bluuebunny/crossref_metadata_2025_split huggingface dataset:
Randomized, Prospective Study of Low-Dose Versus High-Dose Inhaled Nitric Oxide in the Neonate With Hypoxic Respiratory Failure
Authors: Finer Neil N. , Sun Johnny W. , Rich Wade , Knodel Ellen , Barrington Keith J. 
Published: August 2004

Objective.
There is little information on the response to very low doses of inhaled nitric oxide (iNO) in hypoxic near-term infants. The potential toxicities of iNO are dose related; thus, the ability to use lower doses safely and effectively may be advantageous. We hypothesized that there is no difference in the acute improvement in oxygenation between treatment with inhaled nitric oxide at 1 to 2 parts per million (ppm) or 10 to 20 ppm.

Methods.
We randomized near-term and term infants with hypoxic respiratory failure with oxygenation indices (OIs) of ≥10 and Pao2 &lt;100 on 2 separate blood gases taken at least 30 minutes apart. Infants with congenital diaphragmatic hernia were excluded. After parental consent was obtained, patients were randomized to receive a starting nitric oxide (iNO) dose of either 1 to 2 ppm (low-dose group, n = 15) or 10 to 20 ppm (high-dose group, n = 21). The response to iNO was assessed according to the increase in arterial Pao2 and decrease in OI 30 to 60 minutes after exposure to the initial starting concentration. A response of &lt;10% increase on Pao2 and a &lt;10% decrease in OI resulted in a doubling of iNO within the dose range protocol (1, 2, 4, and 8 ppm for the low-dose group; 10, 20, 40, and 80 ppm for the high-dose group).

Results.
Thirty minutes after the study gas was initiated, Pao2 increased significantly overall in the low-dose (90.7 ± 41 torr to 166.8 ± 95.6 torr) and high-dose (76.2 ± 32.7 torr to 198.7 ± 142.8 torr) groups; the maximal increase was seen in the infants who initially were treated with 10 ppm. The OI also decreased significantly overall and also was significant in the high-dose group (21.0 ± 13.7 to 11.4 ± 10.4; low-dose: 18.3 ± 7.1 to 13.2 ± 12.3). There was a nonsignificant fall of Paco2 with iNO treatment (low dose 35 ± 7.3 to 30 ± 8.5 torr vs high dose 35.2 ± 9.9 to 32.4 ± 10.7 torr). A sustained response (ie, maintaining a Pao2 and OI gain greater than 20% for the duration of the study gas administration) was greater in the high-dose group (53.3% vs 30.0%). In addition, dose increases were required more often in the low-dose group than in the high-dose group (80.0% vs 57.1%). Among patients who did not respond to the initial iNO dose, 100.0% and 83.3% responded at higher doses of iNO for the low- and high-dose groups, respectively. There were no differences for death, need for extracorporeal membrane oxygenation, or other outcomes between the groups.

Conclusions.
We did not find any significant difference in response to low- versus high-dose iNO. An initial exposure to low-dose iNO does not compromise the response to higher doses if required and may result in less toxicity.
Onset of Jaundice in Glucose-6-Phosphate Dehydrogenase–Deficient Neonates
Authors: Kaplan Michael , Algur Nurit , Hammerman Cathy 
Published: August 2004

Objective.We asked whether neonatal jaundice associated with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency commences either in utero or in the immediate postnatal period and whether this perinatal bilirubinemia is the precursor of the subsequent neonatal jaundice and hyperbilirubinemia.Methods.Mandatory serum total bilirubin (STB) determinations were performed within 3 hours of birth, to reflect the in utero state (first STB), and on the third day of life (second STB), with additional determinations as clinically necessary, on healthy, term male neonates at high risk for G-6-PD deficiency. G-6-PD Mediterranean mutation was determined by molecular means. G-6-PD–deficient neonates were compared with control participants. The relationship of first STB values to second STB and subsequent hyperbilirubinemia (defined as STB ≥256 μmol/L [15.0 mg/dL]) was determined.Results.Both first and second STB values were significantly higher in the G-6-PD–deficient neonates (n = 52) than in control participants (n = 166; 50 ± 12 μmol/L vs 44 ± 10 μmol/L [2.9 ± 0.7 mg/dL vs 2.6 ± 0.6 mg/dL] and 174 ± 52 μmol/L vs 152 ± 52 μmol/L [10.2 ± 3.1 mg/dL vs 8.9 ± 3.0 mg/dL] for the first and second STB values, respectively). The rate of rise between these 2 points was greater in the G-6-PD–deficient neonates (2.6 ± 0.9 μmol/L/h vs 2.2 ± 0.9 μmol/L/h [0.15 ± 0.05 mg/dL/h vs 0.13 ± 0.05 mg/dL/h). Sixteen (30.8%) of the G-6-PD–deficient neonates developed hyperbilirubinemia compared with 10 (6%) of control participants (relative risk: 5.11; 95% confidence interval: 2.47–10.56). In both G-6-PD–deficient and normal populations, first STB values correlated significantly with both second STB values and with those who subsequently developed hyperbilirubinemia. Significantly more G-6-PD–deficient neonates with a first STB value greater than or equal to the mean developed hyperbilirubinemia compared with those with first STB less than the mean: 13 of 28 neonates versus 3 of 24 (relative risk: 3.7; 95% confidence interval: 1.20–11.51). This difference did not reach statistical significance in the control group.Conclusions.Higher first STB values, an increased risk of hyperbilirubinemia in G-6-PD–deficient neonates with first STB value greater than or equal to the mean, and significant correlation between first STB values and second STB values and hyperbilirubinemia suggest that jaundice in G-6-PD–deficient neonates commences in the immediate perinatal period, most likely in utero.
Haemophilus influenzae Type b Disease Among Amish Children in Pennsylvania: Reasons for Persistent Disease
Authors: Fry Alicia M. , Lurie Perrianne , Gidley Maribeth , Schmink Susanna , Lingappa Jairam , Fischer Marc , Rosenstein Nancy E. 
Published: August 2004

Objective.
To identify reservoirs ofHaemophilus influenzae type b (Hib) pharyngeal carriage and assess barriers to vaccination among 2 Amish communities in Pennsylvania.

Methods.
We investigated recent cases, performed community surveys for Hib vaccination coverage and pharyngeal carriage, and administered a questionnaire assessing vaccination knowledge and attitudes to 298 members of 2 Amish communities (A and B) in Pennsylvania and, as a comparison group, 136 non-Amish family members who participated in state immunization clinics. From December 1999 to February 2000, 8 cases of invasive Hib disease occurred among children who were 5 years of age or younger in Pennsylvania. Six of the case-patients were from Amish communities. None of the children had been vaccinated.

Results.
Among children who were 5 years of age or younger, Hib vaccine coverage was low in the 2 Amish communities: A (9 [28%] of 32) and B (3 [7%] of 41) compared with the non-Amish group (19 [95%] of 20). Hib carriage prevalence was higher in both Amish communities than in the non-Amish group (A: 3%; B: 8%; non-Amish: 0%). More households in community B had 1 or more Hib carriers than in community A (8 [28%] of 29 vs 3 [9%] of 32). Among Amish parents who did not vaccinate their children, only 25% (13 of 51) identified either religious or philosophical objections as a factor; 51% (26 of 51) reported that vaccinating was not a priority compared with other activities of daily life. Seventy-three percent (36 of 49) would vaccinate their children if vaccination were offered locally.

Conclusions.
Undervaccinated communities in the United States still exist and allow circulation of Hib strains, resulting in disease among susceptible children. Identification of undervaccinated populations, such as the Amish, and targeted education and vaccination campaigns are essential to achieving elimination of Hib disease.
Sex Differences in the Secular Changes in Pubertal Maturation
Authors: Papadimitriou Anastasios 
Published: August 2004

Objective.
It is a common experience among pediatricians in the industrialized countries that many girls—but many fewer boys—present with secondary sex characteristics at a younger age than normal. This study examines whether there are sex differences in the secular changes toward earlier pubertal maturation.

Methods.
The author collected the growth data from various studies performed in Greece in the 20th century (from 1928 to 1995) and estimated the age at peak annual height increment in each study by calculating mean increase in height in each successive year.

Results.
In all studies, boys presented peak mean annual height increment at 13 to 14 years of age. Girls did not present a discernible peak height increment until the late 1960s; however, thereafter they presented a peak height increment at 11 to 12 years of age.

Conclusions.
The data suggest sex differences in the secular changes in pubertal maturation, girls being affected more intensely than boys.
Parallel Incidences of Sudden Infant Death Syndrome and Infantile Hypertrophic Pyloric Stenosis: A Common Cause?
Authors: Persson Sofia , Ekbom Anders , Granath Fredrik , Nordenskjöld Agneta 
Published: August 2004

Objective.
To determine whether there was a correlation between the incidence of infantile hypertrophic pyloric stenosis (IHPS) and the incidence of sudden infant death syndrome (SIDS) during the period 1970 to 1997 and to discuss different causative factors that could be influencing the changing trend in incidence.

Methods.
We compared the incidence of IHPS in the Stockholm Health Care Region with the incidence of SIDS in Sweden each year between 1970 and 1997. First, the relation was assessed by calculation of a correlation coefficient; second, the relative linear decrease was estimated for the time period 1990 to 1997.

Results.
The incidence of IHPS increased steadily during the 1970s, from 0.5 per 1000 live births in 1970 to 2.7 in 1979. During the 1980s, the average incidence was 2.8. During the 1990s, there was a significant decrease in the number of IHPS cases in Stockholm. The incidence rate of IHPS parallels the incidence of SIDS during the study period (r = 0.58). The incidence of SIDS dropped after the risk-reduction campaign in the beginning of the 1990s, which recommended that infants sleep on their back. We could not identify any other changes of behavioral risk factors in early exposures that could explain the temporal trends.

Conclusions.
The statistical findings suggest that IHPS and SIDS have causative factors in common. We suggest that prone sleeping is one of those factors.
Antipyretic Efficacy of an Initial 30-mg/kg Loading Dose of Acetaminophen Versus a 15-mg/kg Maintenance Dose
Authors: Tréluyer Jean Marc , Tonnelier Sylvie , d'Athis Philippe , Leclerc Beatrice , Jolivet-Landreau Isabelle , Pons Gérard 
Published: August 2004

Objective.
To compare the antipyretic efficacy of an initial 30-mg/kg acetaminophen loading dose versus a 15-mg/kg maintenance dose.

Methods.
A double-blind, parallel-group, randomized clinical trial was conducted. A total of 121 febrile (rectal temperature between 39°C and 40°C) but otherwise healthy outpatients who were 4 months to 9 years of age and weighed 4 to 26 kg were assigned randomly to 1 of the dose groups: 15 mg/kg (n = 62) and 30 mg/kg (n = 59).

Results.
In an “intention to treat” analysis, the time to obtain a temperature lower than 38.5°C was significantly shorter in the 30-mg/kg than in the 15-mg/kg group (110 ± 94 minutes vs 139 ± 113 minutes). The maximum temperature decrease was significantly higher in the 30-mg/kg than in the 15-mg/kg group (2.3 ± 0.7°C vs 1.7 ± 0.6°C). Duration of rectal temperature below 38.5°C was significantly longer in the 30-mg/kg than in the 15-mg/kg group (250 ± 92 minutes vs 185 ± 121 minutes, respectively). Adverse events were reported in 6 children in the 30-mg/kg group compared with 5 in the 15-mg/kg group (hyperthermia, hypothermia, vomiting). The difference was not statistically significant.

Conclusion.
An initial 30-mg/kg acetaminophen loading dose seemed to be more effective in reducing fever than a 15-mg/kg maintenance dose. No difference was observed regarding clinical tolerance. These data suggest that acetaminophen treatment of fever may be more efficient in an initial loading dose.
Development and Impact of a Computerized Pediatric Antiinfective Decision Support Program
Authors: Mullett Charles J. , Evans R. Scott , Christenson John C. , Dean J. Michael 
Published: August 2004

Objective.Computerized medical decision support tools have been shown to improve the quality of care and have been cited by the Institute of Medicine as one method to reduce pharmaceutical errors. We evaluated the impact of an antiinfective decision support tool in a pediatric intensive care unit (PICU).Methods.We enhanced an existing adult antiinfective management tool by adding and changing medical logic to make it appropriate for pediatric patients. Process and outcomes measures were monitored prospectively during a 6-month control and a 6-month intervention period. Mandatory use of the decision support tool was initiated for all antiinfective orders in a 26-bed PICU during the intervention period. Clinician opinions of the decision support tool were surveyed via questionnaire.Results.The rate of pharmacy interventions for erroneous drug doses declined by 59%. The rate of anti-infective subtherapeutic patient days decreased by 36%, and the rate of excessive-dose days declined by 28%. The number of orders placed per antiinfective course decreased 11.5%, and the robust estimate of the antiinfective costs per patient decreased 9%. The type of anti-infectives ordered and the number of antiinfective doses per patient remained similar, as did the rates of adverse drug events and antibiotic-bacterial susceptibility mismatches. The surveyed clinicians reported that use of the program improved their antiinfective agent choices as well as their awareness of impairments in renal function and reduced the likelihood of adverse drug events.Conclusions.Use of the pediatric antiinfective decision support tool in a PICU was considered beneficial to patient care by the clinicians and reduced the rates of erroneous drug orders, improved therapeutic dosage targets, and was associated with a decreased robust estimate of antiinfective costs per patient. antiinfective agents, decision support systems, drug therapy, medication errors, child, infant.
Changes in Stillbirth and Infant Mortality Associated With Increases in Preterm Birth Among Twins
Authors: Joseph K. S. , Marcoux Sylvie , Ohlsson Arne , Liu Shiliang , Allen Alexander C. , Kramer Michael S. , Wen Shi Wu ,   for the Fetal and Infant Heath Study Group of the Canadian Perinatal Surveillance System
Published: August 2004

Objective.
To examine whether the recent substantial increase in preterm birth among twins has been associated with changes in fetal and infant mortality.

Design.
Cohort study based on information in the linked live birth, stillbirth, and mortality databases of Statistics Canada.

Setting.
Ten of 12 provinces and territories in Canada.

Participants.
All twin live births and stillbirths between 1985 and 1996, along with information on deaths during infancy (1985–1997).

Main Outcome Measure.
Fetal and infant mortality rates.

Results.
The rate of preterm birth among twin live births increased significantly by 17% (95% confidence interval: 14%–20%) from 42.5% between 1985 and 1987 to 49.6% between 1994 and 1996. Overall, stillbirth rates among twins declined from 22.4 per 1000 total births in 1985 to 1987 to 18.8 per 1000 total births in 1994 to 1996. Among twin fetuses ≥34 weeks' gestation, stillbirth rates decreased from 9.5 per 1000 in 1985 to 1987 to 5.4 per 1000 fetuses at risk in 1994 to 1996. Infant mortality rates among twin live births declined substantially in all categories of gestational age above 24 weeks except for live births at 32 to 33 and 34 to 36 weeks' gestation.

Conclusions.
The recent increase in preterm birth among twins was associated with a substantial reduction in stillbirth rates at and near term gestation. Infant mortality rates declined concurrently, although the absence of a significant decrease in infant mortality among twin live births at 32 to 33 and 34 to 36 weeks' gestational age needs additional scrutiny.
Botulinum Toxin Type A Neuromuscular Blockade in the Treatment of Equinus Foot Deformity in Cerebral Palsy: A Multicenter, Open-Label Clinical Trial
Authors: Koman L. Andrew , Brashear Allison , Rosenfeld Samuel , Chambers Henry , Russman Barry , Rang Mercer , Root Leon , Ferrari Eugenio , Garcia de Yebenes Prous J. , Smith Beth P. , Turkel Catherine , Walcott Jennifer M. , Molloy Patricia T. 
Published: August 2004

Background.
Focal spasticity of the gastrocnemius-soleus muscles causes equinus gait in children with cerebral palsy (CP). Botulinum toxin type A (BTX-A), a neuromuscular blocking agent, reduces muscle tone/overactivity in dystonia, stroke, and CP.

Objective.
A prospective, open-label, multicenter clinical trial evaluated the long-term safety and efficacy of repeated intramuscular injections of BTX-A on equinus gait in CP children.

Methods.
Nine centers enrolled 207 children. BTX-A injections (4 U/Kg) were given approximately every 3 months (maximum dose 200 U per treatment). Outcome measures included a Physician Rating Scale of gait, ankle range of motion measurements, and the incidence and profile of adverse events.

Results.
One hundred fifty-five (75%) of 207 children completed at least 1 year with a total of 302 patient years of BTX-A treatment. The mean duration of BTX-A exposure was 1.46 years per patient. Dynamic gait pattern on the Physician Rating Scale improved in 46% of patients (86/185) at first follow-up. The response was maintained in 41% to 58% of patients for 2 years. Both gait pattern and ankle position improved at every visit. The most common treatment-related adverse events included increased stumbling, leg cramps, leg weakness, and calf atrophy in 1% to 11% of patients. No treatment-related serious adverse events were reported. Only 6% (7/117) of patients with pre- and postantibody samples had both detectable antibodies and a subsequent treatment failure.

Conclusion.
BTX-A proved both safe and effective in the chronic management of focal muscle spasticity in children with equinus gait.
Maternal Concern About Positive Test Results in Universal Newborn Hearing Screening
Authors: Weichbold Viktor , Welzl-Mueller Kunigunde 
Published: August 2004

Objective.A positive test result from universal newborn hearing screening (UNHS) has been suspected to cause maternal concern. However, findings so far are inconclusive. Against the background of a 2-stage UNHS protocol, we investigated the extent of maternal concern in 2 different situations: 1) mothers' immediate reactions after a positive result at the first-stage test and 2) maternal concern during a 1-month period while waiting for the infant's hearing assessment after the infant also failed the retest (ie, the screening). In addition, we checked whether mothers who are informed by an audiologist about the low predictive validity of positive test results in hearing screening are less concerned about a positive result than mothers who are not informed.Methods.A prospective study was conducted over a 1-year period, in which all mothers whose infants tested positive in the first stage or failed the screening were questioned about their level of concern attributable to the positive test result.Results.Of 85 mothers whose infants tested positive in the first-stage test (situation 1), 34 (40%) did not know the result. Of the remaining 51 mothers, 59% were not at all concerned and 27% were only slightly concerned about the result, whereas 14% stated that they were highly concerned. In an additional sample of 43 mothers whose infants failed the screening (situation 2), 42% reported not being worried and 37% only slightly worried, whereas 21% were highly concerned about the positive screening result. No effect of information about the low predictive validity of positive test results on the extent of maternal concern could be ascertained.Conclusions.The results of this study contradict the findings of some previous surveys that reported considerably higher levels of maternal concern after a positive test in UNHS. The failure to demonstrate the impact of information on maternal concern might be attributable to the fact that the number of uninformed mothers was too small to affect our results perceptibly.
Establishment of a Clinical Trials Office at a Children's Hospital
Authors: Abzug Mark J. , Esterl Elizabeth A. 
Published: August 2004

Objective.
To create a clinical trials office (CTO) at a children's hospital and assess its impact.

Methods.
Meetings with faculty and clinical trials groups were undertaken to develop a conceptual plan for an exclusively pediatric CTO designed to be a 1-stop office for sponsors, contract research organizations, and investigators. Guiding principles, eg, use of the CTO would be voluntary and paid for on a fee-for-service basis, were defined, and a business plan was developed.

Results.
The CTO opened in October 1997, offering a broad menu of services. Initial marketing efforts have been followed by steadily increasing use of the CTO, measured in a number of studies and investigators who use CTO services. Commensurate growth in CTO staffing has been required. Since the CTO's opening, the number of and revenues from industry-sponsored clinical trials performed at the hospital have been significantly greater than the pre-CTO baseline and have exceeded business plan projections. In addition, the proportion of industry-sponsored clinical research at the hospital that is administered by the CTO has expanded (now &gt;50%). The increase in hospital revenues from industry-sponsored clinical trials has exceeded the cost of running the CTO. Studies performed by the CTO have involved a mix of general pediatric clinic/private office patients, subspecialty clinic patients, and hospitalized children.

Conclusion.
A CTO dedicated to pediatric clinical research can enhance the ability of a children's hospital to participate in the growing number of pediatric clinical trials.