Infant Plasma Sampling Recommended in Clinical Trials for Lactating Mothers

Mother-infant pair studies with infant plasma sampling are the gold standard in trial designs for lactating mothers, but in some situations they should be done in a limited fashion with subsequent follow-up studies, the FDA’s Pediatric Advisory Committee has concluded.

The committee discussed several questions regarding clinical trial designs for lactating mothers and achieved majority consensus without formal votes. The issue on which there seemed to be the most disagreement concerned whether clinical lactation studies should only enroll mother-infant pairs who are exclusively breastfeeding, committee Chairwoman Marsha Rappley said. The majority view was that mother-infant pairs who reflect the general practice in the community should be studied, including mothers who use both breastfeeding and supplements and those who rely solely on breastfeeding.

There was broader consensus on the importance of ethical issues when recruiting healthy volunteers for clinical lactation studies because the need for knowledge must be balanced against the necessity to protect breastfeeding infants from receiving, via their mother’s milk, medicines they would not otherwise be exposed to.

The advisory committee did not want to state categorically that any specific period of time should not be studied during clinical lactation studies, which would happen, for instance, if enrollment were restricted to mother-infant pairs in whom breastfeeding was well established or if a minimum number of weeks postpartum were set before which mother-infant pairs could not be enrolled. Instead, patient enrollment “should depend on a risk-benefit analysis of the study for both the mother and the infant,” Rappley said.