Oliguria during hydrocortisone dosage wean in very low birth weight infants.

BACKGROUND: Intravenous hydrocortisone (HC) is often used in very low birth weight infants (VLBW) but can be complicated by oliguria when discontinued or tapered. OBJECTIVES: To determine which factors were associated with oliguria during HC taper. METHODS: We reviewed all VLBW infants who received initial doses of HC ≥ 1 mg/kg/d. The initial dose and duration of HC, and the incidence of oliguria (urine output [UO] < 2 mL/kg/h) during HC taper, were recorded. In those with oliguria, we recorded the change in UO (mL/kg/h), blood pressure, and creatinine. RESULTS: The mean initial HC dose was 2.8 ± 1 mg/kg/d, and the mean total duration of HC therapy was 23 ± 25 days. Oliguria occurred in 24% (13/54) of treated infants. These infants were exposed to higher and longer duration of the initial HC dose than infants without oliguria. Oliguria was predicted by the initial HC dose (odds ratio [OR] 5.8, 95% confidence interval [CI] 1.3-25.8, p = 0.02) and by the number of days at initial dose (OR 1.7, 95%CI 1.1-2.7, p = 0.03). CONCLUSIONS: Oliguria during HC dosage weaning was associated with higher initial HC exposure.

Hemodynamic effects of sodium bicarbonate administration.

OBJECTIVE: To describe the hemodynamic changes that occur with sodium bicarbonate (NaHCO3) administration in premature neonates. STUDY DESIGN: This retrospective study included premature neonates 23 to 31+6 weeks of gestational age who underwent continuous cardiac and cerebral monitoring as participants in prospective trials at our institution, and who received NaHCO3 infused over 30 min in the first 24 h of life. Blood pressure (BP), heart rate, cardiac output (CO), SpO2 and cerebral oximetry (StO2) were captured every 2 s. A baseline was established for all continuous data and averaged over the 10 min before NaHCO3 administration. Baseline was compared with measurements over 10 min epochs until 80 min after administration. Arterial blood gases before and within 1 h of administration were also compared. Significance was set at P<0.05. RESULTS: A total of 36 subjects received NaHCO3 (1.3±0.3 mEq kg-1) in the first 24 h (14±8.5 h) of life. NaHCO3 administration increased pH (7.23 vs 7.28, P<0.01) and decreased base deficit (-8.9 vs -6.8, P<0.01) and PaCO2 (45 vs 43 mm Hg, P<0.05). There was a transient but significant (P<0.05) decrease in systemic BP coinciding with an increase in cerebral oxygenation without an increase in oxygen extraction. CO did not change. CONCLUSION: Early postnatal NaHCO3 administration does not acutely improve CO but does cause transient fluctuations in cerebral and cardiovascular hemodynamics in extremely premature infants.

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary.

This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants.

Modeling drug passage into human milk.

Breastfeeding has positive health consequences for both the breastfed infant and the nursing mother.(1,2) Although information on drug use during lactation is available through sites such as LactMed,(3) available information is often incomplete. Unlike pregnancy, in which large numbers of pregnant women need to be studied to assure safety, measurement of drug concentrations in breastmilk in a relatively few subjects can provide valuable information to assess drug safety. This article reviews methods of measuring and predicting drug passage into breastmilk.