NCT03555019

Brief Summary

The primary objective of this double-blind randomized study is to assess the effects of an early, enhanced supply of the essential fatty acids (FAs) arachidonic acid (ARA) and docosahexaenoic acid (DHA) on brain maturation, clinical outcomes and quality of growth in immature infants (gestational age \<29 weeks) as compared to standard nutrient supply.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
38mo left

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Apr 2018May 2029

First Submitted

Initial submission to the registry

April 10, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

April 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2029

Expected
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

3.1 years

First QC Date

April 10, 2018

Last Update Submit

September 7, 2021

Conditions

Immature InfantEssential Fatty Acid Deficiency

Keywords

Brain maturationPostnatal growth

Outcome Measures

Primary Outcomes (1)

  • Brain maturation assessed by magnetic resonance imaging (MRI)

    MRI with spectroscopy (MRS) and diffusion tensor imaging (DTI) will be used to examine myelinisation and quantification of anatomical structures as well as neuronal integrity and inflammation

    40 weeks postmenstrual age (PMA)

Secondary Outcomes (17)

  • Weight gain

    Weight will be recorded until 36 weeks PMA and at 3, 6, 12 and 24 months and 8 years corrected age.

  • Growth

    Length and HC will be recorded until 36 weeks PMA and at 3, 6, 12 and 24 months and 8 years corrected age.

  • Body composition

    At 36 weeks PMA, 3 months and 2 years corrected age

  • Neonatal morbidities associated with inflammation

    From birth til 36 weeks PMA

  • Cerebral Background Activity evaluated by Electroencephalogram (EEG)

    First week of life, 36 weeks PMA and 2 years corrected age (CA)

  • +12 more secondary outcomes

Study Arms (2)

Formulaid

EXPERIMENTAL

The intervention group will receive enteral supplementation with Formulaid containing ARA and DHA at a ratio of 2:1, from birth until 36 weeks PMA

Dietary Supplement: Formulaid

MCT-oil

ACTIVE COMPARATOR

The control group will receive enteral supplementation with MCT oil containing coconut and/or palm kern oil, from birth until 36 weeks PMA

Dietary Supplement: MCT-oil

Interventions

FormulaidDIETARY_SUPPLEMENT

Supplementation with ARA and DHA

Formulaid
MCT-oilDIETARY_SUPPLEMENT

Supplementation with medium chain fatty acids

MCT-oil

Eligibility Criteria

AgeUp to 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Extremely preterm infants born at Oslo University Hospital (OUH)
  • Gestational age (GA) \< 29 weeks
  • Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to good clinical practice (GCP) and national/local regulations

You may not qualify if:

  • Major congenital malformations which will affect growth and development
  • Chromosomal abnormalities and other genetic diseases
  • Critical illness with short life expectancy as defined by the study physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (6)

  • Gunnarsdottir G, Rossholt ME, Nordvik T, Wendel K, Aas MF, Skarbo AB, Aulie VS, Stiris T, Ramm-Pettersen A, Pfeiffer HC, Moltu SJ. High dose arachidonic and docosahexaenoic acid in very preterm infants and neurodevelopment at 2 years - A double-blind randomized controlled trial. Clin Nutr. 2025 Aug;51:198-205. doi: 10.1016/j.clnu.2025.05.019. Epub 2025 Jun 4.

    PMID: 40580806DERIVED

  • Moltu SJ, Nordvik T, Rossholt ME, Wendel K, Chawla M, Server A, Gunnarsdottir G, Pripp AH, Domellof M, Bratlie M, Aas M, Huppi PS, Lapillonne A, Beyer MK, Stiris T, Maximov II, Geier O, Pfeiffer H. Arachidonic and docosahexaenoic acid supplementation and brain maturation in preterm infants; a double blind RCT. Clin Nutr. 2024 Jan;43(1):176-186. doi: 10.1016/j.clnu.2023.11.037. Epub 2023 Nov 29.

    PMID: 38061271DERIVED

  • Rossholt ME, Bratlie M, Wendel K, Aas MF, Gunnarsdottir G, Fugelseth D, Pripp AH, Domellof M, Stordal K, Stiris T, Moltu SJ. Effect of arachidonic and docosahexaenoic acid supplementation on quality of growth in preterm infants: A secondary analysis of a randomized controlled trial. Clin Nutr. 2023 Dec;42(12):2311-2319. doi: 10.1016/j.clnu.2023.10.005. Epub 2023 Oct 17.

    PMID: 37856920DERIVED

  • Wendel K, Aas MF, Gunnarsdottir G, Rossholt ME, Bratlie M, Nordvik T, Landsend ECS, Fugelseth D, Domellof M, Pripp AH, Stiris T, Moltu SJ. Effect of arachidonic and docosahexaenoic acid supplementation on respiratory outcomes and neonatal morbidities in preterm infants. Clin Nutr. 2023 Jan;42(1):22-28. doi: 10.1016/j.clnu.2022.11.012. Epub 2022 Nov 17.

    PMID: 36473425DERIVED

  • Hortensius LM, Hellstrom W, Savman K, Heckemann RA, Bjorkman-Burtscher IM, Groenendaal F, Andersson MX, Nilsson AK, Tataranno ML, van Elburg RM, Hellstrom A, Benders MJNL. Serum docosahexaenoic acid levels are associated with brain volumes in extremely preterm born infants. Pediatr Res. 2021 Dec;90(6):1177-1185. doi: 10.1038/s41390-021-01645-w. Epub 2021 Aug 14.

    PMID: 34392310DERIVED

  • Wendel K, Pfeiffer HCV, Fugelseth DM, Nestaas E, Domellof M, Skalhegg BS, Elgstoen KBP, Rootwelt H, Pettersen RD, Pripp AH, Stiris T, Moltu SJ; ImNuT Collaboration Group. Effects of nutrition therapy on growth, inflammation and metabolism in immature infants: a study protocol of a double-blind randomized controlled trial (ImNuT). BMC Pediatr. 2021 Jan 7;21(1):19. doi: 10.1186/s12887-020-02425-x.

    PMID: 33407269DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Tom Stiris, MD, ass prof

    Departement of Neonatal Intensive care, Oslo University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Double-blind, randomized-controlled. Parallel group, single center trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Principal Investigator

Study Record Dates

First Submitted

April 10, 2018

First Posted

June 13, 2018

Study Start

April 13, 2018

Primary Completion

May 28, 2021

Study Completion (Estimated)

May 30, 2029

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available within 6 months of study completion

Locations

NO(1)