Richard J. Powers

Prospective evaluation of postnatal steroid administration: a 1-year experience from the California Perinatal Quality Care Collaborative.

OBJECTIVE. Postnatal steroids (PNSs) are used frequently to prevent or treat chronic lung disease (CLD) in the very low birth weight (VLBW) infant, and their use continues despite concerns regarding an increased incidence of longer-term neurodevelopmental abnormalities in such infants. More recently, there has been a suggestion that corticosteroids may be a useful alternative therapy for hypotension in VLBW infants, but there have been no prospective reports of such use for a current cohort of VLBW infants. METHODS. The California Perinatal Quality Care Collaborative (CPQCC) requested members to supplement their routine Vermont Oxford Network data collection with additional information on any VLBW infant treated during their hospital course with PNS, for any indication. The indication, actual agent used, total initial daily dose, age at treatment, type of respiratory support, mean airway pressure, fraction of inspired oxygen, and duration of first dosing were recorded. RESULTS. From April 2002 to March 2003 in California, 22 of the 62 CPQCC hospitals reported supplemental data, if applicable, from a cohort of 1401 VLBW infants (expanded data group [EDG]), representing 33.2% of the VLBW infants registered with the CPQCC during the 12-month period. PNSs for CLD were administered to 8.2% of all VLBW infants in 2003, 8.6% of infants in the 42 hospitals that did not submit supplemental data (routine data-set group, compared with 7.6% in EDG hospitals). Of the 1401 VLBW infants in the EDG, 19.3% received PNSs; 3.6% received PNSs for only CLD, 11.8% for only non-CLD indications, and 4.0% for both indications. At all birth weight categories, non-CLD use was significantly greater than CLD use. The most common non-CLD indication was hypotension, followed by extubation stridor, for which 36 (16.3%) infants were treated. For hypotension, medications used were hydrocortisone followed by dexamethasone. Infants treated with PNSs exclusively for hypotension had a significantly higher incidence of intraventricular hemorrhage, periventricular leukomalacia, and death when compared with infants treated only for CLD or those who did not receive PNSs. CONCLUSIONS. The common early use of hydrocortisone for hypotension and the high morbidity and mortality in children receiving such treatment has not been recognized previously and prospective trials evaluating the short- and long-term risk/benefit of such treatment are urgently required.

Randomized trial of long-term diuretic therapy for infants with oxygen-dependent bronchopulmonary dysplasia ☆ ☆☆ ★ ★★

STUDY OBJECTIVE To determine whether long-term oral diuretic therapy would improve the pulmonary function of preterm infants with bronchopulmonary dysplasia. DESIGN Randomized, double-blind, placebo-controlled study. SETTING Level III intensive care nursery. INTERVENTION We randomly selected 43 stable patients with oxygen-dependent bronchopulmonary dysplasia to receive either orally administered spironolactone and chlorothiazide or placebo. These drugs were continued until the patients no longer required supplemental oxygen. Both groups received furosemide as needed. MEASUREMENTS AND RESULTS Each infant had pulmonary function tests at study entry, 4 weeks after study entry, 1 week and 8 weeks after being weaned to room air and off study drugs, and at 1 year of corrected age. Pulmonary function tests include dynamic pulmonary compliance, airway resistance, thoracic gas volume, and maximal expiratory flow at functional residual capacity; most of the infants had functional residual capacity measured. Between the first and second pulmonary function tests (while the infants were receiving diuretic or placebo), the infants in the diuretic group had a significant improvement in dynamic pulmonary compliance (46%; p < 0.001) and airway resistance (31%; p < 0.05); there were no changes in compliance or resistance in the placebo group. Although patients in both the diuretic and the placebo groups required progressively less supplemental oxygen, by 4 weeks after study entry the patients in the diuretic group needed less supplemental oxygen than did those in the placebo group (p < 0.01). There were no significant differences in results of serial pulmonary function tests in either group after discontinuation of diuretic therapy. Despite the significant differences in pulmonary function between the two groups, there was no significant difference between them in the total number of days that supplemental oxygen was required. Significantly more infantsin the placebo group received more than 10 doses of furosemide on an as-needed basis. CONCLUSIONS Long-term diuretic therapy in stable infants with oxygen-dependent bronchopulmonary dysplasia, after extubation, improves their pulmonary function and decreases their fractional inspired oxygen requirement, but does not decrease the number of days that they require supplemental oxygen. The improvement in pulmonary function associated with diuretic therapy is not maintained after treatment is discontinued.

Evaluation and Development of Potentially Better Practices to Improve Pain Management of Neonates

OBJECTIVE Despite increased knowledge, improved options, and regulatory man-dates, pain management of neonates remains inadequate, promoted by the ineffective translation of research data into clinical practice. The Neonatal Intensive Care Quality Improvement Collaborative 2002 was created to provide participating NICUs the tools necessary to translate research, related to prevention and treat-ment of neonatal pain, into practice. The objective for this study was to use proven quality improvement methods to develop a process to improve neonatal pain management collaboratively. METHODS Twelve members of the Neonatal Intensive Care Quality Improvement Collaborative 2002 formed an exploratory group to improve neonatal pain management. The exploratory group established group and site-specific goals and outcome measures for this project. Group members crafted a list of potentially better practices on the basis of the available literature, encouraged implementation of the potentially better practices at individual sites, developed a database for sharing information, and measured baseline outcomes. RESULTS The goal “improve the assessment and management of infants experiencing pain in the NICU” was established. In addition, each site within the group identified local goals for improvement in neonatal pain management. Data from 7 categories of neonates (N = 277) were collected within 48 hours of NICU admission to establish baseline data for clinical practices. Ten potentially better practices were developed for prioritized pain conditions, and 61 potentially better practices were newly implemented at the 12 participating sites. Various methods were used for pain assessment at the participating centers. At baseline, heel sticks were used more frequently than peripheral intravenous insertions or venipunctures, with substantial variability in the number of avoidable procedures between centers. Pain was assessed in only 17% of procedures, and analgesic interventions were performed in 19% of the procedures at baseline. CONCLUSIONS Collaborative use of quality improvement methods resulted in the creation of self-directed, efficient, and effective processes to improve neonatal pain management. Group establishment of potentially better practices, collective and site-specific goals, and extensive baseline data resulted in accelerated implementation of clinical practices that would not likely occur outside a collaborative setting.

Implementation Methods for Delivery Room Management: A Quality Improvement Comparison Study

BACKGROUND: There is little evidence to compare the effectiveness of large collaborative quality improvement versus individual local projects. METHODS: This was a prospective pre-post intervention study of neonatal resuscitation practice, comparing 3 groups of nonrandomized hospitals in the California Perinatal Quality Care Collaborative: (1) collaborative, hospitals working together through face-to-face meetings, webcasts, electronic mailing list, and data sharing; (2) individual, hospitals working independently; and (3) nonparticipant hospitals. The collaborative and individual arms participated in improvement activities, focusing on reducing hypothermia and invasive ventilatory support. RESULTS: There were 20 collaborative, 31 individual, and 44 nonparticipant hospitals caring for 12 528 eligible infants. Each group had reduced hypothermia from baseline to postintervention. The collaborative group had the most significant decrease in hypothermia, from 39% to 21%, compared with individual hospital efforts of 38% to 33%, and nonparticipants of 42% to 34%. After risk adjustment, the collaborative group had twice the magnitude of decrease in rates of newborns with hypothermia compared with the other groups. Collaborative improvement also led to greater decreases in delivery room intubation (53% to 40%) and surfactant administration (37% to 20%). CONCLUSIONS: Collaborative efforts resulted in larger improvements in delivery room outcomes and processes than individual efforts or nonparticipation. These findings have implications for planning quality improvement projects for implementation of evidence-based practices.

Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk–Based Diet

Abstract Objective: The aim of this study was to compare outcomes of infants pre and post initiation of a feeding protocol providing an exclusive human milk–based diet (HUM). Materials and Methods: In a multicenter retrospective cohort study, infants with a birth weight <1,250 g who received a bovine-based diet (BOV) of mothers own milk fortified with bovine fortifier and/or preterm formula were compared to infants who received a newly introduced HUM feeding protocol. Infants were excluded if they had major congenital anomalies or died in the first 12 hours of life. Data were collected 2–3 years prior to and after introduction of an exclusive HUM diet. Primary outcomes were necrotizing enterocolitis (NEC) and mortality. Secondary outcomes included late-onset sepsis, retinopathy of prematurity (ROP), and bronchopulmonary dysplasia (BPD). Results: A total of 1,587 infants were included from four centers in Texas, Illinois, Florida, and California. There were no differences in baseline demographics or growth of infants. The HUM group had significantly lower incidence of proven NEC (16.7% versus 6.9%, p < 0.00001), mortality (17.2% versus 13.6%, p = 0.04), late-onset sepsis (30.3% versus 19.0%, p < 0.00001), ROP (9% versus 5.2%, p = 0.003), and BPD (56.3% versus 47.7%, p = 0.0015) compared with the BOV group. Conclusions: Extremely premature infants who received an exclusive HUM diet had a significantly lower incidence of NEC and mortality. The HUM group also had a reduction in late-onset sepsis, BPD, and ROP. This multicenter study further emphasizes the many benefits of an exclusive HUM diet, and demonstrates multiple improved outcomes after implementation of such a feeding protocol.

Implementation and Case-Study Results of Potentially Better Practices to Improve Pain Management of Neonates

OBJECTIVE. Collaborative quality improvement techniques were used to facilitate local quality improvement in the management of pain in infants. Several case studies are presented to highlight this process. METHODS. Twelve NICUs in the Neonatal Intensive Care Quality Improvement Collaborative 2002 focused on improving neonatal pain management and sedation practices. These centers developed and implemented evidence-based potentially better practices for pain management and sedation in neonates. The group introduced changes through plan-do-study-act cycles and tracked performance measures throughout the process. RESULTS. Strategies for implementing potentially better practices varied between centers on the basis of local characteristics. Individual centers identified barriers to implementation, developed tools for improvement, and shared their experience with the collaborative. Baseline data from the 12 sites revealed substantial opportunities for improved pain management, and local potentially better practice implementation resulted in measurable improvements in pain management at participating centers. CONCLUSIONS. The use of collaborative quality improvement techniques enhanced local quality improvement efforts and resulted in effective implementation of potentially better practices at participating centers.

Effects of delivery room quality improvement on premature infant outcomes.

Objective:Delivery room management interventions have been successfully implemented via collaborative quality improvement (QI) projects. However, it is unknown whether these successes translate to reductions in neonatal morbidity and mortality.Study Design:This was a prospective pre–post intervention study of three nonrandomized hospital groups within the California Perinatal Quality Care Collaborative. A collaborative QI model (Collaborative QI) was compared with a single-site QI model (NICU QI) and a non-participant population when implementing evidence-based delivery room practices. The intervention period was between June 2011 and May 2012. Infants born with gestational age between 22 weeks 0 days and 29 weeks 6 days and birth weight ⩽1500 g were included. Outcomes were mortality and select morbidities (bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP) and necrotizing enterocolitis (NEC)). Outcomes were compared between the baseline (January 2010 to May 2011) and post-intervention period (June 2012 to May 2013) within each comparison group.Results:Ninety-five hospitals were included with 4222 infants in the baseline period and 4186 infants in the post-intervention period. The Collaborative QI group had significantly reduced odds of developing BPD post-intervention (odds ratio (OR) 0.8, 95% confidence interval (CI) 0.65 to 0.99) or composite BPD-death (OR 0.83, 95% CI 0.69 to 1.00). In both the Collaborative QI and non-participants there were also reductions in IVH, severe IVH, composite severe IVH-death, severe ROP and composite severe ROP-death.Conclusion:Hospitals dedicated to improving delivery room practices can impact neonatal outcomes.

Hospital variation in medical and surgical treatment of patent ductus arteriosus.

OBJECTIVE This study aims to characterize population risks for diagnosis, medical treatment, and surgical ligation of patent ductus arteriosus (PDA) in very low-birth-weight infants. STUDY DESIGN Maternal and neonatal data were collected in 40 hospitals in California during 2011 for infants with birth weight ≤ 1,500 g without any congenital malformation, with a diagnosis of PDA. Multivariable logistic regression was used to determine independent risks for PDA diagnosis and for surgical ligation. RESULTS There were 770/1,902 (40.4%) infants diagnosed with PDA. Low birth weight, gestational age, respiratory distress syndrome, and surfactant administration were associated with PDA diagnosis. Ligation occurred in 43% of patients with birth weight ≤ 750 g, in 24% of patients weighing between 715 and 1,000 g, and in 12% of patients weighing from 1,001 to 1,500 g. Older gestational age (1 week, odds ratio 0.55, 95% confidence interval 0.48-0.63) and absence of respiratory distress syndrome (odds ratio 0.14, 95% confidence interval 0.03-0.59) were associated with lower ligation risk. The median hospital ligation rate was 14% (interquartile range 0-38%). CONCLUSION Most patients with PDA receive treatment for closure. Practice variation may set the stage for further exploration of experimental trials.

Platelet count and associated morbidities in VLBW infants with pharmacologically treated patent ductus arteriosus.

Abstract Objective: Characterize the diagnosis of PDA and the distribution of pretreatment platelet count in pharmacologically managed PDA in infants ≤1500 g and assess the relationship of platelet count to serious morbidities. Study design: This is a retrospective, observational study. In 40 hospitals, data were collected on PDA, including pretreatment platelet count. Distribution of platelet count was examined. The association of platelet count and clinical outcomes of IVH, NEC and PDA closure prior to discharge were examined. Chi-square test was used to compare outcomes by platelet count groups. Results: There were 311 patients treated with medically treated PDA. Pretreatment platelet counts were categorized as 0–119 K, 120–199 K, 200–299 K, >300 K. Incidence and grade of IVH were not significantly different by platelet group. Across all groups: No IVH 62–83%, Grades 1–2 IVH 13–25%, Grades 3–4 IVH 2–13%. NEC occurred in 0–11% of all patients studied. PDA closure rate was 33–45%. Conclusion: PDA closure was not significantly affected by platelet count. Platelet count was not a statistically significant factor for development of IVH and NEC in infants born <1500 g with pharmacologically treated PDA.