Multicenter controlled clinical trial of high-frequency jet ventilation in preterm infants with uncomplicated respiratory distress syndrome.

OBJECTIVE: To test the hypothesis that high-frequency jet ventilation (HFJV) will reduce the incidence and/or severity of bronchopulmonary dysplasia (BPD) and acute airleak in premature infants who, despite surfactant administration, require mechanical ventilation for respiratory distress syndrome. DESIGN: Multicenter, randomized, controlled clinical trial of HFJV and conventional ventilation (CV). Patients were to remain on assigned therapy for 14 days or until extubation, whichever came first. Crossover from CV to HFJV was allowed if bilateral pulmonary interstitial emphysema or bronchopleural fistula developed. Patients could cross over to the other ventilatory mode if failure criteria were met. The optimal lung volume strategy was mandated for HFJV by protocol to provide alveolar recruitment and optimize lung volume and ventilation/perfusion matching, while minimizing pressure amplitude and O2 requirements. CV management was not controlled by protocol. SETTING: Eight tertiary neonatal intensive care units. PATIENTS: Preterm infants with birth weights between 700 and 1500 g and gestational age <36 weeks who required mechanical ventilation with FIO2 >0.30 at 2 to 12 hours after surfactant administration, received surfactant by 8 hours of age, were <20 hours old, and had been ventilated for <12 hours. Outcome Measures. Primary outcome variables were BPD at 28 days and 36 weeks of postconceptional age. Secondary outcome variables were survival, gas exchange, airway pressures, airleak, intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), and other nonpulmonary complications. RESULTS: A total of 130 patients were included in the final analysis; 65 were randomized to HFJV and 65 to CV. The groups were of comparable birth weight, gestational age, severity of illness, postnatal age, and other demographics. The incidence of BPD at 36 weeks of postconceptional age was significantly lower in babies randomized to HFJV compared with CV (20.0% vs 40.4%). The need for home oxygen was also significantly lower in infants receiving HFJV compared with CV (5.5% vs 23.1%). Survival, incidence of BPD at 28 days, retinopathy of prematurity, airleak, pulmonary hemorrhage, grade I-II IVH, and other complications were similar. In retrospect, it was noted that the traditional HFJV strategy emphasizing low airway pressures (HF-LO) rather than the prescribed optimal volume strategy (HF-OPT) was used in 29/65 HFJV infants. This presented a unique opportunity to examine the effects of different HFJV strategies on gas exchange, airway pressures, and outcomes. HF-OPT was defined as increase in positive end-expiratory pressure (PEEP) by >/=1 cm H2O from pre-HFJV baseline and/or use of PEEP of >/=7 cm H2O. Severe neuroimaging abnormalities (PVL and/or grade III-IV IVH) were not different between the CV and HFJV infants. However, there was a significantly lower incidence of severe IVH/PVL in HFJV infants treated with HF-OPT compared with CV and HF-LO. Oxygenation was similar between CV and HFJV groups as a whole, but HF-OPT infants had better oxygenation compared with the other two groups. There were no differences in PaCO2 between CV and HFJV, but the PaCO2 was lower for HF-LO compared with the other two groups. The peak inspiratory pressure and DeltaP (peak inspiratory pressure-PEEP) were lower for HFJV infants compared with CV infants. CONCLUSIONS: HFJV reduces the incidence of BPD at 36 weeks and the need for home oxygen in premature infants with uncomplicated RDS, but does not reduce the risk of acute airleak. There is no increase in adverse outcomes compared with CV. HF-OPT improves oxygenation, decreases exposure to hypocarbia, and reduces the risk of grade III-IV IVH and/or PVL.

Twenty-seven years of experience with oral vitamin K1 therapy in neonates.

Healthy term infants born at the University of Missouri have received vitamin K prophylaxis as a single oral dose since 1967. A retrospective study was undertaken to determine whether either hemorrhagic disease of the newborn or any unexplained intracranial hemorrhage occurred in an infant who received orally administered vitamin K, but none could be found in three separate databases. We conclude that we have met our duty of providing appropriate care.

Intensive care treatment decisions: the roots of our confusion.

BACKGROUND: Decisions to withdraw or withhold treatment from infants and children are continuing concerns. Physicians voice confusion over perceived legal requirements. This confusion may lead to overtreatment of patients. Recent evidence suggests legal concerns still shape physician treatment decisions. OBJECTIVE: This study was undertaken to determine if the legal standard governing these medical decisions was clearly stated. DESIGN: Conventional legal research was performed. Because the 1984 Federal Child Abuse Amendments require these issues to be resolved by state laws, statues of the 50 states and the District of Columbia were reviewed to ascertain if they would support a charge of child abuse for the inappropriate withdrawal of life-support from a child. An electronic legal database was queried for all cases involving withdrawal of life-support in children since 1984; the cases were analyzed to determine if judges were applying the federal legal standard. RESULTS: Current child abuse reporting laws would support the federal standard in all 50 states and the District of Columbia. Six reported withdrawal cases were identified; none applied the federal standard. There is an emerging state legal standard that is flexible and subjective and allows a quality of life analysis because it is based on parental authority. This standard conflicts with the federal standard. CONCLUSIONS: The current law is unclear because two competing legal standards coexist; physicians cannot simultaneously meet both standards. Choosing to apply the state legal standard in clinical medical practice should support families in times of stress and relieve physicians of the burden of considering who is potentially overtreated.

Informed consent in Missouri: where has it taken us?

Between 1987 and 1990 there has been an increase in the number of medical malpractice claims in which lack of informed consent was the sole allegation. This should alert physicians to the need for a better awareness of recent changes in the doctrine of informed consent. Some states have liberalized the scope of the disclosure made to the patient, but Missouri has resisted any further doctrinal expansion in this area. In contrast, changes in the law relating to the doctor/patient relationship are more universally applied and permanent. It is clear that any actual treatment or nontreatment decision remains solely a right of the patient (parent or surrogate). Easily applied guidelines for obtaining informed consent that incorporate these changes are suggested.

Erythrocyte pyruvate kinase deficiency. A case of severe congenital hemolytic anemia.

Although it occurs rarely, erythrocyte pyruvate kinase deficiency is a cause of neonatal jaundice and anemia across many ethnic and geographic groups. In this report of a Missouri case, an infant with this condition was also found to have Pelger-Huet leukocyte anomaly.