Hospitals Case Medical Center Research Articles

Ethical Support for Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT)

From the Case Western Reserve University School of Medicine and the Division of Neonatology, Rainbow Babies and Children’s Hospital/University Hospitals Case Medical Center; and the Rainbow Center for Pediatric Ethics, Rainbow Babies & Children’s Hospital/University Hospitals Case Medical Center, Cleveland, Ohio Randomized Trial (SUPPORT). The randomized study involved 23 major academic centers (including the institution in which I am employed) and was designed to determine the appropriate range of oxygen saturation in extremely preterm infants. This was done by using 2 target ranges of oxygen saturation (low, 85%-89%, and high, 91%-95%). According to Public Citizen’s letter to Department of Health and Human Services Secretary Kathleen Sebelius, the vulnerable infants were subject to “highly unethical” (page 1) and “indefensible” (page 11) research. Parents were deceived into enrolling their infants via “egregious” (page 3) deficiencies in the informed consent process. The letter closes by demanding a “formal apology” (page 11) to all 1316 patients who were enrolled in the study. Public Citizen has grossly distorted what was “known” about treating premature infants at the time of the study. Unfortunately, the use of oxygen in neonatology has a long and tragic history. As early as 1900, oxygen was recommended for premature infants during episodes of cyanosis. Early incubators were flooded with oxygen even though it was recognized that there was no “convincing evidence that an increased oxygen content of arterial blood is beneficial or necessarily of importance.” Additionally, there was no way at this time to quickly and noninvasively measure the baby’s oxygen levels or saturation. By the 1950s, it was recognized that too much oxygen led to blindness in the form of retrolental fibroplasia. Indeed, this was the cause of famous preemie Stevie Wonder’s blindness. After this discovery, oxygen use was restricted and the outcome was disastrous– death and cerebral palsy rates sharply increased. Later calculations estimated that for every infant who kept his sight, 16 infants died. In the following decades, the field of neonatology saw remarkable progress. The discovery of surfactant and widespread adoption of antenatal corticosteroids, better nutrition, gentler ventilators, and care provided by specially

High prevalence of overweight and obesity in females with phenylketonuria

The primary treatment for phenylketonuria (PKU) is a low phenylalanine diet together with an amino acid-based, phenylalanine-free formula. Thus, PKU patients tend to consume a diet enriched in carbohydrates which could predispose to obesity. Studies in the 1980s and 1990s demonstrated that school-age phenylketonuria (PKU) patients have a higher mean body weight compared to a control population. However, no recent studies in the United States PKU population have examined whether this trend has persisted or whether adolescents are also affected. To investigate whether pediatric PKU populations (ages 2–20years) in two major metropolitan areas of the United States (Cleveland, OH and Houston, TX) have a higher than expected percentage of overweight (BMI≥85th percentile) relative to the general population in the United States (NHANES), a retrospective chart review of PKU patients born between 1990 and 2008 and followed in Cleveland, OH (Rainbow Babies and Children's Hospital/University Hospitals Case Medical Center) and in Houston, TX (Texas Children's Hospital) was performed. Based on data from the U.S., 40% of pediatric PKU patients were overweight or obese. However, the percentage of overweight females (55%) and obese females (33%) is 1.8× and 2.1× higher respectively than expected based on comparison data from U.S. children. Further studies are necessary to identify potential strategies for prevention of excessive weight gain in children with PKU, especially in females.

Lack of Financial Barriers to Pediatric Cochlear Implantation

(1) To analyze if socioeconomic status influences access to cochlear implantation in an environment with adequate Medicaid reimbursement. (2) To determine the impact of socioeconomic status on outcomes after unilateral cochlear implantation. Retrospective cohort study. University Hospitals Case Medical Center and Rainbow Babies and Children's Hospital (tertiary referral center), Cleveland, Ohio. Pediatric patients (age range, newborn to 18 years) who received unilateral cochlear implantation during the period 1996 to 2008. Access to cochlear implantation after referral to a cochlear implant center, postoperative complications, compliance with follow-up appointments, and access to sequential bilateral cochlear implantation. A total of 133 pediatric patients were included in this study; 64 were Medicaid-insured patients and 69 were privately insured patients. There was no statistical difference in the odds of initial cochlear implantation, age at referral, or age at implantation between the 2 groups. The odds of prelingual Medicaid-insured patients receiving sequential bilateral cochlear implantation was less than half that of the privately insured group (odds ratio [OR], 0.43; P = .03). The odds of complications in Medicaid-insured children were almost 5-fold greater than the odds for privately insured children (OR, 4.6; P = .03). There were 10 complications in 51 Medicaid-insured patients (19.6%) as opposed to 3 in 61 privately insured patients (4.9%). Medicaid-insured patients missed substantially more follow-up appointments overall (35% vs 23%) and more consecutive visits (1.9 vs 1.1) compared with privately insured patients. In an environment with adequate Medicaid reimbursement, eligible children have equal access to cochlear implantation, regardless of socioeconomic background. However, lower socioeconomic background is associated with higher rates of postoperative complications, worse follow-up compliance, and lower rates of sequential bilateral implantation, observed herein in Medicaid-insured patients. These findings present opportunities for cochlear implant centers to create programs to address such downstream disparities.