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Effect of an Intervention to Promote Breastfeeding on Asthma, Lung Function, and Atopic Eczema at Age 16 Years: Follow-up of the PROBIT Randomized Trial.

  • Flohr, Carsten1
  • Henderson, A John2
  • Kramer, Michael S3
  • Patel, Rita2
  • Thompson, Jennifer4
  • Rifas-Shiman, Sheryl L4
  • Yang, Seungmi3, 5
  • Vilchuck, Konstantin6
  • Bogdanovich, Natalia6
  • Hameza, Mikhail6
  • Martin, Richard M2, 7
  • Oken, Emily4
  • 1 Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, Division of Genetics and Molecular Medicine, King's College London and Guy's & St Thomas' National Health Service Foundation Trust, London, England.
  • 2 School of Social and Community Medicine, University of Bristol, Bristol, England.
  • 3 Department of Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Quebec, Canada. , (Canada)
  • 4 Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
  • 5 Department of Pediatrics, McGill University Faculty of Medicine, Montreal, Quebec, Canada. , (Canada)
  • 6 National Research and Applied Medicine Mother and Child Centre, Minsk, Republic of Belarus. , (Belarus)
  • 7 Medical Research Council Integrative Epidemiology Unit, University of Bristol, Bristol, England.
Published Article
JAMA pediatrics
Publication Date
Jan 02, 2018
DOI: 10.1001/jamapediatrics.2017.4064
PMID: 29131887


Atopic diseases, including asthma and atopic eczema, are the most common chronic conditions of childhood. To investigate whether an intervention to promote prolonged and exclusive breastfeeding protects against asthma, atopic eczema, and low lung function in adolescence. Follow-up of the Promotion of Breastfeeding Intervention Trial (PROBIT), a cluster randomized trial in 30 Belarusian maternity hospitals and affiliated polyclinics; recruitment of 17 046 healthy term infants took place from June 15, 1996, to December 31, 1997. Data analysis was conducted from May 9, 2016, to April 21, 2017. The primary analytic approach was by modified intention-to-treat analysis. Randomization to receive a breastfeeding promotion intervention vs usual care. Spirometry and flexural eczema on standardized skin examination by study pediatricians were the primary outcomes; secondary outcomes were self-reported asthma diagnosis ever, and wheezing and flexural eczema symptoms in the previous year. A total of 13 557 (79.5%) participants were followed up from September 15, 2012 to July 15, 2015. The intervention (7064 [79.7%]) and control (6493 [79.4%]) groups were similar at follow-up (3590 [50.8%] and 3391 [52.2%] male; mean [SD] age, 16.2 [0.6] and 16.1 [0.5] years, respectively). In the intervention group, 0.3% (21 of 7064) had flexural eczema on skin examination and mean (SD) forced expiratory volume in the first second of expiration/forced vital capacity (FEV1/FVC) ratio z score was -0.10 (1.82), compared with 0.7% (43 of 6493) and 0.35 (1.34), respectively, in the control group. In modified intention-to-treat analysis, accounting for clustering by polyclinic, a 54% lower risk of flexural eczema on skin examination was observed in the intervention compared with the control group (odds ratio [OR], 0.46; 95% CI, 0.25 to 0.86). Self-reported flexural eczema symptoms in the past year (OR, 0.57; 95% CI, 0.27 to 1.18), asthma (OR, 0.76; 95% CI, 0.47 to 1.23), and wheezing in the past year (OR, 0.66; 95% CI, 0.37 to 1.18) were less frequently reported in the intervention compared with the control group, but 95% CIs were wide and included the null. There was no significant difference in the FEV1/FVC ratio z score (β -0.15; 95% CI, -0.76 to 0.45). All results were similar with additional adjustment for baseline characteristics, on instrumental variable analysis, and with multiple imputation among all 17 046 randomized participants. A breastfeeding promotion intervention reduced flexural dermatitis risk but had no detectable effect on lung function or questionnaire-derived measures of atopic eczema or asthma in adolescence in a setting where atopic eczema and allergies are rare. Identifier: NCT01561612.

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