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Infant formula supplementation with long-chain polyunsaturated fatty acids has no effect on Bayley developmental scores at 18 months of age--IPD meta-analysis of 4 large clinical trials.
J Pediatr Gastroenterol Nutr 2010; 50(1):79-84JP

Abstract

OBJECTIVES

To find out whether supplementation of formula milk by long-chain polyunsaturated fatty acids (LCPUFA) affects neurodevelopment at 18 months of age in term or preterm infants by an individual patient data (IPD) meta-analysis.

MATERIALS AND METHODS

Data of 870 children from 4 large randomised clinical trials for formula milk with and without LCPUFAs allowed for assessing the effect of LCPUFA with adjustment for potential confounders and extensive subgroup analysis on prematurity, LCPUFA source, and dosage. Any additional clinical trials examining the effect of LCPUFA supplementation on Bayley Scales of Infant Development at 18 months were regarded as relevant. Two relevant studies were identified by MEDLINE, but were not available to us. An IPD meta-analysis was performed with subgroup analyses by preterm delivery, very low birth weight (<1500 g), trials with higher amounts of docosahexaenoic acid (DHA) and arachidonic acid (AA), and specific sources of LCPUFA. The sample size of 870 children was sufficient to detect clinically relevant differences in Bayley Scales even in subgroups.

RESULTS

There were no significant differences in mental or psychomotor developmental indexes between LCPUFA-supplemented and control groups for all children or in subgroups. This was confirmed with adjustment for the possible confounders: sex, gestational age, birth weight, maternal age, and maternal smoking. The adjusted mean differences in mental developmental index and psychomotor developmental index for all of the children were -0.8 (95% confidence interval -2.8 to 1.2) and -1.0 (-2.7 to 0.7), respectively.

CONCLUSIONS

These data based on considerable sample size provide substantial evidence that LCPUFA supplementation of infant formula does not have a clinically meaningful effect on the neurodevelopment as assessed by Bayley scores at 18 months. Inclusion of all relevant data should not have led to differing conclusions except, possibly, for very-low-birth-weight infants.

Authors+Show Affiliations

Division of Epidemiology, Institute of Social Paediatrics and Adolescent Medicine, Ludwig-Maximilians University of Munich, Munich, Germany. andreas.beyerlein@med.uni-muenchen.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19881391

Citation

Beyerlein, Andreas, et al. "Infant Formula Supplementation With Long-chain Polyunsaturated Fatty Acids Has No Effect On Bayley Developmental Scores at 18 Months of age--IPD Meta-analysis of 4 Large Clinical Trials." Journal of Pediatric Gastroenterology and Nutrition, vol. 50, no. 1, 2010, pp. 79-84.
Beyerlein A, Hadders-Algra M, Kennedy K, et al. Infant formula supplementation with long-chain polyunsaturated fatty acids has no effect on Bayley developmental scores at 18 months of age--IPD meta-analysis of 4 large clinical trials. J Pediatr Gastroenterol Nutr. 2010;50(1):79-84.
Beyerlein, A., Hadders-Algra, M., Kennedy, K., Fewtrell, M., Singhal, A., Rosenfeld, E., ... von Kries, R. (2010). Infant formula supplementation with long-chain polyunsaturated fatty acids has no effect on Bayley developmental scores at 18 months of age--IPD meta-analysis of 4 large clinical trials. Journal of Pediatric Gastroenterology and Nutrition, 50(1), pp. 79-84. doi:10.1097/MPG.0b013e3181acae7d.
Beyerlein A, et al. Infant Formula Supplementation With Long-chain Polyunsaturated Fatty Acids Has No Effect On Bayley Developmental Scores at 18 Months of age--IPD Meta-analysis of 4 Large Clinical Trials. J Pediatr Gastroenterol Nutr. 2010;50(1):79-84. PubMed PMID: 19881391.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Infant formula supplementation with long-chain polyunsaturated fatty acids has no effect on Bayley developmental scores at 18 months of age--IPD meta-analysis of 4 large clinical trials. AU - Beyerlein,Andreas, AU - Hadders-Algra,Mijna, AU - Kennedy,Katherine, AU - Fewtrell,Mary, AU - Singhal,Atul, AU - Rosenfeld,Eva, AU - Lucas,Alan, AU - Bouwstra,Hylco, AU - Koletzko,Berthold, AU - von Kries,Rüdiger, PY - 2009/11/3/entrez PY - 2009/11/3/pubmed PY - 2010/6/18/medline SP - 79 EP - 84 JF - Journal of pediatric gastroenterology and nutrition JO - J. Pediatr. Gastroenterol. Nutr. VL - 50 IS - 1 N2 - OBJECTIVES: To find out whether supplementation of formula milk by long-chain polyunsaturated fatty acids (LCPUFA) affects neurodevelopment at 18 months of age in term or preterm infants by an individual patient data (IPD) meta-analysis. MATERIALS AND METHODS: Data of 870 children from 4 large randomised clinical trials for formula milk with and without LCPUFAs allowed for assessing the effect of LCPUFA with adjustment for potential confounders and extensive subgroup analysis on prematurity, LCPUFA source, and dosage. Any additional clinical trials examining the effect of LCPUFA supplementation on Bayley Scales of Infant Development at 18 months were regarded as relevant. Two relevant studies were identified by MEDLINE, but were not available to us. An IPD meta-analysis was performed with subgroup analyses by preterm delivery, very low birth weight (<1500 g), trials with higher amounts of docosahexaenoic acid (DHA) and arachidonic acid (AA), and specific sources of LCPUFA. The sample size of 870 children was sufficient to detect clinically relevant differences in Bayley Scales even in subgroups. RESULTS: There were no significant differences in mental or psychomotor developmental indexes between LCPUFA-supplemented and control groups for all children or in subgroups. This was confirmed with adjustment for the possible confounders: sex, gestational age, birth weight, maternal age, and maternal smoking. The adjusted mean differences in mental developmental index and psychomotor developmental index for all of the children were -0.8 (95% confidence interval -2.8 to 1.2) and -1.0 (-2.7 to 0.7), respectively. CONCLUSIONS: These data based on considerable sample size provide substantial evidence that LCPUFA supplementation of infant formula does not have a clinically meaningful effect on the neurodevelopment as assessed by Bayley scores at 18 months. Inclusion of all relevant data should not have led to differing conclusions except, possibly, for very-low-birth-weight infants. SN - 1536-4801 UR - https://www.unboundmedicine.com/medline/citation/19881391/Infant_formula_supplementation_with_long_chain_polyunsaturated_fatty_acids_has_no_effect_on_Bayley_developmental_scores_at_18_months_of_age__IPD_meta_analysis_of_4_large_clinical_trials_ L2 - http://Insights.ovid.com/pubmed?pmid=19881391 DB - PRIME DP - Unbound Medicine ER -