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Double-blind, randomized trial of long-chain polyunsaturated fatty acid supplementation in formula fed to preterm
Mary S Fewtrell1, Ruth Morley, Rebecca A Abbott
1MRC Childhood Nutrition Research Center, Institute of Child Health, London, United Kingdom. m.fewtrell@ich.ucl.ac.uk
Insights
Supplementing preterm formula with long-chain polyunsaturated fatty acids (LCPUFA) did not show significant long-term neurodevelopmental benefits in preterm infants. Breastfed infants demonstrated superior developmental outcomes compared to both formula groups.
Area of Science:
- Neonatal nutrition
- Neurodevelopmental pediatrics
- Clinical trial methodology
Background:
- Preterm infants often require specialized formula for optimal growth and development.
- Long-chain polyunsaturated fatty acids (LCPUFA) are crucial components for brain development.
Purpose of the Study:
- To evaluate the long-term neurodevelopmental effects of LCPUFA supplementation in preterm formula.
- To assess the safety and efficacy of LCPUFA-enriched preterm formula.
Main Methods:
- A double-blind, randomized controlled trial involving 195 formula-fed preterm infants and 88 breast milk-fed infants.
- Neurodevelopmental assessments using Bayley Scales and Knobloch et al. Inventory at 9 and 18 months corrected age.
- Safety outcomes included anthropometry, tolerance, infection, necrotizing enterocolitis, and mortality.
Main Results:
- No significant differences in neurodevelopmental scores between LCPUFA-supplemented and control formula groups.
- A trend towards improved MDI and PDI scores in LCPUFA-fed infants, particularly those born before 30 weeks gestation.
- LCPUFA-supplemented infants were shorter at 18 months; breastfed infants showed significantly better development and growth outcomes.
Conclusions:
- The tested LCPUFA supplementation strategy did not demonstrate clear efficacy for long-term neurodevelopmental advantage.
- Potential benefits in specific subgroups (e.g., <30 weeks gestation) cannot be ruled out.
- Further research is needed to confirm growth effects and explore cognitive function at later ages.
Objective:
We tested the hypothesis that balanced addition of long-chain polyunsaturated fatty acid (LCPUFA) to preterm formula during the first weeks of life would confer long-term neurodevelopmental advantage in a double-blind, randomized, controlled trial of preterm formula with and without preformed LCPUFA.
Methods:
The participants were 195 formula-fed preterm infants (birth weight <1750 g, gestation <37 weeks) from 2 UK neonatal units and 88 breast milk-fed infants. Main outcome measures were Bayley Mental Developmental Index (MDI) and Psychomotor Developmental Index (PDI) at 18 months and Knobloch, Passamanick and Sherrard's Developmental Screening Inventory at 9 months' corrected age. Safety outcome measures were anthropometry at 9 and 18 months, tolerance, infection, necrotizing enterocolitis, and death.
Results:
There were no significant differences in developmental scores between randomized groups, although infants who were fed LCPUFA-supplemented formula showed a nonsignificant 2.6-point (0.25 standard deviation) advantage in MDI and PDI at 18 months, with a greater (nonsignificant) advantage (MDI: 4.5 points; PDI: 5.8 points) in infants below 30 weeks' gestation. LCPUFA-supplemented infants were shorter than control infants at 18 months (difference in length standard deviation score: 0.44; 95% confidence interval: 0.08-0.8). No other significant short- or long-term differences in safety outcomes were observed. Breastfed infants had significantly higher developmental scores at 9 and 18 months than both formula groups and were significantly heavier and longer at 18 months than LCPUFA-supplemented but not control infants.
Conclusions:
With the dose, duration, and preparation of LCPUFA used, efficacy was not demonstrated, although an advantage in later neurodevelopment cannot be excluded by global tests of development up to 18 months, particularly in infants below 30 weeks' gestation. The surprising effect of LCPUFA-supplemented formula on growth 18 months beyond the intervention period needs to be confirmed in other studies using similar supplementation strategies. Additional follow-up of this cohort is critical at an age when more specific tests of cognitive function are possible.
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