A Fatty Acids Study in Preventing Retinopathy of Prematurity

NCT02760472 | Completed Phase 3 DMC

• 1 other identifier: 2008-000046-31
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of Prematurity; Preterm; Fatty acids

Outcome Measures

Primary Outcomes (1)

• Retinopathy of Prematurity

  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.

  When the retina is fully vascularised,i.e. at approximately 40 postmenstrual weeks.

Secondary Outcomes (4)

• Brain Growth

  At 40 postmenstrual weeks and at 2.5 and 6 years.

• Length in cm

  At 40 postmenstrual weeks and at 2.5 and 6 years.

• Weight in gram

  At 40 postmenstrual weeks and at 2.5 and 6 years.

• Head circumference in cm

  At 40 postmenstrual weeks and at 2.5 and 6 years.

Study Arms (2)

Clinoleic

ACTIVE COMPARATOR

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

Drug: Clinoleic

SMOFlipid

EXPERIMENTAL

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

Drug: SMOFlipid

Interventions

SMOFlipid DRUG

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

SMOFlipid

Clinoleic DRUG

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

Clinoleic

Eligibility Criteria

• Age: 23 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carola Pfeiffer-Mosesson: lead

Related Publications (4)

• Cakir B, Hellstrom W, Tomita Y, Fu Z, Liegl R, Winberg A, Hansen-Pupp I, Ley D, Hellstrom A, Lofqvist C, Smith LE. IGF1, serum glucose, and retinopathy of prematurity in extremely preterm infants. JCI Insight. 2020 Oct 2;5(19):e140363. doi: 10.1172/jci.insight.140363.

  PMID: 33004691 DERIVED

• Nilsson AK, Pedersen A, Malmodin D, Lund AM, Hellgren G, Lofqvist C, Pupp IH, Hellstrom A. Serum choline in extremely preterm infants declines with increasing parenteral nutrition. Eur J Nutr. 2021 Mar;60(2):1081-1089. doi: 10.1007/s00394-020-02312-2. Epub 2020 Jun 25.

  PMID: 32588218 DERIVED

• Lundgren P, Hellgren G, Pivodic A, Savman K, Smith LEH, Hellstrom A. Erythropoietin serum levels, versus anaemia as risk factors for severe retinopathy of prematurity. Pediatr Res. 2019 Aug;86(2):276-282. doi: 10.1038/s41390-018-0186-6. Epub 2018 Sep 18.

  PMID: 30297879 DERIVED

• Lofqvist CA, Najm S, Hellgren G, Engstrom E, Savman K, Nilsson AK, Andersson MX, Hard AL, Smith LEH, Hellstrom A. Association of Retinopathy of Prematurity With Low Levels of Arachidonic Acid: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2018 Mar 1;136(3):271-277. doi: 10.1001/jamaophthalmol.2017.6658.

  PMID: 29423508 DERIVED

Related Links

• Homepage

MeSH Terms

Conditions

Retinopathy of Prematurity; Premature Birth

Interventions

SMOFlipid; ClinOleic

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Carola Pfeiffer-Mosesson, RN

  The Queen Silvia Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Nurse

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: May 3, 2016
• Study Start: March 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 3, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share