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  • 1
    Online Resource
    Online Resource
    Off-Label Use of Medical Devices in Children
    American Academy of Pediatrics (AAP) ; 2017
    In:  Pediatrics Vol. 139, No. 1 ( 2017-01-01)
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 139, No. 1 ( 2017-01-01)
    Abstract: Despite widespread therapeutic needs, the majority of medical and surgical devices used in children do not have approval or clearance from the Food and Drug Administration (FDA) for use in pediatric populations. The clinical need for devices to diagnose and treat diseases or conditions occurring in children has led to the widespread and necessary practice in pediatric medicine and surgery of using approved devices for “off-label” or “physician-directed” applications that are not included in FDA-approved labeling. This practice is common and often appropriate, even with the highest-risk (class III) devices. The legal and regulatory framework used by the FDA for devices is complex, and economic or market barriers to medical and surgical device development for children are significant. Given the need for pediatric medical and surgical devices and the challenges to pediatric device development, off-label use is a necessary and appropriate part of care. In addition, because of the relatively uncommon nature of pediatric conditions, FDA clearance or approval often requires other regulatory pathways (eg, Humanitarian Device Exemption), which can cause confusion among pediatricians and payers about whether a specific use, even of an approved device, is considered experimental. This policy statement describes the appropriateness of off-label use of devices in children; the use of devices approved or cleared through the FDA regulatory processes, including through the Humanitarian Device Exemption; and the important need to increase pediatric device labeling information for all devices and especially those that pose the highest risk to children.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    URL: Article
    DOI: 10.1542/peds.2016-3439
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2017
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  • 2
    Online Resource
    Online Resource
    Excretory Urography for Evaluation of Enuresis
    American Academy of Pediatrics (AAP) ; 1980
    In:  Pediatrics Vol. 65, No. 1 ( 1980-01-01), p. A49-A50
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 65, No. 1 ( 1980-01-01), p. A49-A50
    Abstract: Enuresis is the involuntary discharge of urine occurring beyond the age when control of the urinary bladder should have been acquired.1 Eighty percent of children with enuresis have problems staying dry at night, 5% in the day, and 15% both day and night.2 The age at which children can be expected to stay dry at night is not well established and is often cause for extreme concern for parents and children alike. Most children are still not dry at night by age 2 years. In a study of 315 children, Klackenberg reported 87% dry by 3 years and 96% dry by 6 years. Essen and Peckham,4 reviewing the records of 12,000 children, found enuresis more prevalent in older ages. More than 10% of their patients were enuretic between ages 5 and 7 years and almost 5% were still having problems at 11 years of age. The etiology of enuresis is also difficult to define, and many different theories have been advanced. Bindelglas5 grouped these into five major categories: (1) organo-urogenic, including urologic malformations; (2) psychogenic; (3) developmental; (4) genetic; (5) environmental. The first of these categories must be of primary concern to the physician when confronted with an enuretic child, ie, could the symptoms possibly reflect a surgically correctable urologic abnormality? Radiologic procedures such as excretory urography and mictunition cystourethrography are the studies usually relied on to exclude an underlying anatomic lesion. Because of the potential risk and expense of any radiologic procedure as well as the possible low yield in this condition, the Committee on Radiology examined the utility of these studies in the routine evaluation of enuresis.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    URL: Article
    DOI: 10.1542/peds.65.1.A49
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 1980
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  • 3
    Online Resource
    Online Resource
    FAMILY LIFE AND SEX EDUCATION
    American Academy of Pediatrics (AAP) ; 1968
    In:  Pediatrics Vol. 42, No. 3 ( 1968-09-01), p. 535-537
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 42, No. 3 ( 1968-09-01), p. 535-537
    Abstract: The American Academy of Pediatrics is deeply concerned with the increasing social health problems in today's society, particularly those that relate to the function of the family as a unit and to the behavior of its children and youth. Some of the signs of the serious social, moral, and ethical crisis facing us are: increasing illegitimacy, early marriage, dangerous drug use, rising incidence of venereal disease, family fragmentation manifested in divorce, and lack of restraint within the mass media in presenting sexually stimulating material to young and immature persons. It is the Academy's conviction that all segments of the society of responsible adults, lay and professional, must mobilize now in support of personal and collective action to help children and adolescents grow to a healthy maturity as intellectually, socially, and sexually secure individuals. We join with other national organizations, such as the National Congress of Parents and Teachers, the American Medical Association, the National Education Association, and support the interfaith statement of the nation's major religions in officially supporting health education, including family life and sex education. We urge programs that will create a vigorous and healthy social climate in which family life can flourish and which foster mature sexual behavior in each individual. With this larger goal in mind, we propose and endorse the following general programs and actions. 1. Every concerned adult, lay or professional, must be encouraged to examine his own values and behaviors in order to develop an openness which permits a meaningful rapport with children and youth.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    URL: Article
    DOI: 10.1542/peds.42.3.535
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 1968
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  • 4
    Online Resource
    Online Resource
    Comparison Radiographs of Extremities in Childhood: Recommended Usage
    American Academy of Pediatrics (AAP) ; 1980
    In:  Pediatrics Vol. 65, No. 1 ( 1980-01-01), p. A57-A58
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 65, No. 1 ( 1980-01-01), p. A57-A58
    Abstract: Extremity injuries, a common problem in pediatric practice, are responsible for a significant number of radiographic examinations performed on children each year. Radiologic diagnosis in these injuries may be complicated by the variable appearance of the growing skeleton, especially around the epiphyses and the physeal plate. In the past, it has been a common and accepted practice for pediatricians, generalists, orthopedic surgeons, and radiologists to obtain routinely radiographs of the uninjured limb1-3 for comparison with those of the injured extremity to rule out subtle fractures or dislocations. Recently, increasing concern about potential dangers of ionizing radiation, coupled with agitation from insurance carriers and governmental agencies to reduce escalating medical costs, has resulted in mounting pressure to limit diagnostic radiographic examinations. At the same time, however, rising malpractice litigation has, in many instances, forced physicians to obtain additional radiographic studies to "protect" themselves, especially in trauma cases. Radiographs of traumatized extremities contribute significant numbers of medicolegally oriented radiologic examinations each year. Although comparison views are no doubt helpful in some instances, until recently there has not been any effort to document the extent of use or diagnostic value of comparison views, especially those routinely obtained. Within the past two years there have been two studies on this problem. In 1977, a survey4 of pediatric radiologists throughout the United States and Canada sought to determine individual application of comparison views, whether selective or routine; factors that influence this use; extent of comparison views, whether single or multiple; and cost of the additional radiographic studies.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    URL: Article
    DOI: 10.1542/peds.65.1.A57
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 1980
    detail.hit.zdb_id: 1477004-0
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  • 5
    Online Resource
    Online Resource
    Excretory Urography for Evaluation of Enuresis
    American Academy of Pediatrics (AAP) ; 1980
    In:  Pediatrics Vol. 65, No. 3 ( 1980-03-01), p. 644-645
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 65, No. 3 ( 1980-03-01), p. 644-645
    Abstract: Enuresis is the involuntary discharge of urine occurring beyond the age when control of the urinary bladder should have been acquired.1 Eighty percent of children with enuresis have problems staying dry at night, 5% in the day, and 15% both day and night.2 The age at which children can be expected to stay dry at night is not well established and is often cause for extreme concern for parents and children alike. Most children are still not dry at night by age 2 years. In a study of 315 children, Klackenberg reported 87% dry by 3 years and 96% dry by 6 years. Essen and Peckham,4 reviewing the records of 12,000 children, found enuresis more prevalent in older ages. More than 10% of their patients were enuretic between ages 5 and 7 years and almost 5% were still having problems at 11 years of age. The etiology of enuresis is also difficult to define, and many different theories have been advanced. Bindelglas5 grouped these into five major categories: (1) organo-urogenic, including urologic malformations; (2) psychogenic; (3) developmental; (4) genetic; (5) environmental. The first of these categories must be of primary concern to the physician when confronted with an enuretic child, ie, could the symptoms possibly reflect a surgically correctable urologic abnormality? Radiologic procedures such as excretory urography and micturition cystourethrography are the studies usually relied on to exclude an underlying anatomic lesion. Because of the potential risk and expense of any radiologic procedure as well as the possible low yield in this condition, the Committee on Radiology examined the utility of these studies in the routine evaluation of enuresis.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    URL: Article
    DOI: 10.1542/peds.65.3.644
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 1980
    detail.hit.zdb_id: 1477004-0
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    Online Resource
  • 6
    Online Resource
    Online Resource
    Comparison Radiographs of Extremities in Childhood: Recommended Usage
    American Academy of Pediatrics (AAP) ; 1980
    In:  Pediatrics Vol. 65, No. 3 ( 1980-03-01), p. 646-647
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 65, No. 3 ( 1980-03-01), p. 646-647
    Abstract: Extremity injuries, a common problem in pediatric practice, are responsible for a significant number of radiographic examinations performed on children each year. Radiologic diagnosis in these injuries may be complicated by the variable appearance of the growing skeleton, especially around the epiphyses and the physeal plate. In the past, it has been a common and accepted practice for pediatricians, generalists, orthopedic surgeons, and radiologists to obtain routinely radiographs of the uninjured limb1-3 for comparison with those of the injured extremity to rule out subtle fractures or dislocations. Recently, increasing concern about potential dangers of ionizing radiation, coupled with agitation from insurance carriers and governmental agencies to reduce escalating medical costs, has resulted in mounting pressure to limit diagnostic radiographic examinations. At the same time, however, rising malpractice litigation has, in many instances, forced physicians to obtain additional radiographic studies to "protect" themselves, especially in trauma cases. Radiographs of traumatized extremities contribute significant numbers of medicolegally oriented radiologic examinations each year. Although comparison views are no doubt helpful in some instances, until recently there has not been any effort to document the extent of use or diagnostic value of comparison views, especially those routinely obtained. Within the past two years there have been two studies on this problem. In 1977, a survey4 of pediatric radiologists throughout the United States and Canada sought to determine individual application of comparison views, whether selective or routine; factors that influence this use; extent of comparison views, whether single or multiple; and cost of the additional radiographic studies.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    URL: Article
    DOI: 10.1542/peds.65.3.646
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 1980
    detail.hit.zdb_id: 1477004-0
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  • 7
    Online Resource
    Online Resource
    Management of Pediatric Trauma
    American Academy of Pediatrics (AAP) ; 2016
    In:  Pediatrics Vol. 138, No. 2 ( 2016-08-01)
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 138, No. 2 ( 2016-08-01)
    Abstract: Injury is still the number 1 killer of children ages 1 to 18 years in the United States (http://www.cdc.gov/nchs/fastats/children.htm). Children who sustain injuries with resulting disabilities incur significant costs not only for their health care but also for productivity lost to the economy. The families of children who survive childhood injury with disability face years of emotional and financial hardship, along with a significant societal burden. The entire process of managing childhood injury is enormously complex and varies by region. Only the comprehensive cooperation of a broadly diverse trauma team will have a significant effect on improving the care of injured children.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    URL: Article
    DOI: 10.1542/peds.2016-1569
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2016
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  • 8
    Online Resource
    Online Resource
    Comparison of Two Strategies for Surfactant Prophylaxis in Very Premature Infants: A Multicenter Randomized Trial
    American Academy of Pediatrics (AAP) ; 1998
    In:  Pediatrics Vol. 101, No. 6 ( 1998-06-01), p. 1006-1012
    Details
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 101, No. 6 ( 1998-06-01), p. 1006-1012
    Abstract: Introduction. Previous trials of surfactant therapy in premature infants have demonstrated a survival advantage associated with prophylactic therapy as an immediate bolus, compared with the rescue treatment of established respiratory distress syndrome. The optimal strategy for prophylactic therapy, however, remains controversial. When administered as an endotracheal bolus immediately after delivery, surfactant mixes with the absorbing fetal lung fluid and may reach the alveoli before the onset of lung injury. This approach, however, causes a brief delay in the initiation of standard neonatal resuscitation, including positive pressure ventilation, and is associated with a risk for surfactant delivery into the right main stem bronchus or esophagus. As an alternative approach, surfactant prophylaxis may be administered in small aliquots soon after resuscitation and confirmation of endotracheal tube position. Although this strategy has substantial logistical advantages in clinical practice, its efficacy has not been established. Objective. The purpose of this study was to determine whether the established benefits of the immediate bolus strategy for surfactant prophylaxis could still be achieved using a postventilatory aliquot strategy after initial standard resuscitation and stabilization. Design. Multicenter randomized clinical trial with patients randomized before delivery to immediate bolus or postventilatory aliquot therapy. Participants. Inborn premature infants delivered to mothers at an estimated gestational age of 24[07] to 28[67] weeks. Interventions. Those infants who were randomized to the immediate bolus strategy were intubated as rapidly as possible after birth, and a 3-mL intratracheal bolus of calf lung surfactant extract (Infasurf) was administered before the initiation of positive pressure ventilation. Those infants who were randomized to the postventilatory aliquot strategy received standard resuscitation measures with intubation by 5 minutes of age, if not required earlier. At 10 minutes after birth, 3 mL of surfactant was administered in 4 divided aliquots of 0.75 mL each. Patients in both groups were eligible to receive up to three additional doses of surfactant as rescue therapy in the neonatal intensive care unit, if needed. Outcome Measures. The primary outcome variable was survival to discharge to home. Secondary variables included neonatal complications and requirement for oxygen therapy at 36 weeks' postmenstrual age. Results. Among three centers, 651 infants were enrolled and randomized before delivery. Survival to discharge to home was similar for the two strategies for surfactant therapy as prophylaxis: 76% for the immediate bolus group and 80% for the postventilatory aliquot group. In a secondary analysis, the rate of supplemental oxygen administration at 36 weeks' postmenstrual age was 18% for the immediate bolus group and 13% for the postventilatory aliquot group. Conclusions. Survival to discharge to home was similar with immediate bolus and postventilatory aliquot strategies for surfactant prophylaxis. Because of its logistical advantages in the delivery room and its beneficial effects on prolonged oxygen requirements, we recommend the postventilatory aliquot strategy for surfactant prophylaxis of premature infants delivered before 29 weeks' gestation.
    Type of Medium: Online Resource
    ISSN: 1098-4275 , 0031-4005
    URL: Article
    DOI: 10.1542/peds.101.6.1006
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 1998
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