Infant feeding bottle design, growth and behaviour: results from a randomised trial

<p>Abstract</p> <p>Background</p> <p>Whether the design of an anti-vacuum infant feeding bottle influences infant milk intake, growth or behavior is unknown, and was the subject of this randomized trial.</p> <p>Methods</p> <p>Subjects</p> <p>63 (36 male) healthy, exclusively formula-fed term infants.</p> <p>Intervention</p> <p>Randomisation to use Bottle A (n = 31), one-way air valve: Philips Avent) versus Bottle B (n = 32), internal venting system: Dr Browns). 74 breast-fed reference infants were recruited, with randomisation (n = 24) to bottle A (n = 11) or B (n = 13) if bottle-feeding was subsequently introduced.</p> <p>Randomisation</p> <p>stratified by gender and parity; computer-based telephone randomisation by independent clinical trials unit.</p> <p>Setting</p> <p>Infant home.</p> <p>Primary outcome measure</p> <p>infant weight gain to 4 weeks.</p> <p>Secondary outcomes</p> <p>(i) milk intake (ii) infant behaviour measured at 2 weeks (validated 3-day diary); (iii) risk of infection; (iv) continuation of breastfeeding following introduction of mixed feeding.</p> <p>Results</p> <p>Number analysed for primary outcome</p> <p>Bottle A n = 29, Bottle B n = 25.</p> <p>Primary outcome</p> <p>There was no significant difference in weight gain between randomised groups (0-4 weeks Bottle A 0.74 (SD 1.2) SDS versus bottle B 0.51 (0.39), mean difference 0.23 (95% CI -0.31 to 0.77).</p> <p>Secondary outcomes</p> <p>Infants using bottle A had significantly less reported fussing (mean 46 versus 74 minutes/day, p < 0.05) than those using bottle B. There was no significant difference in any other outcome measure.</p> <p>Breast-fed reference group</p> <p>There were no significant differences in primary or secondary outcomes between breast-fed and formula fed infants. The likelyhood of breastfeeding at 3 months was not significantly different in infants subsequently randomised to bottle A or B.</p> <p>Conclusion</p> <p>Bottle design may have short-term effects on infant behaviour which merit further investigation. No significant effects were seen on milk intake or growth; confidence in these findings is limited by the small sample size and this needs confirmation in a larger study.</p> <p>Trial registration</p> <p>Clinical Trials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT00325208">NCT00325208</a>.</p>