Alarm safety and oxygen saturation targets in the Vermont Oxford Network iNICQ 2015 collaborative.

OBJECTIVES: To assess progress of neonatal intensive care units (NICUs) participating in the Vermont Oxford Network iNICQ 2015: Alarm Safety Collaborative in achieving Joint Commission 2014 alarm safety goals with respect to oximeters, and to compare patient-level oxygen saturation (SpO2) and oximeter alarm data to local policies. STUDY DESIGN: Prospective multicenter audits in February and August 2015 assessed implementation of policies addressing Joint Commission 2014 Alarm Safety goals, and ascertained SpO2 targets, oximeter alarm settings and compliance with policy-specified SpO2 targets and alarms. RESULTS: Eighty-six NICUs completed both audits. Of 13 policies addressing mandated goals, median (interquartile range) 8 (5, 9) policies were implemented at audit 1 and 9 (6, 11) at audit 2 (P=0.004). At audit 1, 28 NICUs had implemented ⩾9 policies versus 47 at audit 2. For 794 infants <31 weeks gestation, <36 weeks postmenstrual age, and on supplemental oxygen, median SpO2 target lower limit was 88% (interquartile range 87%, 90%; range 75% to 94%), upper limit 95% (interquartile range 94%, 96%; range 85% to 100%). High oximeter alarm was set according to local policy for 63% of infants, for whom SpO2 >97% was less frequent than when high alarm was not set to policy (10.1% vs 21.5%, P=0.006). CONCLUSIONS: Participating NICUs showed significant progress between audits in their implementation of Joint Commission Alarm Safety goals for oximeter monitoring. Oximeter high alarm not set per local policy is associated with increased hyperoxemia in preterm infants. Recommendations to standardize oxygen saturation targets for infants at risk for oxygenation-related outcomes have not been widely adopted.

Real time patient safety audits: improving safety every day.

BACKGROUND: Timely error detection including feedback to clinical staff is a prerequisite for focused improvement in patient safety. Real time auditing, the efficacy of which has been repeatedly demonstrated in industry, has not been used previously to evaluate patient safety. Methods successful at improving quality and safety in industry may provide avenues for improvement in patient safety. OBJECTIVE: Pilot study to determine the feasibility and utility of real time safety auditing during routine clinical work in an intensive care unit (ICU). METHODS: A 36 item patient safety checklist was developed via a modified Delphi technique. The checklist focused on errors associated with delays in care, equipment failure, diagnostic studies, information transfer and non-compliance with hospital policy. Safety audits were performed using the checklist during and after morning work rounds thrice weekly during the 5 week study period from January to March 2003. RESULTS: A total of 338 errors were detected; 27 (75%) of the 36 items on the checklist detected >or=1 error. Diverse error types were found including unlabeled medication at the bedside (n = 31), ID band missing or in an inappropriate location (n = 70), inappropriate pulse oximeter alarm setting (n = 22), and delay in communication/information transfer that led to a delay in appropriate care (n = 4). CONCLUSIONS: Real time safety audits performed during routine work can detect a broad range of errors. Significant safety problems were detected promptly, leading to rapid changes in policy and practice. Staff acceptance was facilitated by fostering a blame free "culture of patient safety" involving clinical personnel in detection of remediable gaps in performance, and limiting the burden of data collection.

Major birth defects in very low birth weight infants in the Vermont Oxford Network.

OBJECTIVE: To study the frequency and types of major birth defects in very low birth weight (VLBW) infants and their impact on mortality and resource use. STUDY DESIGN: Analysis of data from the Vermont Oxford Network Database from 1994 and 1995 on infants with birth weights of 501 to 1500 g. Major birth defects were reported from a list of 40 defined major defects or if they were considered lethal or life-threatening. Mortality and length of stay were determined. RESULTS: Major birth defects were present in 823 (4.3%) of 19,228 VLBW infants from 147 hospitals. The most common categories were chromosomal anomalies (20%); named syndromes, sequences, and associations (19%); and gastrointestinal (14%), cardiovascular (11%), and nervous system (10%) anomalies. Infants with major birth defects had a higher mortality rate (58% vs 13%, P <.001) and a higher rate of major surgery (29% vs 5%, P <.001) than infants without such defects. Infants with major birth defects accounted for 16.3% of deaths and 18.9% of major surgical procedures but only for 2.9% of total hospital days. CONCLUSIONS: Major birth defects accounted for 16% of all deaths in VLBW infants. However, they accounted for a low proportion of total hospital days.

Collaborative quality improvement for neonatal intensive care. NIC/Q Project Investigators of the Vermont Oxford Network.

OBJECTIVE: To make measurable improvements in the quality and cost of neonatal intensive care using a multidisciplinary collaborative quality improvement model. DESIGN: Interventional study. Patient demographic and clinical information for infants with birth weight 501 to 1500 g was collected using the Vermont Oxford Network Database for January 1, 1994 to December 31, 1997. SETTING: Ten self-selected neonatal intensive care units (NICUs) received the intervention. They formed 2 subgroups (6 NICUs working on infection, 4 NICUs working on chronic lung disease). Sixty-six other NICUs served as a contemporaneous comparison group. PATIENTS: Infants with birth weight 501 to 1500 g born at or admitted within 28 days of birth between 1994 and 1997 to the 6 study NICUs in the infection group (n = 3063) and the 66 comparison NICUs (n = 21 509); infants with birth weight 501 to 1000 g at the 4 study NICUs in the chronic lung disease group (n = 738). INTERVENTIONS: NICUs formed multidisciplinary teams that worked together under the direction of a trained facilitator over a 3-year period beginning in January 1995. They received instruction in quality improvement, reviewed performance data, identified common improvement goals, and implemented "potentially better practices" developed through analysis of the processes of care, literature review, and site visits. MAIN OUTCOME MEASURES: The rates of infection after the third day of life with coagulase-negative staphylococcal or other bacterial pathogens for infants with birth weight 501 to 1500 g, and the rates of oxygen supplementation or death at 36 weeks' adjusted gestational age for infants with birth weight 501 to 1000 g. RESULTS: Between 1994 and 1996, the rate of infection with coagulase-negative staphylococcus decreased from 22.0% to 16.6% at the 6 project NICUs in the infection group; the rate of supplemental oxygen at 36 weeks' adjusted gestational age decreased from 43.5% to 31.5% at the 4 NICUs in the chronic lung disease group. There was heterogeneity in the effects among the NICUs in both project groups. The changes observed at the project NICUs for these outcomes were significantly larger than those observed at the 66 comparison NICUs over the 4-year period from 1994 to 1997. CONCLUSION: We conclude that multidisciplinary collaborative quality improvement has the potential to improve the outcomes of neonatal intensive care.

Economic implications of neonatal intensive care unit collaborative quality improvement.

OBJECTIVE: To make measurable improvements in the quality and cost of neonatal intensive care using a multidisciplinary collaborative quality improvement model. DESIGN: Interventional study. Data on treatment costs were collected for infants with birth weight 501 to 1500 g for the period of January 1, 1994 to December 31, 1997. Data on resources expended by hospitals to conduct this project were collected in a survey for the period January 1, 1995 to December 31, 1996. SETTING: Ten self-selected neonatal intensive care units (NICUs) received the intervention. They formed 2 subgroups (6 NICUs working on infection, 4 NICUs working on chronic lung disease). Nine other NICUs served as a contemporaneous comparison group. PATIENTS: Infants with birth weight 501 to 1500 g born at or admitted within 28 days of birth between 1994 and 1997 to the 6 study NICUs in the infection group (N = 2993) and the 9 comparison NICUs (N = 2203); infants with birth weight 501 to 1000 g at the 4 study NICUs in the chronic lung disease group (N = 663) and the 9 comparison NICUs (N = 1007). INTERVENTIONS: NICUs formed multidisciplinary teams which worked together to undertake a collaborative quality improvement effort between January 1995 and December 1996. They received instruction in quality improvement, reviewed performance data, identified common improvement goals, and implemented "potentially better practices" developed through analysis of the processes of care, literature review, and site visits. MAIN OUTCOME MEASURES: Treatment cost per infant is the primary economic outcome measure. In addition, the resources spent by hospitals in undertaking the collaborative quality improvement effort were determined. RESULTS: Between 1994 and 1996, the median treatment cost per infant with birth weight 501 to 1500 g at the 6 project NICUs in the infection group decreased from $57 606 to $46 674 (a statistical decline); at the 4 chronic lung disease hospitals, for infants with birth weights 501 to 1000 g, it decreased from $85 959 to $77 250. Treatment costs at hospitals in the control group rose over the same period. There was heterogeneity in the effects among the NICUs in both project groups. Cost savings were maintained in the year following the intervention. On average, hospitals spent $68 206 in resources to undertake the collaborative quality improvement effort between 1995 and 1996. Two thirds of these costs were incurred in the first year, with the remaining third in the second year. The average savings per hospital in patient care costs for very low birth weight infants in the infection group was $2.3 million in the post-intervention year (1996). There was considerable heterogeneity in the cost savings across hospitals associated with participation in the collaborative quality improvement project. CONCLUSION: Cost savings may be achieved as a result of collaborative quality improvement efforts and when they occur, they appear to be sustainable, at least in the short run. In high-cost patient populations, such as infants with very low birth weights, cost savings can quickly offset institutional expenditures for quality improvement efforts.

Morbidity and mortality among very-low-birth-weight neonates with intrauterine growth restriction. The Vermont Oxford Network.

OBJECTIVE: We sought to determine the associations between intrauterine growth restriction and neonatal morbidity and mortality, as well as the impact of prenatal glucocorticoid administration on the frequency of specific complications of prematurity among neonates with intrauterine growth restriction. STUDY DESIGN: We examined the association between intrauterine growth restriction and adverse neonatal outcomes in a population of 19,759 singleton very-low-birth-weight neonates without major birth defects. We included neonates from 25 to 30 weeks' gestation entered in the Vermont Oxford Network database between 1991 and 1996 by 196 institutions. Intrauterine growth restriction was defined as the 10th percentile for birth weight according to the 1993 US national statistics. Odds ratios were estimated according to stepwise logistic regression for each neonatal outcome. Potential explanatory variables included gestational age, intrauterine growth restriction, race, prenatal care, prenatal glucocorticoid administration, route of delivery, fetal sex, and birth within versus postnatal transfer to a network institution. RESULTS: There was a statistically significant association of intrauterine growth restriction with neonatal death (odds ratio, 2.77; 95% confidence interval, 2.31-3. 33), necrotizing enterocolitis (odds ratio, 1.27; 95% confidence interval, 1.05-1.53), and respiratory distress syndrome (odds ratio, 1.19; 95% confidence interval, 1.03-1.36). There was a trend (P <. 10) toward association of intrauterine growth restriction with increased risks of intraventricular hemorrhage (odds ratio, 1.13; 95% confidence interval, 0.99-1.29) and severe intraventricular hemorrhage (grades III and IV; odds ratio, 1.25; 95% confidence interval, 0.98-1.59). Maternal prenatal glucocorticoid administration was associated with significantly lower risks of respiratory distress syndrome (odds ratio, 0.51; 95% confidence interval, 0.44-0.58), intraventricular hemorrhage (odds ratio, 0.67; 95% confidence interval, 0.61-0.73), severe intraventricular hemorrhage (odds ratio, 0.50; 95% confidence interval, 0.43-0.57), and death (odds ratio, 0.54; 95% confidence interval, 0.48-0.62). The benefits of prenatal glucocorticoid therapy for growth-restricted newborns were similar to those among normally grown infants. CONCLUSIONS: Intrauterine growth restriction within the range of 501 to 1500 g birth weight is associated with increased risks of neonatal death, necrotizing enterocolitis, and respiratory distress syndrome. Prenatal corticosteroid use was associated with decreased risks of all outcomes studied except necrotizing enterocolitis. We found no evidence that this benefit was dependent on fetal size.

Cardiopulmonary resuscitation in the very low birth weight infant: the Vermont Oxford Network experience.

OBJECTIVE: The limited literature available to date suggests that the use of delivery room cardiopulmonary resuscitation (DR-CPR) is associated with very poor outcomes, especially for extremely low birth weight infants. We reviewed the cumulative experience of the Vermont Oxford Network to determine the actual utilization of DR-CPR and the neonatal outcomes of such infants. METHODS: A retrospective review of information available in the Vermont Oxford Network Database for the years 1994 to 1996. The data set was collected from 196 neonatal units who participate in the Network (data for infants 401 to 500 g were from 1996 only). Infants were eligible for study if they received DR-CPR defined as the administration of chest compressions and/or epinephrine in the delivery room as noted on the Vermont Oxford Network Database record. RESULTS: Information regarding survival was available for 27 707 newborns with birth weights from 501 to 1500 g, and 497 infants with birth weights from 401 to 500 g. There were 24 001 (86.6%) survivors. Overall DR-CPR was given to 9.3% of infants from 401 to 500 g and 6% of infants from 501 to 1500 g, 82.1% receiving chest compressions, and 66.7% receiving epinephrine. Survival of infants receiving DR-CPR was 23. 9% for infants of 401 to 500 g, and 63.3% for infants of 501 to 1500 g, compared with 16.7% and 87.9% for infants in these weight groups not receiving DR-CPR. Survival was greater for infants of 501 g or greater without DR-CPR compared with those who received this intervention within each 250-g birth weight subgroup. For infants of <1000 g, survival was 53.8% with DR-CPR compared with 74.9% without. Head ultrasounds were available for 95.5% of all surviving infants and 96.7% of infants who received DR-CPR. Overall, any grade of intraventricular hemorrhage (IVH) occurred more frequently in infants who received DR-CPR (38%) than in those who did not (21%). Grade 3 or 4 (severe) IVH was seen in 15.3% of infants who received DR-CPR compared with 4.9% of the infants who did not. Overall, survival without severe IVH occurred in 52.2% of DR-CPR infants compared with 81.3% of infants who did not require this intervention. CONCLUSION: The majority of very low birth weight and extremely low birth weight infants who receive DR-CPR survive, and at least half of such infants who survive do not have evidence of severe IVH. Further follow-up studies are required to determine the long-term neurodevelopmental outcome of such infants. The current study does not support the previously noted poor outcome in extremely low birth weight infants who receive DR-CPR.

The Vermont Oxford Network: evidence-based quality improvement for neonatology.

The Vermont Oxford Network is a voluntary collaborative group of health professionals committed to improving the effectiveness and efficiency of medical care for newborn infants and their families through a coordinated program of research, education, and quality-improvement projects. In support of these activities, the Network maintains a clinical database of information about very low birth weight infants that now has more than 300 participating neonatal intensive care units (NICUs). We anticipate that these NICUs will submit data for 25 000 infants with birth weights of 401 to 1500 g born in 1998. The research program of the Network includes outcomes research and randomized clinical trials. The goal of Network outcomes research is to identify and explain the variations in clinical practice and patient outcomes that are apparent among NICUs. Network trials are designed to answer practical questions of importance to practitioners and families using pragmatic designs that can be integrated into the daily practice of neonatology. Quality improvement is a major focus of the Network. Members receive confidential quarterly and annual reports based on the Network database that document their performance and compare practices and outcomes at their unit with those at other units within the Network. These reports are intended to assist the members in identifying opportunities for improvement and to help them monitor the success of their improvement efforts. Although information is necessary for improvement to occur, it is not sufficient to foster lasting improvement by itself. Information must be translated into action. The Network is sponsoring an ongoing program of quality initiatives designed to provide members with the knowledge, skills, tools, and resources needed to foster action for improvement. The Network's first formal quality-improvement project, the NIC/Q Project, brought together 10 NICUs to apply the methods of collaborative improvement and benchmarking to neonatal intensive care. Building on the lessons learned in that initial project, the Network now is conducting the Vermont Oxford Network Evidence-Based Quality Improvement Collaborative for Neonatology, known as NIC/Q 2000. This 2-year collaborative will assist multidisciplinary teams from the 34 participating NICUs to develop four key habits for improvement: the habit for change, the habit for practice as a process, the habit for collaborative learning, and the habit for evidence-based practice. During the collaborative, participants will contribute to a knowledge bank of clinical, organizational, and operational change ideas for improving neonatal care. The coordinated program of research, education, and quality improvement described in this article is only possible because of the voluntary efforts of the members. The Network will continue to support these efforts by developing and providing improved tools and resources for the practice of evidence-based neonatology.neonatology, very low birth weight, database, network, quality improvement, evidence-based medicine, randomization, trials, outcomes, mortality, length of stay.

Increasing use of antenatal corticosteroid therapy between 1990 and 1993 in Vermont Oxford Network.

OBJECTIVE: The purpose of this study was to determine whether the frequency of antenatal corticosteroid treatment changed between 1990 and 1993 and to identify patient characteristics associated with the use of this treatment. STUDY DESIGN: A total of 17,335 infants born in the years 1990 to 1993 with birth weights of 1500 gm or less and gestational ages of 24 to 34 weeks who were cared for at one of the 94 institutions participating in the Vermont Oxford Network were included in the study. Ninety-one infants were excluded from analysis because of missing data, resulting in a final sample of 17,244 infants. RESULTS: The percentage of infants whose mothers received antenatal corticosteroid treatment increased steadily during the 4-year study period (19.3% in 1990, 24.8% in 1991, 28.6% in 1992, and 34.1% in 1993; p < 0.001 by chi square test for trend in proportions). The results of a logistic regression analysis indicated that increasing year of birth, inborn location of birth, prenatal care, and multiple birth were associated with an increased use of antenatal corticosteroid treatment; black race and small size for gestational age were associated with decreased use of the treatment. In 1993, the median percentage of infants at an individual institution whose mothers received antenatal corticosteroid treatment was 25%; 10% of institutions had percentages less than 7% and 10% had percentages higher than 60%. CONCLUSION: Although the use of antenatal corticosteroid treatment increased steadily during the study period, this treatment was still used infrequently at many institutions in 1993. Considerable improvements in outcomes for preterm infants can be achieved if the recommendations of the National Institutes of Health Consensus Development Panel regarding more widespread use of antenatal corticosteroid treatment are adopted by health professionals who provide medical care to pregnant women.

Hospital and patient characteristics associated with variation in 28-day mortality rates for very low birth weight infants. Vermont Oxford Network.

BACKGROUND: The outcomes for very low birth weight infants vary among neonatal intensive care units (NICUs), but the reasons for this variation are not well understood. We used the database of a large neonatology research network to determine whether either admission characteristics of the infants or specific characteristics of the units such as annual patient volume and the presence of a pediatric residency program could account for observed differences in neonatal mortality rates among units. METHODS: We studied 7672 infants with birth weights from 501 to 1500 g treated during 1991 and 1992 at 62 NICUs participating in the Vermont Oxford Network Database. RESULTS: Overall, 14.7% of the study infants died within 28 days of birth (interquartile range 9.9% to 18.1%). The ratio of the number of observed deaths at an NICU to the number of deaths predicted based on the characteristics of infants treated at the NICU (standardized neonatal mortality ratio, [SNMR]) varied significantly among units (range 0 to 1.69, z = 4.24). There was no association between annual patient volume and either mortality rate (r = .17) or SNMR (r = .22). Observed mortality rates (17% vs 13%) and SNMR (1.04 vs .87) were both higher at the 24 hospitals with pediatric residency training programs than at the 38 hospitals without such programs. Hospitals with residency programs had higher average annual patient volumes (104 vs 66). In an analysis simultaneously adjusting for patient characteristics, volume, and presence of a residency program, neither volume (odds ratio [OR] per 10 additional cases treated 1.01, 95% confidence interval [CI], .98 to 1.04) nor presence of a pediatric residency program (OR 1.18, 95% CI, .94 to 1.47) was significantly associated with neonatal mortality risk. CONCLUSION: There are differences in neonatal mortality rates among NICUs that cannot be explained by differences in the measured admission characteristics of the infants, suggesting that the effectiveness of medical care varies among units. Neither the annual volume of very low birth weight infants treated in a unit nor the presence of a pediatric residency training program was independently associated with neonatal mortality rates for very low birth weight infants.

Very-low-birth-weight outcomes of the National Institute of Child Health and Human Development Neonatal Network, November 1989 to October 1990.

OBJECTIVE: Our purpose was to describe the neonatal outcomes of 1804 very-low-birth-weight (< or = 1500 gm) infants delivered between November 1989 and October 1990 in the participating centers of the National Institute of Child Health and Human Development Neonatal Research Network. STUDY DESIGN: In an observational study sociodemographic, pregnancy, and delivery data were collected soon after birth, and neonatal and outcome data at discharge, at 120 days, or at death. RESULTS: Maternal and birth weight characteristics included 64% black, 29% white; 71% single mothers; 18% no prenatal care; 17% antenatal steroids; and 12% multiple gestations. Birth weight distributions included 18% weighing 501 to 750 gm, 23% 751 to 1000 gm, 28% 1001 to 1250 gm, and 31% 1251 to 1500 gm. Survival was 39% at < 751 gm birth weight, 77% at 751 to 1000 gm, 90% at 1001 to 1250 gm, and 93% at 1251 to 1500 gm. Survival was 15% to 18% at < or = 23 weeks' gestation, 54% at 24 weeks, 59% at 25 weeks, and 71% at 26 weeks. Surfactant was administered to 45% of the 56% of infants with respiratory distress syndrome. Morbidity, including intraventricular hemorrhage (40%), septicemia (24%), symptomatic patent ductus arteriosus (22%), and necrotizing entercolitis (8%), increased with decreasing birth weight. Oxygen was administered for > or = 28 days to 82% of < 751 gm infants, 49% of 751 to 1000 gm infants, and 10% of > 1001 gm infants. Steroids were administered to 28% of infants who required oxygen for > or = 28 days. Mean hospital stay was 62 days for survivors and 18 days for infants who died. There were large intercenter variations in mortality and morbidity. CONCLUSION: Mortality and morbidity in very-low-birth-weight infants improved in 1989 to 1990 without an increase in morbidity or length of hospital stay. The threshold of the improved survival was > or = 24 weeks and 601 to 700 gm. Although such data are reassuring, the rate of major morbidity in < 1001 gm birth weight infants continues to be high.

An assessment of data quality in the Vermont-Oxford Trials Network database.

The Vermont-Oxford Trials Network is a voluntary collaborative research group of neonatologists that maintains a database for very low birthweight infants (501-1500 g). The database (1) provides core data for randomized trials, (2) serves as a resource for outcomes research in neonatology, and (3) generates quality management reports for participating sites. To assess the reliability of this database and to determine the sources of error, we reviewed 635 medical records chosen at random from among the 4341 eligible infants born at 40 participating data generating sites during an 18-month period beginning January 1, 1990. The estimated frequencies of disagreement between the medical record and database for each of the 10 data items studied and the standard errors of the estimates (in parentheses) were: date of birth 1.3% (0.4), date of admission 2.5% (0.6), date of discharge 8.8% (1.0), birthweight (difference > 50 g) 2.9% (0.6), location of birth (inborn or outborn) 2.1% (0.5), multiple birth 2.2% (0.5), cesarean section 2.5% (0.6), gender 2.1% (0.5), status 28 days after birth 3.4% (0.6), final status 2.9% (0.6). The overall proportions and mean values for items in the database were close to the estimated values based on the random sample of records. There were a total of 247 disagreements between the database and the medical records in the sample. Twenty-three were due to data keying errors. Two hundred twenty-four were due to errors in transcription or interpretation. The rate of data keying errors decreased from over 50 errors per 10,000 fields to less than 15 errors per 10,000 fields when specific quality control procedures, including visual inspection, were instituted. Data keying errors accounted for 13.7% of all disagreements between the database and medical record before improved data entry methods were introduced, and only 3.7% of all errors after they were introduced. We concluded that the Vermont-Oxford Trials Network Database is reliable. Data keying errors have been reduced by the introduction of additional quality control measures. Further reductions in database errors will require measures aimed at minimizing transcription or interpretation errors by individuals completing the data forms.

Evaluation of neonatal intensive care technologies.

The development and dissemination of neonatal intensive care technology has been associated with improved survival for critically ill newborn infants, particularly those with birth weights of less than 1,500 grams (3 pounds, 5 ounces). Despite these advances, there are concerns about the long-term health status of surviving infants and the costs of their initial and subsequent care. In this article, the authors review current evidence for the effectiveness of neonatal intensive care and discuss several approaches to evaluating neonatal intensive care technology. They discuss a four-step process originally proposed by Roper for assessing and improving neonatal intensive care practices which includes (1) monitoring of practices, outcomes, and costs; (2) analysis of variation in practices, outcomes, and costs; (3) assessment of the efficacy of individual interventions, and (4) feedback and education to alter clinical behavior. The authors conclude that organized networks of neonatal intensive care units can play a crucial role in this process.

A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome. National Institute of Child Health and Human Development Neonatal Research Network.

OBJECTIVE: To compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome. DESIGN: Multicenter randomized trial. SETTING: Eleven tertiary care university neonatal intensive care units participating in the National Institute of Child Health and Human Development Neonatal Research Network. PATIENTS: Newborn infants (n = 617) weighing 501 to 1500 gm with respiratory distress syndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and January 1992. INTERVENTIONS: Infants were randomly assigned to receive up to four intratracheal doses of either Exosurf Neonatal (n = 309) or Survanta (n = 308). MAIN OUTCOME MEASURES: The occurrence of death or bronchopulmonary dysplasia 28 days after birth and the average fraction of inspired oxygen (FIO2) and mean airway pressure (MAP) during the first 72 hours after treatment. RESULTS: Death or bronchopulmonary dysplasia occurred in 67% of the infants in the Exosurf group and 62% of those in the Survanta group (adjusted relative risk, 1.07; 95% confidence interval, 0.96 to 1.20). During the 72 hours after the first surfactant dose, the average FIO2 (+/- SEM) was 0.50 +/- 0.01 for Exosurf and 0.42 +/- 0.01 for Survanta (difference, 0.08; 95% confidence interval, 0.05 to 0.11); the average MAP (+/- SEM) was 7.64 +/- 0.21 cm H2O for Exosurf and 6.93 +/- 0.21 cm H2O for Survanta (difference, 0.71 cm H2O; 95% confidence interval, 0.13 to 1.29 cm H2O). There was no difference between the groups in the incidence of other neonatal morbidities or in the duration of hospitalization, assisted ventilation, or supplemental oxygen administration. CONCLUSION: We found no difference between treatment groups in the incidence of death or bronchopulmonary dysplasia, although we did observe a difference in the initial response to treatment as measured by FIO2 and MAP.

Decreasing mortality associated with the introduction of surfactant therapy: an observational study of neonates weighing 601 to 1300 grams at birth. The Members of the National Institute of Child Health and Human Development Neonatal Research Network.

OBJECTIVE: To determine whether the introduction of surfactant therapy was associated with decreased mortality for high-risk preterm neonates weighing 601 to 1300 g at birth. DESIGN: Before-after observational study. SETTING: Eight tertiary care neonatal intensive care units participating in the National Institute of Child Health and Human Development Neonatal Research Network. PATIENTS: The outcomes for neonates with birth weight 601 to 1300 g admitted in the 2 years before surfactants became available (n = 2780) were compared with those of neonates admitted in the year beginning 2 months after surfactants became available (n = 1413). MAIN OUTCOME MEASURES: The primary outcome measure was in-hospital mortality; secondary outcome measures included durations of assisted ventilation, length of hospitalization, and neonatal morbidity. RESULTS: Forty percent of neonates in the postsurfactant group received surfactant (range 28% to 69% at the centers). Mortality decreased from 27.8% before to 19.9% after surfactant therapy was introduced (Mantel-Haenszel chi 2 = 31.4, P = .001). The adjusted odds ratio for mortality after surfactants became available was 0.73 (95% confidence interval 0.55 to 0.95). The duration of assisted ventilation and length of hospitalization increased after surfactants were introduced (P = .0001 for both outcomes). CONCLUSION: Mortality for neonates weighing 601 to 1300 g decreased after surfactant therapy was introduced, suggesting that the efficacy of surfactants demonstrated in randomized controlled trials will translate into effectiveness in routine clinical care.