Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Colorado, Denver
With
This prospective, observational pilot study will identify women within 72 hours of delivery who have a positive urine drug screen for THC and who intend to breastfeed. Eligibility will not be dependent upon the disposition of the infant, either discharged shortly after birth or infants with NICU admission. The study will last six weeks from the time of enrollment. Mothers who consent to participate will complete an in-person survey on marijuana use and exposure during pregnancy at study entry and weekly surveys of current marijuana use. Samples of maternal breast milk, maternal urine, and infant urine will be collected at least three times, but no more than five times during the week (Monday - Friday) during infant hospitalization, dependent on maternal availability. If the infant is discharged from the hospital, visits will occur twice weekly during out-patient clinic visits. The presence of marijuana will be measured by THC concentrations in maternal breast milk, maternal urine and maternal plasma, collected by research staff at each visit. the investigators will ask mothers to refrain from feeding their baby their breast milk for at least 2 weeks after last marijuana exposure, which currently is the minimum time period recommended by lactation consultants in UCH and CHCO Neonatal Intensive Care Units (NICU). If a NICU admitted infant is medically stable to tolerate enteral feedings, they are given feedings either by mouth or by nasogastric feeding tubes, of either expressed breast milk, donor breast milk, or formula. The researchers current practice for infants admitted to the NICU is to offer donor breast to infants whose mothers cannot provide their own breast milk, for numerous reasons. Mothers of infants who are not in the NICU would be encouraged to pump breast milk and dump, for 2 weeks after last THC exposure while using formula until returning to breastfeeding. As this issue is commonly encountered in our clinical practice, the investigators find that many mothers are committed to providing safe feedings to their infants after given education regarding concerns of THC impact on infant development. The time point to safely return to breast milk following THC exposure is unknown, and is a primary aim of this study. There are numerous documented benefits to breast milk, especially in preterm infants however sufficient literature exists to question the safety of THC's effects on the developing brain which may also be particularly susceptible in prematurity. Due to these unknown and understudied but highly concerning effects, The researchers faculty Neonatology practice has agreed to the consensus of refraining from knowingly administering breast milk from mothers actively using THC. Exemptions do occur in certain clinical settings. If this occurs during a mother's study enrollment, subsequent samples would be marked appropriately and the analytical data will be carefully examined.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
