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Biomedical subjects

W Michael Southgate

Publications and source records attributed to W Michael Southgate.

10 recordsLinked to original sources

Early inhaled nitric oxide therapy in premature newborns with respiratory failure.

BACKGROUND: The safety and efficacy of early, low-dose, prolonged therapy with inhaled nitric oxide in premature newborns with respiratory failure are uncertain. METHODS: We performed a multicenter, randomized trial involving 793 newborns who were 34 weeks of gestational age or less and had respiratory failure requiring mechanical ventilation. Newborns were randomly assigned to receive either inhaled nitric oxide (5 ppm) or placebo gas for 21 days or until extubation, with stratification according to birth weight (500 to 749 g, 750 to 999 g, or 1000 to 1250 g). The primary efficacy outcome was a composite of death or bronchopulmonary dysplasia at 36 weeks of postmenstrual age. Secondary safety outcomes included severe intracranial hemorrhage, periventricular leukomalacia, and ventriculomegaly. RESULTS: Overall, there was no significant difference in the incidence of death or bronchopulmonary dysplasia between patients receiving inhaled nitric oxide and those receiving placebo (71.6 percent vs. 75.3 percent, P=0.24). However, for infants with a birth weight between 1000 and 1250 g, as compared with placebo, inhaled nitric oxide therapy reduced the incidence of bronchopulmonary dysplasia (29.8 percent vs. 59.6 percent); for the cohort overall, such treatment reduced the combined end point of intracranial hemorrhage, periventricular leukomalacia, or ventriculomegaly (17.5 percent vs. 23.9 percent, P=0.03) and of periventricular leukomalacia alone (5.2 percent vs. 9.0 percent, P=0.048). Inhaled nitric oxide therapy did not increase the incidence of pulmonary hemorrhage or other adverse events. CONCLUSIONS: Among premature newborns with respiratory failure, low-dose inhaled nitric oxide did not reduce the overall incidence of bronchopulmonary dysplasia, except among infants with a birth weight of at least 1000 g, but it did reduce the overall risk of brain injury. (ClinicalTrials.gov number, NCT00006401 [ClinicalTrials.gov].).

Administration, Inhalation↗

Low-dose nitric oxide therapy for persistent pulmonary hypertension: 1-year follow-up.

BACKGROUND: Although inhaled nitric oxide has been shown to reduce the use of extracorporeal membrane oxygenation, there is limited data on its effect on long-term outcomes. OBJECTIVE: The purpose of our study is to report on the 1 year outcome of neonates treated with inhaled nitric oxide compared to a group of neonates who did not receive nitric oxide. METHODS: We have previously reported on the in-hospital outcomes of 248 neonates who were >34 weeks' gestational age and were randomized to receive low-dose inhaled nitric oxide or placebo. Extracorporeal membrane oxygenation was used in 78 (64%) neonates in the control group and in 48 (38%) neonates in the inhaled nitric oxide group (p=0.001). We now report on the outcome of neonates followed to 1 year of age. RESULTS: Of the 248 neonates twenty-four (10%) died before 1 year of age. There was no difference in mortality between the two groups (11% in the control group and 9% in the inhaled nitric oxide group). Of the 224 surviving infants, we were able to contact the parents or guardians of 201 (90%) children. There were no intergroup differences in the numbers of patients reported as requiring medications for pulmonary disease (14% in the control group and 14% in the inhaled nitric oxide group) or the need for supplemental oxygen (1% in the control group and 0% in the inhaled nitric oxide group). The number of neonates reported to have an abnormal neurological examination or developmental delay was also similar in both groups (14% in the control group and 19% in the inhaled nitric oxide group). CONCLUSIONS: The use of low-dose inhaled nitric oxide reduces the use of extracorporeal membrane oxygenation without increasing the incidence of adverse outcomes to 1 year of age.

Administration, Inhalation↗

Evaluation of a flat panel digital radiographic system for low-dose portable imaging of neonates.

The purpose of this study was to evaluate the clinical utility of an investigational flat-panel digital radiography system for low-dose portable neonatal imaging. Thirty image-pairs from neonatal intensive care unit patients were acquired with a commercial Computed Radiography system (Agfa, ADC 70), and with the investigational system (Varian, Paxscan 2520) at one-quarter of the exposure. The images were evaluated for conspicuity and localization of the endings of ancillary catheters and tubes in two observer performance experiments with three pediatric radiologists and three neonatologists serving as observers. The results indicated no statistically significant difference in diagnostic quality between the images from the investigational system and from CR. Given the investigational system's superior resolution and noise characteristics, observer results suggest that the high detective quantum efficiency of flat-panel digital radiography systems can be utilized to decrease the radiation dose/exposure to neonatal patients, although post-processing of the images remains to be optimized. The rapid availability of flat-panel images in portable imaging was found to be an added advantage for timely clinical decision-making.

Catheterization↗

Albuterol delivery with conventional and synchronous ventilation in a neonatal lung model.

OBJECTIVE: To compare the percentage of nebulized albuterol delivered with conventional (intermittent mandatory ventilation) vs. synchronous (assist-control and assist-control with flow synchronization) ventilation in a neonatal lung model. DESIGN: Prospective in vitro laboratory study. SETTING: Research laboratory. SUBJECT: Neonatal lung model. INTERVENTIONS: The model simulated an intubated neonate with a spontaneous respiratory rate of 40, 60, or 80 breaths per minute and compliance and resistance values of bronchopulmonary dysplasia. A VIP Bird ventilator was used for all ventilator modes. Albuterol 2.5 mg was administered with a T Up-Draft II Neb-U-Mist nebulizer attached to a 12.75-cm (10-mL) reservoir of circuit tubing. Albuterol was collected onto a filter (particle retention .05, two-factor analysis of variance). CONCLUSIONS: The percentage of nebulized albuterol delivered to the end of the endotracheal tube in a mechanically ventilated neonatal model was not affected by mode of ventilation under the conditions studied. Further clinical studies are needed to determine whether lung deposition and distribution or clinical efficacy of albuterol is influenced by synchronous ventilation in this patient population.

Journal Article↗

Effects of changing health care financial policy on very low birthweight neonatal outcomes.

BACKGROUND: Our objective was to determine whether perinatal referral patterns and clinical outcomes for very low birthweight infants changed in relation to changing Medicaid financial policies in coastal South Carolina. METHODS: Referral patterns and outcome indicators for very low birthweight infants were compared during two periods in a cohort design. RESULTS: A total of 520 infants were identified over two funding periods. A decrease in the proportion of nonwhite very low birthweight infants was identified. There was an increase in very low birthweight infants with Medicaid funding born outside our level III center. CONCLUSIONS: Changes in financial public policy have been successful in the movement of low risk pregnancies into the private sector. However, an increased proportion of deliveries of very low birthweight infants occurred outside the level III center.

Apgar Score↗

Evaluation of the i-STAT Portable Clinical Analyzer for point-of-care blood testing in the intensive care units of a university children's hospital.

We evaluated the analytical performance of the i-STAT Portable Clinical Analyzer (PCA), a point-of-care testing system consisting of a hand-held analyzer and single-use cartridges that measure different panels of electrolytes, metabolites, blood gases, and hematocrit in 65-100 microl of blood. Our objective was to determine whether PCA measurements at the bedside of patients in the neonatal and pediatric intensive care units of the MUSC Children's Hospital would be as reliable as those performed by the clinical laboratory's primary methods (Radiometer ABL 725 blood gas analyzer; Vitros 750 chemistry analyzer; and Coulter STKS hematology analyzer). Four cartridge types: (a) EC8+ (sodium; potassium; chloride; urea; glucose; pH; blood gases [PO2; pCO2]), (b) EC6+ (sodium; potassium; ionized calcium; glucose; hematocrit; pH), (c) G3+ (pH; PO2; pCO2), and (d) creatinine, were assessed for reproducibility, linearity, and method comparisons using aqueous samples, blood samples supplemented with several analytes, and -225 blood samples from patients. Reproducibility (CV) was good (< 2%) for electrolytes, glucose, urea, and pH, satisfactory (< 6.5%) for blood gases and creatinine, but poor (21%) for hematocrit. Linearity concentrations spanning the clinically relevant ranges were verified for all analytes. Method comparison studies with samples separated into 2 subgroups by patient age (> or < 3 mo) showed that agreement between the PCA and the primary methods was clinically acceptable. After the PCA was implemented for clinical testing, the observation of discrepant results of creatinine concentrations in neonatal blood samples that would have affected clinical management led to a second creatinine comparison study (59 additional samples) and to our eventual discontinuation of the PCA creatinine assay. This problem notwithstanding, the successful implementation of the PCA is attributed to careful analytical evaluations and ongoing communication with the clinical staff.

Blood Chemical Analysis↗

Breastfeeding rates at an urban medical university after initiation of an educational program.

BACKGROUND: Our objective was to improve breastfeeding initiation rates at an urban medical center. METHODS: A breastfeeding educational program for health care providers was developed and implemented in 1995. The outcome variable of interest was the change in breastfeeding initiation rate during 2 periods, 1993-1994 and 1996 to 1999, stratified by weight (> 2,000, 1,500 to 2,000, and < 1,500 g). RESULTS: The breastfeeding initiation rate in 1996 to 1999 for all mothers of newborns admitted to the hospital was 47.1% (4,107/8,724), compared with the 1993-1994 rate of 18.9% (816/4,315). During the second period, the breastfeeding rate among mothers of infants < 1,500 g was 60.8% (468/770), compared with 19.2% (56/293) during the earlier study period. Stratified by weight, the greatest improvement in rates of breastfeeding initiation and at discharge was seen with mothers of preterm infants. CONCLUSION: A breastfeeding educational program that interfaced with medical staff and mothers at an urban medical university was associated with increased rates of breastfeeding initiation.

Academic Medical Centers↗