Clinical trial NCT00226187: A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Low Birth Weight
Keywords: Fatty acids
Human milk
Infant development
Very low birthweight infants
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2005-09-26
Enrollment: 140
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants

Background:

Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Human milk and preterm formulas contain DHA and AA, but at lower concentrations than required to approximate utero accretion rate.

Objective:

To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age.

Design:

A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal centers.

Subjects and methods:

Infants with birth weight \< 1.5 kg are randomized to either an intervention or a control group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per 100 ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid, Martek, USA), while the control oil contains vegetable oil without DHA or AA. Blood samples are collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed for fatty acid pattern using high performance liquid chromatography.


Eligibility criteria: Inclusion Criteria:

* Birth weight \< 1500 g
* Born at one of 4 participating neonatal centers in Norway

Exclusion Criteria:

* Cerebral haemorrhage (stage 3 or 4)
* Major congenital malformations that are supposed to affect growth and development
* Illness that require prolonged parenteral nutrition (\>4 weeks)

Primary outcomes:
measure: Cognitive development
Secondary outcomes:
measure: Growth
measure: Adverse events
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University og Oslo
name: Christian A Drevon, Dr. Med.
role: STUDY_CHAIR
References:
citation: Almaas AN, Tamnes CK, Nakstad B, Henriksen C, Grydeland H, Walhovd KB, Fjell AM, Iversen PO, Drevon CA. Diffusion tensor imaging and behavior in premature infants at 8 years of age, a randomized controlled trial with long-chain polyunsaturated fatty acids. Early Hum Dev. 2016 Apr;95:41-6. doi: 10.1016/j.earlhumdev.2016.01.021. Epub 2016 Mar 2.
citation: Almaas AN, Tamnes CK, Nakstad B, Henriksen C, Walhovd KB, Fjell AM, Due-Tonnessen P, Drevon CA, Iversen PO. Long-chain polyunsaturated fatty acids and cognition in VLBW infants at 8 years: an RCT. Pediatrics. 2015 Jun;135(6):972-80. doi: 10.1542/peds.2014-4094. Epub 2015 May 18.
citation: Henriksen C, Haugholt K, Lindgren M, Aurvag AK, Ronnestad A, Gronn M, Solberg R, Moen A, Nakstad B, Berge RK, Smith L, Iversen PO, Drevon CA. Improved cognitive development among preterm infants attributable to early supplementation of human milk with docosahexaenoic acid and arachidonic acid. Pediatrics. 2008 Jun;121(6):1137-45. doi: 10.1542/peds.2007-1511.