Safety Aspects of a Randomized Clinical Trial of Maternal and Infant Vitamin D Supplementation by Feeding Type Through 7 Months Postpartum.

Background: The safety of higher dose vitamin D (vitD) supplementation in women who change from exclusive or full breastfeeding to combination feeding or who continue supplementation after cessation of breastfeeding is unknown. Objective: Compare vitD supplementation safety of 6,400 to 400 IU/day and 2,400 IU/day using specific laboratory parameters in postpartum women and their infants through 7 months postpartum by feeding type. Design: In this randomized controlled trial, mothers (exclusively breastfeeding or formula-feeding) were randomized at 4-6 weeks' postpartum to 400, 2,400, or 6,400 IU vitD3 (cholecalciferol)/day for 6 months. Breastfeeding infants in 400 IU group received oral 400 IU vitD3/day; infants in 2,400 and 6,400 IU groups received placebo. Maternal safety parameters (serum vitD, 25-hydroxy-vitamin D [25(OH)D; calcidiol], calcium, phosphorus, intact PTH; urinary calcium/creatinine ratios; and feeding type/changes) were measured monthly; infant parameters were measured at months 1, 4, and 7. Sufficiency was defined as 25(OH)D >50 nmol/L. Feeding type was defined as exclusive/full, combination, or formula-feeding. Data were analyzed using SAS 9.4. Results: Four hundred nineteen mother-infant pairs were randomized into the three treatment groups and followed: 346 breastfeeding and 73 formula-feeding pairs. A dose of 6400 IU/day safely and significantly increased maternal vitD and 25(OH)D from baseline in all mothers regardless of feeding type (p < 0.0001) and was superior to the 400 and 2,400 IU groups in achieving vitD sufficiency with no other differences in safety parameters by treatment or feeding type. Infants in the 2,400 IU group were more likely vitD-deficient than the other groups; otherwise, there were no infant safety parameter differences. Conclusions: While 6,400 IU/day was more effective than 400 or 2,400 IU/day in achieving maternal vitD sufficiency in all feeding groups, the groups did not differ on other safety parameters. Similarly, infant safety parameters did not differ by treatment group or feeding status. Clinical Trial Registration: FDA IND Number: 66,346; ClinicalTrials.gov Number: NCT00412074.

Prenatal Provider Support for Breastfeeding: Changes in Attitudes, Practices and Recommendations Over 22 Years.

BACKGROUND: Prenatal care providers play a central role in breastfeeding outcomes. A survey on obstetricians' support of breastfeeding was conducted in 1993 in Monroe County, NY. Since the landscape of prenatal care and breastfeeding support has changed significantly in the past 2 decades, we repeated and extended this survey in 2015. RESEARCH AIM: To determine changes in breastfeeding support by prenatal care providers over a 20 year period. METHODS: We sent a 46-item on-line or paper questionnaire to all categories of prenatal care providers identified by an online search. A breastfeeding support score was created based on the prior survey, with a maximum score of 3. One point was awarded for: (1) personally discussing breastfeeding; (2) generally suggesting breastfeeding; and (3) commonly receiving questions from patients. Data were analyzed using Chi-square. RESULTS: We had 164 participants (response rate 80%). More current participants, compared to 1993, reported discussing (97% vs. 86%, p < .001) and recommending (93% vs. 80%, p = .001) breastfeeding. Only 10% of 2015 participants gave infant formula samples, compared with 34% in 1993 (p < .0001). Improvement in the support score was seen, with 98% of current participants having high scores compared to 87% in 1993 (p < .001). Similar numbers reported receiving breastfeeding education, though more reported that the education was inadequate (54% vs. 19%, p < .0001). CONCLUSION: Breastfeeding support improved significantly over time, even though breastfeeding education has not improved in quality or quantity. Improving education of prenatal care providers may help future providers be more prepared to support breastfeeding.

Treatment of Narcolepsy with Sodium Oxybate While Breastfeeding: A Case Report.

BACKGROUND: Sodium oxybate is used in the treatment of narcolepsy. Currently no published literature supports its safety during breastfeeding, although it has a favorable pharmacokinetic profile for minimizing exposure. MATERIALS AND METHODS: We report a case of a 27-year-old primigravida with narcolepsy who was taking sodium oxybate for symptom control and contacted our Lactation Study Center for advice. Based on our current pharmacokinetic knowledge, she was advised to avoid breastfeeding 4 hours after a dose. RESULTS: Follow-up phone interviews were done and the patient reported that the feeding schedule was manageable, and she was able to exclusively breastfeed for 6 months of her infant's life. Based on pediatric records, her infant's growth and development were excellent. There were no noted side effects of the medication for the infant. CONCLUSIONS: This is the first report to our knowledge of breastfeeding during maternal therapy with sodium oxybate, which appears to be compatible with safe, exclusive breastfeeding when managed appropriately.

Impact of Donor Milk Availability on Breast Milk Use and Necrotizing Enterocolitis Rates.

OBJECTIVES: To examine the availability of donor human milk (DHM) in a population-based cohort and assess whether the availability of DHM was associated with rates of breast milk feeding at NICU discharge and rates of necrotizing enterocolitis (NEC). METHODS: Individual patient clinical data for very low birth weight infants from the California Perinatal Quality Care Collaborative were linked to hospital-level data on DHM availability from the Mothers' Milk Bank of San José for 2007 to 2013. Trends of DHM availability were examined by level of NICU care. Hospitals that transitioned from not having DHM to having DHM availability during the study period were examined to assess changes in rates of breast milk feeding at NICU discharge and NEC. RESULTS: The availability of DHM increased from 27 to 55 hospitals during the study period. The availability increased for all levels of care including regional, community, and intermediate NICUs, with the highest increase occurring in regional NICUs. By 2013, 81.3% of premature infants cared for in regional NICUs had access to DHM. Of the 22 hospitals that had a clear transition to having availability of DHM, there was a 10% increase in breast milk feeding at NICU discharge and a concomitant 2.6% decrease in NEC rates. CONCLUSIONS: The availability of DHM has increased over time and has been associated with positive changes including increased breast milk feeding at NICU discharge and decrease in NEC rates.

Maternal Versus Infant Vitamin D Supplementation During Lactation: A Randomized Controlled Trial.

OBJECTIVE: Compare effectiveness of maternal vitamin D3 supplementation with 6400 IU per day alone to maternal and infant supplementation with 400 IU per day. METHODS: Exclusively lactating women living in Charleston, SC, or Rochester, NY, at 4 to 6 weeks postpartum were randomized to either 400, 2400, or 6400 IU vitamin D3/day for 6 months. Breastfeeding infants in 400 IU group received oral 400 IU vitamin D3/day; infants in 2400 and 6400 IU groups received 0 IU/day (placebo). Vitamin D deficiency was defined as 25-hydroxy-vitamin D (25(OH)D) <50 nmol/L. 2400 IU group ended in 2009 as greater infant deficiency occurred. Maternal serum vitamin D, 25(OH)D, calcium, and phosphorus concentrations and urinary calcium/creatinine ratios were measured at baseline then monthly, and infant blood parameters were measured at baseline and months 4 and 7. RESULTS: Of the 334 mother-infant pairs in 400 IU and 6400 IU groups at enrollment, 216 (64.7%) were still breastfeeding at visit 1; 148 (44.3%) continued full breastfeeding to 4 months and 95 (28.4%) to 7 months. Vitamin D deficiency in breastfeeding infants was greatly affected by race. Compared with 400 IU vitamin D3 per day, 6400 IU/day safely and significantly increased maternal vitamin D and 25(OH)D from baseline (P < .0001). Compared with breastfeeding infant 25(OH)D in the 400 IU group receiving supplement, infants in the 6400 IU group whose mothers only received supplement did not differ. CONCLUSIONS: Maternal vitamin D supplementation with 6400 IU/day safely supplies breast milk with adequate vitamin D to satisfy her nursing infant's requirement and offers an alternate strategy to direct infant supplementation.

The discordance between planned use and actual receipt of immediate postpartum depot medroxyprogesterone among low-income women.

BACKGROUND: This study describes the patterns of planned use and actual receipt of immediate postpartum depot medroxyprogesterone (DMPA) prior to hospital discharge among low-income breastfeeding initiators. MATERIALS AND METHODS: Bivariate analyses among DMPA recipients by prenatal planned/unplanned use and the sensitivity of DMPA self-report relative to pharmacologic record were calculated. RESULTS: Among immediate postpartum DMPA recipients (n=58), 72.4% (n=42) did not plan to use DMPA. The sensitivity of self-reported DMPA use was 89.7% (95% confidence interval, 85.2, 94.2). CONCLUSIONS: Clinically, it is unclear if the immediate postpartum period is the appropriate time to obtain consent and administer a long-acting contraceptive method. In our sample, women accurately recalled receiving DMPA in the immediate postpartum period. However, the majority did not plan to use this contraceptive method. Further high-quality qualitative and quantitative research regarding women's contraceptive plans and perception of the postpartum DMPA consent process and the healthcare provider's attitudes regarding consent and prescription of immediate postpartum DMPA are warranted.