Randomised, double-blind trial of oxytocin nasal spray in mothers expressing breast milk for preterm infants

Mary S Fewtrell ^1*, Kim Loh ¹, Anthea Blake ², Deborah Ridout ¹ and Jane Hawdon ²

¹ Institute of Child Health, United Kingdom
² Elizabeth Garrett Anderson Hospital, United Kingdom

^* To whom correspondence should be addressed. E-mail: m.fewtrell{at}ich.ucl.ac.uk.

Accepted 24 September 2005

Abstract

Introduction:Human milk has significant short and long-term benefits for preterm infants, but mothers may experience difficulties in expressing breast milk for infants too immature or sick to breast-feed. Oxytocin has been used to assist breastfeeding and milk expression, but few data are available to support this intervention in the neonatal unit setting.

Aims:To test the hypothesis that oxytocin nasal spray increases early milk output in mothers expressing milk for preterm infants.

Methods:A randomised double-blind trial of oxytocin nasal spray (100µl per dose) versus placebo was conducted in mothers delivering infants <35 weeks' gestation. Sprays were used before expressing milk using an electric pump up to day 5. Main outcome: total weight of milk expressed while using spray (study powered to detect >1SD difference between groups). Secondary outcomes: pattern of milk production; number of pumping sessions; weight/fat content of milk expressed during a fixed 20 minute period on day 5 ('physiological study'); mother's opinion of expressing and spray assessed by questionnaire.

Results:51 mothers were randomised (27 Oxytocin, 24 Placebo). Total milk production did not differ between groups. Repeated measures ANOVA suggested significantly different patterns of milk production (p=0.001) with initial faster production in the oxytocin group then convergence between groups. Parity did not influence the response to the intervention. No significant differences were seen in milk weight or fat content in the physiological study; nor in mothers' opinions of milk expression and treatment.

Conclusions:Despite marginal differences in the pattern of early milk production, the use of oxytocin nasal spray did not significantly improve outcome. Most mothers believed they were receiving the active spray, suggesting a significant placebo effect (supported by limited data from historical controls) and benefits from the extra breastfeeding support available during the study.

Keywords: breast milk, milk expression, nasal spray, oxytocin, randomised trial

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