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The University of Michigan experience with extracorporeal life support (ECLS) in 1000 consecutive patients between 1980 and 1998 is the largest series at one institution in the world. Among this patient population, survival to hospital discharge in moribund patients with respiratory failure was 88% in 586 neonates, 70% in 132 children, and 56% in 146 adults. Survival in moribund patients with cardiac failure was 48% in 105 children and 33% in 31 adults. This article describes the University of Michigan's overall ECLS patient experience, the progression of ECLS from laboratory experiments to clinical application at the bedside, the expansion of the technology to other centers, and current ECLS technology and outcomes. Despite the challenges faced in clinical research in this field, our experience and that of others has shown that ECLS saves lives of patients with acute cardiac or pulmonary failure in a variety of clinical settings.

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OBJECTIVE: There are little data on the actual care given pediatric tracheostomy patients in their homes. Information on the use of supplies and on techniques and frequency of care is valuable for a better understanding of the needs of this population. DESIGN: Questionnaires were distributed by mail or at clinic visits from May 1995 to June 1996 to a convenience sample of tracheotomized patients at the University of Michigan Pediatric Physical Medicine and Rehabilitation clinic. SETTING: Tertiary care clinic. RESULTS: Clean technique for suctioning was reported by 96.7% of subjects and the rest reported sterile technique. Fifty percent of subjects reported reusing suction catheters. Cleaning solutions used to clean suction catheters for reuse varied. Tracheostomy tube reuse was reported by 55% of subjects. Sixty percent of those who reused tracheostomy tubes had had pneumonia within the previous year, whereas only 25% of those who never reused the tracheostomy tube had pneumonia in the same time period. CONCLUSIONS: Suctioning frequency, suction catheter, and tracheostomy tube reuse and cleaning methods are variables that warrant further investigation of safety and efficacy.

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OBJECTIVE: To determine the effect of bronchopulmonary dysplasia (BPD) on growth at school age. DESIGN: A prospective cohort study. METHODS: The sample included 406 children selected from a reconstructed cohort of infants of very low birth weight previously enrolled in a multisite, randomized, controlled clinical trial. The children were contacted at 8 to 10 years of age. Height, weight, and head circumference (HC) were measured. Possible confounders including sociodemographic data, and neonatal factors were also recorded. RESULTS: The children in the BPD group were significantly smaller in weight (z score, -0.50 +/- 1.19 SD vs -0.06 +/- 1.30 SD) and HC (z score, -1.41 +/- 1.32 SD vs -0.63 +/- 1.62 SD) than those without BPD. However, after controlling for cofounders (using analysis of covariance), no significant differences were demonstrated between the two groups. Power analyses showed that a difference of at least 0.43 z score units could have been detected. The previously documented associations between BPD and suspected confounders were reconfirmed. CONCLUSIONS: Significant differences were noted between children with and without BPD for weight and HC but not height. When possible confounders were taken into account, the differences were no longer appreciated. Thus, the previously reported poor growth in children with BPD may have been related to other factors and not necessarily to BPD.

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Chronic respiratory failure is a major factor contributing to mortality in progressive neuromuscular disorders. Among the muscular dystrophies, respiratory failure most commonly occurs with Duchenne dystrophy, while in Becker, limb-girdle, and facioscapulo-humeral dystrophies, respiratory failure is infrequent and generally occurs in the more severe cases that have progressed to a nonambulatory, advanced functional stage. We report two brothers with a myopathic disease in which the distribution of weakness, initial clinical course, heredity, and muscle pathology most closely resembled a limb-girdle type of dystrophy. Both brothers, however, presented with chronic alveolar hypoventilation and respiratory failure when their locomotor disabilities were still mild. Respiratory failure was reversed, and satisfactory ventilation has been maintained for more than a year using a type of non-invasive intermittent positive pressure ventilation, with a bilevel positive airway pressure device (Bi-PAP), administered through a nasal mask during sleeping hours. These cases demonstrate an unusual presentation of limb-girdle dystrophy, and document that nocturnal, nasal administration of continuous airway pressure using the Bi-PAP device may be sufficient to maintain adequate long-term ventilation in some patients with neuromuscular causes of respiratory failure, and thus significantly improve quality of life and delay the need for more complex or invasive forms of assisted ventilation.

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After it was reported in 1981 that phenobarbital reduced the incidence of intraventricular hemorrhage from 46.7% in control infants to 13.3% in treated premature infants, routine phenobarbital prophylaxis (loading dose, 20 mg/kg; maintenance, 5 mg/kg per day for 5 days) was introduced at the hospital of the original trial for all premature infants with birth weights of < or = 1800 gm. To assess continued efficacy, we reviewed all records of these infants from 1985 through 1989. The overall incidence of intraventricular hemorrhage was 27.5% (168/612); the proportion of severe intraventricular hemorrhage (grade 3 and 4) was 41.1% (69/168). The incidence of intraventricular hemorrhage was lower when loading occurred at < 4 hours: 25.9% (124/478) versus 32.8% (44/134). Outborn infants had a higher incidence of intraventricular hemorrhage than inborn infants (45.3% vs 23.0%). In addition to already known risk factors (gestational age, vaginal delivery, outborn status, pneumothorax, birth asphyxia, patent ductus arteriosus), intraventricular hemorrhage occurred more often in infants with hyperoxia (PO2 > 180 mmHg), hypocarbia (PcO2 > 28 mmHg), hypercarbia (PcO2 > 55 mmHg), and hypotension and hypertension (blood pressure > norm +/- 15 mmHg). These results support the hypothesis that phenobarbital has a role in the prophylaxis against intraventricular hemorrhage. Differences in the efficacy of phenobarbital prophylaxis between various studies may be caused by variations of age at loading and differences in the proportion of very low birth weight infants.(ABSTRACT TRUNCATED AT 250 WORDS)

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Clinicians reserve ECMO for neonates at > 80% predicted mortality risk. The authors hypothesized that ECMO instituted at lower (50%) mortality risk would result in fewer intensive care unit days and a lower hospital cost compared with conventional therapy (including ECMO at high mortality risk). This was a randomized control trial, cost-benefit analysis in an academic newborn intensive care unit. The patients were a prospectively studied, consecutive sample of 41 term neonates with 1) age 24-72 hours, 2) "maximal medical management" for > 6 hours, 3) oxygenation index (OI) values > 25 but < 40. (Severity of illness measured by OI = ((mean airway pressure x FiO2 x 100) PaO2)). All eligible patients entered. Thirty-two of 37 survivors were evaluated at 1 year. Intervention occurred when OI = 25. Patients were randomized to ECMO or continued medical management (ECMO possible at OI = 40). Planned primary outcome measures were ICU days and hospital charges. Secondary measures were pulmonary and neurologic outcomes at discharge and 1 year. Twenty-two early ECMO patients, 19 controls, 14/19 met late ECMO criteria. Four patients died (two each group). No statistically significant difference was seen in hospital charges (early ECMO = $49,500 versus control = $53,7000), (95% confidence intervals = -$3200 to +$5100 more for controls) or ICU days (early = 14 + 5 days versus control = 19 + 12 days) (95% CI = -0.8 to +10 more for controls). At 1 year the early group had a higher mental developmental index score (115 + 11) versus (103 + 18), (p = 0.07).(ABSTRACT TRUNCATED AT 250 WORDS)

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Follow-up studies were conducted to assess the medical and developmental outcome of 92 infants treated with extracorporeal membrane oxygenation at the University of Michigan. Of 118 near-term (greater than 34 weeks' gestation) infants who received extracorporeal membrane oxygenation, 103 (87%) were surviving and available for follow-up at between 1 and 7 years of age. Ninety-two of these children were seen on at least one occasion. Each visit included a history and physical examination, an evaluation by a physical therapist, and developmental testing by a pediatric psychologist. Medical outcome during year 1 found 31% of the children rehospitalized, primarily with respiratory illness. Outpatient-treated lower respiratory tract illness was seen in an additional 31% of the children. New or nonstatic neurologic problems were noted in 6% of the children. Abnormal growth during year 1 occurred in 26% of the children. At last clinic visit 16% of the children exhibited moderate-to-severe neurologic abnormalities, and 8% had moderate-to-severe cognitive delay. Sensorineural hearing loss occurred in 4% of children. Nine percent of the children were receiving speech and language therapy; screening tests showed that an additional 6% had speech and language delay. Overall, at last visit 16 (20%) of the children exhibited some type of handicap. A review of the literature on follow-up studies of non-extracorporeal membrane oxygenation-treated infants with persistent pulmonary artery hypertension produced an impairment rate of 18.5%. Outcome post-extracorporeal membrane oxygenation appears similar to that seen in less ill cohorts of infants treated with more "conventional" therapy. Long-term follow-up of all such infants remains essential.

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For most infants with a disorder of breathing control or airway obstruction, cause and management can be defined with a careful history and a few simple diagnostic tests. Pneumograms and multichannel studies can identify patterns of apnea and associated hypoxemia and can be used to assess therapeutic efficacy. For the majority of infants with disordered breathing, the outcome is favorable and conservative management is appropriate. More extensive diagnostic evaluation is reserved for infants with severe apnea or those with evidence of a significant contributing underlying disease. For these infants, management should be directed at the underlying cause and at identifying and preventing severe, life-threatening events.

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We have applied meta-analysis to investigate the relationship between birth place and the likelihood of neonatal survival, for infants of low birth weight (less than 2501 grams) in a series of 19 non-randomized studies. This paper illustrates the utility meta-analysis in evaluating medical technologies described in non-randomized studies, if proper attention is given to biases in those studies. The results of this meta-analysis show strong preferences for inborn status, especially for infants who weigh 1001-2000 grams. For infants of lower or higher birth weight (that is, less than 1001 or greater than 2000 grams), the studies are inconsistent: some favour inborn status while others favour outborn status. This heterogeneity is not surprising, because selection bias is more problematic in studies of infants at these birth weights. We discuss potential causes of and solutions to selection bias and illustrate its potential magnitude by introducing the bias factor, which should be considered in the design of future studies. When selection bias cannot be ruled out, the results shown for those who weigh 1001-2000 grams are more appropriate for generating valid conclusions and subsequent policies regarding birth place preference for low birth weight infants.

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In retrospective review of survivors of neonatal extracorporeal membrane oxygenation, eight patients with varying degrees of right hemispheric brain injury were identified. The extent of preextracorporeal membrane oxygenation hypoxia and ischemia was documented: five of eight patients had arterial PO2 values of less than 40 mm Hg, seven of eight required dopamine for blood pressure support, and five of eight required cardiopulmonary resuscitation. Two patients had proven neurologic abnormalities before extracorporeal membrane oxygenation. Postextracorporeal membrane oxygenation CT brain scans showed right hemispheric focal abnormalities in three patients. Seven infants had neuromotor abnormalities which were lateralizing in nature; all were left sided, suggesting right-sided brain injury. EEGs showed an increased incidence of slowing and attenuation over the right hemisphere. These findings indicate that right-sided brain abnormalities exist after extracorporeal membrane oxygenation and that carotid artery ligation for extracorporeal membrane oxygenation is not without risk.

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This article reviews the characteristics of 69 clinical research studies of the effectiveness of neonatal intensive care (NIC). Emphasis is on the availability of important information in the studies, and on their scientific quality. The analysis suggests that these studies cannot answer several of the most important questions about the usefulness of NIC, because of poor study design or implementation. Guidelines for assessing the usefulness of existing studies and suggestions for future research are provided.

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Between January 1982 and December 1984, the neonatologists at the University of Michigan Medical Center were asked to render 115 consultations regarding potential medical litigation. Requests for consultation were made by attorneys representing plaintiffs in 36 per cent of cases and defendants in 64 per cent (hospitals, 32 per cent, physicians, 30 per cent, private industry, 2 per cent). A review of these cases indicates frequently recurring themes, especially fetal distress, postdate pregnancies, and birth trauma among obstetrical cases, and neurologic injury, birth asphyxia, meconium aspiration, and hypoglycemia among neonatal cases. In many instances, incomplete documentation in the medical record and poor physician-patient communications were the issues leading to litigation. In 49 per cent of plaintiff cases reviewed, outcomes were felt not be related to the medical care rendered. Sixty-one per cent of defendant cases were felt to be strongly defensible; in 30 per cent of cases significant doubt as to defensibility existed. The physician practicing perinatal or neonatal medicine must be aware of the areas of vulnerability to malpractice litigation and the need for adequate documentation and patient communication. The daily activities of the tertiary neonatologist support his credentials as an expert medical witness in his specialty.

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Intracranial hemorrhage is a complication of extracorporeal membrane oxygenation for the treatment of neonatal respiratory failure. A retrospective review of 35 neonates treated with extracorporeal membrane oxygenation was performed; ten had intracranial hemorrhage. Infants with intracranial hemorrhage had lower birth weights and were gestationally younger than infants with intracranial hemorrhage. Eight of eight neonates of less than 35 weeks' gestational age sustained intracranial hemorrhage. Six died immediately after extracorporeal membrane oxygenation was stopped. Two lived less than 1 year. Two of 27 neonates older than 34 weeks' gestational age sustained intracranial hemorrhage. One child is normal, the other died at 18 months of age. Based on the results of this study, the risk of intracranial hemorrhage appears low in neonates of greater than 34 weeks' gestational age who undergo extracorporeal membrane oxygenation treatment for severe respiratory failure. The use of extracorporeal membrane oxygenation, as it is presently performed, is contraindicated in neonates of less than 35 weeks' gestational age because of the risk of intracranial hemorrhage.

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Extracorporeal membrane oxygenation, using venoarterial or venovenous perfusion, is a safe and effective procedure in the term of near-term infant with life-threatening respiratory failure. Without extracorporeal membrane oxygenation, due to the severity of their disease, these children are at high risk for neurologic damage, chronic lung disease, and death. Because survival is not expected without extracorporeal membrane oxygenation therapy, there is no corresponding control group to which these survivors may be compared. In this report, we reviewed the outcome at 1 to 3 years in the first 14 survivors of extracorporeal membrane oxygenation treated at our institution. Seven of 14 neonatal extracorporeal membrane oxygenation survivors (50%) were normal or near normal at between 1 and 3 years of age. Ten (71%) had normal mental ability. We conclude that in neonates with high mortality risk from respiratory failure, near-normal growth and development can be expected in the majority who survive with extracorporeal membrane oxygenation treatment.

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This study examines the growth and development of 37 preterm infants, 20 with respiratory distress syndrome and 17 with bronchopulmonary dysplasia. The groups were balanced by sex, parity, family configuration, and socioeconomic status and were studied at either 12 or 18 months after hospital discharge. Findings indicate that infants with bronchopulmonary dysplasia are at greater risk for growth retardation in their second year than infants with respiratory distress syndrome. Furthermore, results from cognitive, sensorimotor, and language measures (the Bayley, Uzgiris-Hunt, and Receptive-Expressive Emergent Language scales) demonstrate that infants with bronchopulmonary dysplasia perform significantly less well than infants with respiratory distress syndrome. The group performance of the infants with respiratory distress syndrome suggests that their developmental scores are comparable to those of average, healthy full-term infants of the same age. In contrast, the group of infants with bronchopulmonary dysplasia performed in the low-average to delayed range. Moreover, regression analyses show that type of respiratory illness explains more of the variance in cognitive outcomes than such neonatal factors as birth weight or gestational age. Thus, this study demonstrates that infants with bronchopulmonary dysplasia are at high risk for developmental problems in their second year, and that the contribution of bronchopulmonary dysplasia to explanations of differential cognitive outcomes cannot be reduced to between-group differences in perinatal status.

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A prospective controlled randomized study of the use of extracorporeal membrane oxygenation to treat newborns with respiratory failure was carried out using the "randomized play-the-winner" statistical method. In this method the chance of randomly assigning an infant to one treatment or the other is influenced by the outcome of treatment of each patient in the study. If one treatment is more successful, more patients are randomly assigned to that treatment. A group of 12 infants with birth weight greater than 2 kg met objective criteria for high mortality risk. One patient was randomly assigned to conventional treatment (that patient died); 11 patients were randomly chosen for extracorporeal membrane oxygenation (all survived). Intracerebral hemorrhage occurred in one of 11 surviving children. Extracorporeal membrane oxygenation allows lung rest and improves survival compared to conventional ventilator therapy in newborn infants with severe respiratory failure.

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We have extended our controlled study to a total of 129 patients. Infants treated with phenobarbital confirm to have a significant lower incidence of IVH of all degrees. We now give phenobarbital to all prematures under 1800 g birthweight.

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