Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 293 for:    retinopathy of prematurity

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
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Göteborg University

Brief Summary:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Formulaid
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all the following inclusion criteria to be permitted into this study:

  • Signed informed consent from parents/guardians;
  • Subject must be born before 28 weeks of gestation

Exclusion Criteria:

Subjects presenting with any of the following will be excluded from the study:

  • Detectable clinical gross malformation;
  • Known or suspected chromosomal abnormality, genetic disorder, or syndrome, 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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Ann ca Hellstrom, Professor 0046 ext 768979196 ann.hellstrom@medfak.gu.se
Contact: Carola an Pfeiffer Mosesson, Nurse 0046 ext 709126127 carola.pfeiffer-mosesson@gu.se

Locations
Layout table for location information
Sweden
Queen Silvias Childrens Hospital Recruiting
Göteborg, Sweden, 41650
Contact: Karin Savman, MD,PhD    +46 ext 739940937    karin.savman@vgregion.se   
Contact: Svetlana Najm, MD    +46 ext 738999992    svatlana.najm@vgregion.se   
Skanes Universitetssjukhus Recruiting
Lund, Sweden
Contact: David Ley, Professor    +46 ext 709264824    david.ley@med.lu.se   
Contact: Ingrid Pupp, MD,PhD    +46 ext 761712021    ingrid.pupp@med.lu.se   
KI Recruiting
Stockholm, Sweden, 14157
Contact: Boubou Hallberg, MD.PhD    +46 ext 700021010    boubou.hallberg@karolinska.se   
Contact: Dirk Wackernagel, MD    +46 ext 700011758    dirk.wackernagel@karolinska.se   
Sponsors and Collaborators
Göteborg University
The Swedish Research Council
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03201588     History of Changes
Other Study ID Numbers: 303-11
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Göteborg University:
Retinopathy of Prematurity

Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases