Tahmini Kayıt Gönderildi: | 04/28/2016 |
| İlk Gönderilen: | 05/02/2016 |
| Son Güncelleme Gönderildi: | 04/28/2016 |
| Son Güncelleme Gönderildi: | 05/02/2016 |
| Fiili Çalışma Başlangıç Tarihi: | 02/28/2013 |
| Tahmini Birincil Tamamlanma Tarihi: | 08/31/2015 |
| Tahmini Çalışma Tamamlanma Tarihi: | 08/31/2015 |
Durum veya hastalık
Müdahale / tedavi
Drug: SMOFlipid
Drug: Clinoleic
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| 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 |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 23 Weeks İçin 23 Weeks |
| Çalışmaya Uygun Cinsiyetler | All |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | 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. |
Sonuç
Birincil Sonuç Ölçütleri
1. Retinopathy of Prematurity [When the retina is fully vascularised,i.e. at approximately 40 postmenstrual weeks.]
İkincil Sonuç Ölçütleri
1. Brain Growth [At 40 postmenstrual weeks and at 2.5 and 6 years.]
2. Length in cm [At 40 postmenstrual weeks and at 2.5 and 6 years.]
3. Weight in gram [At 40 postmenstrual weeks and at 2.5 and 6 years.]
4. Head circumference in cm [At 40 postmenstrual weeks and at 2.5 and 6 years.]
