Arachidonic Acid Supplementation in Very Preterm Infants
Condition: Impaired Psychomotor Development
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6), and
      docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of non-myelinated
      cell membranes in the central nervous system, including in the retina, hence the great
      importance of them for appropriate visual and cognitive development.

      In this study, the investigators assessed anthropometric, visual, auditory, and psychomotor
      development in very preterm infants who had diets supplemented with different LCPUFA amount
      of AA to support the importance of sufficient AA values in formula.
    

Detailed description: 
      the investigators carried out a prospective randomized controlled double blinded trial in
      order to study nutritional supplements for preterm infants <1500 grams and/or <32 weeks
      gestational age (GA) who were born in clinical University Hospital of Santiago de Compostela
      (CHUS). They were enrolled for a period of 14 months (from July 2011 to August 2012) and
      followed up from birth until 2 years of age. Milk formulas were provided either as adjunct to
      insufficient amount of breast milk, or as full formula feeding. Breastfeeding was actively
      encouraged. Patients were randomized into one of the two formula groups, depending on the
      type of formula they were to receive. Group A's formula was supplemented with DHA (0.3% of
      all fatty acids) and AA (0.6%) with an ω-6/ω-3 ratio of 2/1. Group B's formula was
      supplemented with DHA (0.3%) and AA (0.3%) with an ω-6/ω-3 ratio of 1/1.

      Primary outcome:

      Assessment of psychomotor development with the Brunet Lézine scale at 2 years of age (Early
      Care Unit CHUS)

      Secondary outcomes:

      Physical examination and anthropometric measurements (weight, length, and head circumference)
      at birth and at 3, 6, 9, 12, 18, and 24 months of age (Neonatology Unit CHUS) Blood levels of
      fatty acids in the first week of life and at 3 months, 6 months, and 12 months. (Metabolic
      Unit. Hospital de Cruces, Bilbao) Visual- and auditory-evoked potentials at 6 and 12 months
      of age (Neurophysiology Unit CHUS)
    

Intervention name(s): Preterm infants formula A; Preterm infants formula B
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Group A will receive a preterm infants formula supplemented with AA (0.6%) and DHA (0.3%) until they have three months corrected age. At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (2/1) until one year corrected age.; Group B will receive other Preterm infants formula very similar, but with AA (0.3%) and DHA (0.3%) also until they have three months corrected age.
At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (1/1) until one year corrected age.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: Arachidonic acid; Omega-6/omega-3 ratio; Preterm infants nutrition