Multi-Center Study to Determine the Role of Fatty Acids in Serum in Preventing Retinopathy of Prematurity (MDM) (MDM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03201588|
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : November 2, 2018
The study is a Randomized Intervention, Multi-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 randomized intervention study of 105+105 (number based on power analysis regarding up to date ROP frequency, see 5.1 and 11.1) infants without major malformations born with a gestational age less than 28 weeks + 0 days will be performed.
|Condition or disease||Intervention/treatment||Phase|
|Ophthalmological Disorder||Dietary Supplement: Formulaid||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized intervention study of 105+105 (number based on power analysis regarding up to date ROP frequency, see 5.1 and 11.1) infants without major malformations born with a gestational age less than 28 weeks + 0 days will be performed.|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Intervention, Multi-Center Study to Determine the Role of Fatty Acids in Serum in Preventing Retinopathy of Prematurity (MDM)|
|Actual Study Start Date :||December 15, 2016|
|Estimated Primary Completion Date :||November 15, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Formulaid 2:1 Arachidonic acid/Docosahexaenoic acid (AA/DHA). Enteral supplement of AA (0,1-1ml) (100mg(kg/day) and DHA (50mg/kg/day) from birth to 40 weeks postmenstrual age in addition to conventional parenteral fatty acid treatment with Clinoleic
Dietary Supplement: Formulaid
Arachidonic acids (AA) Docosahexaenoic Acids(DHA) 2:1
No Intervention: Clinoleic
Sterile fat emulsion [containing a mixture of refined olive oil (approximately 80%) and refined soya oil (approximately 20%)] 200 g, egg lecithin (purified egg phospholipids) 12 g, glycerol 22.5 g, sodium oleate 0.3 g and Water for Injections to 1,000 mL (final pH between 6.0-8.0).
One of the active ingredients, soya oil, contains ascorbyl palmitate as an antioxidant (free radical scavenger), in the concentration of 0.15 mg/g of oil.
- Investigate whether enteral administration of AA and DHA in addition to commonly used regimes with parenteral olive based lipid emulsion (Clinoleic) compared to Clinoleic alone prevents the sight threatening disease Retinopathy of Prematurity (ROP). [ Time Frame: When the retina is fully vascularised, i.e approximately 40 postmenstrual weeks. ]Fatty Acids content (AA/DHA) in children with Retinopathy of Prematurity, change from baseline to 40 weeks postmenstrual weeks. Analyses of phospholipids witch can be done on small amount of blood, is relatively intensitive to short term fluctuations in intake and mirror the composition of many membranes in the body. The analyses will be made by using gas-liquid-chromatography. The method has a coefficient of variability of 1-3% for the Fatty Acids concerned.
- Postnatal serum fatty acid composition in preterm infants with and without AA:DHA supplementation. [ Time Frame: at 0h, 72h, day7, day 14, every other week until postmenstrual age 29 week and thereafter 30, 32, 34, 36 and 40 weeks postmenstrual age ]Postnatal serum fatty acid composition
- Postnatal brain development, as assessed by Magnetic Resonance Imaging (MRI) [ Time Frame: at 40 weeks postmenstrual age and at 2.0 y corrected age and 5.5 y uncorrected age. ]Postnatal brain development, as assessed by Magnetic Resonance Imaging (MRI), Volumetric and Diffusor Tensor Imaging (DTI).
- Outcome in p-glucose [ Time Frame: at 0h, 72h, day7, day 14, every other week until postmenstrual age 29 week and thereafter at 30, 32, 34, 36 and 40 weeks postmenstrual age. ]Neonatal glucose metabolism.
- Outcome in weight in kilograms. [ Time Frame: at day 0, 7, 14, 21 and thereafter every week up to 40 weeks postmenstrual age ]Postnatal growth development, weight in kilograms.
- Outcome in head circumference in centimeters. [ Time Frame: at day 0, 7, 14, 21 and thereafter every week up to 40 weeks postmenstrual age ]Postnatal growth development, head circumference in centimeters.
- Outcome in height in centimeters. [ Time Frame: at day 0, 7, 14, 21 and thereafter every week up to 40 weeks postmenstrual age ]Postnatal growth development, height in centimeter.
- Outcome of neonatal morbidities. [ Time Frame: Reported as adverse event from birth to 40 weeks postmenstrual age. ]Frequency of neonatal morbidities such as bronchopulmonary dysplasia (BPD), cerebral intraventricular hemorrhage (IVH), patent ductus arteriosus (PDA), sepsis and necrotizing enterocolitis (NEC).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201588
|Contact: Ann ca Hellstrom, Professor||0046 ext firstname.lastname@example.org|
|Contact: Carola an Pfeiffer Mosesson, Nurse||0046 ext email@example.com|
|Queen Silvias Childrens Hospital||Recruiting|
|Göteborg, Sweden, 41650|
|Contact: Karin Savman, MD,PhD +46 ext 739940937 firstname.lastname@example.org|
|Contact: Svetlana Najm, MD +46 ext 738999992 email@example.com|
|Contact: David Ley, Professor +46 ext 709264824 firstname.lastname@example.org|
|Contact: Ingrid Pupp, MD,PhD +46 ext 761712021 email@example.com|
|Stockholm, Sweden, 14157|
|Contact: Boubou Hallberg, MD.PhD +46 ext 700021010 firstname.lastname@example.org|
|Contact: Dirk Wackernagel, MD +46 ext 700011758 email@example.com|
|Principal Investigator:||Ann ca Hellstrom, Professor||Göteborg University|
|Principal Investigator:||David Ley, Professor||University of Lund|
|Principal Investigator:||Boubou Hallberg, MD,PhD||University of Karolinska|
|Principal Investigator:||Karin Savman, MD, PhD||Göteborg University|