Displaying all 13 publications

  1. Partridge JC, Martinez AM, Nishida H, Boo NY, Tan KW, Yeung CY, et al.
    Pediatrics, 2005 Aug;116(2):e263-71.
    PMID: 16061579
    To characterize parent perceptions and satisfaction with physician counseling and delivery-room resuscitation of very low birth weight infants in countries with neonatal intensive care capacity.
  2. Habicht JP, DaVanzo J, Butz WP
    Pediatrics, 1988 Mar;81(3):456-61.
    PMID: 3344191
    If they lived in households without piped water or a toilet, Malaysian infants who did not breast-feed were five times more likely to die after 1 week of age than those who breast-fed, when other significant factors affecting infant mortality were taken into account. This is double the relative risk associated with not breast-feeding for infants born into households with toilets, whether or not they had piped water. Analogously, improvements in toilet sanitation appear to have reduced mortality twice as much among infants who did not breast-feed as among those who did. These findings, from a retrospective survey of infants born to a probability sample of 1,262 women in peninsular Malaysia, confirm the pernicious synergistic effect of poor sanitation and nonbreastfeeding that was postulated previously on theoretical grounds. Promoting and maintaining high initiation of breast-feeding is thus particularly important where poor sanitation is prevalent. Even more affluent areas should not be neglected, however, because socioeconomic improvement, including improved environmental sanitation, is often accompanied by decreased breast-feeding. Although the risk to each nonbreast-fed infant was less in those areas, infants there were less likely to breast-feed in Malaysia, and hence they made up a significant proportion of lives that could be saved by breast-feeding.
  3. Bornstein J, Roux S, Kjeld Petersen L, Huang LM, Dobson SR, Pitisuttithum P, et al.
    Pediatrics, 2021 01;147(1).
    PMID: 33386332 DOI: 10.1542/peds.2019-4035
    BACKGROUND AND OBJECTIVES: Human papillomavirus (HPV) antibody responses to the 9-valent human papillomavirus (9vHPV) vaccine among girls and boys (aged 9-14 years) receiving 2-dose regimens (months 0, 6 or 0, 12) were noninferior to a 3-dose regimen (months 0, 2, 6) in young women (aged 16-26 years) 4 weeks after last vaccination in an international, randomized, open-label trial (NCT01984697). We assessed response durability through month 36.

    METHODS: Girls received 2 (months 0 and 6 [0, 6]: n = 301; months 0 and 12 [0, 12]: n = 151) or 3 doses (months 0,2, and 6 [0, 2, 6]: n = 301); boys received 2 doses ([0, 6]: n = 301; [0, 12]: n = 150); and young women received 3 doses ([0, 2, 6]: n = 314) of 9vHPV vaccine. Anti-HPV geometric mean titers (GMTs) were assessed by competitive Luminex immunoassay (cLIA) and immunoglobulin G-Luminex immunoassay (IgG-LIA) through month 36.

    RESULTS: Anti-HPV GMTs were highest 1 month after the last 9vHPV vaccine regimen dose, decreased sharply during the subsequent 12 months, and then decreased more slowly. GMTs 2 to 2.5 years after the last regimen dose in girls and boys given 2 doses were generally similar to or greater than GMTs in young women given 3 doses. Across HPV types, most boys and girls who received 2 doses (cLIA: 81%-100%; IgG-LIA: 91%-100%) and young women who received 3 doses (cLIA: 78%-98%; IgG-LIA: 91%-100%) remained seropositive 2 to 2.5 years after the last regimen dose.

    CONCLUSIONS: Antibody responses persisted through 2 to 2.5 years after the last dose of a 2-dose 9vHPV vaccine regimen in girls and boys. In girls and boys, antibody responses generated by 2 doses administered 6 to 12 months apart may be sufficient to induce high-level protective efficacy through at least 2 years after the second dose.

  4. Janvier A, Lantos J, Aschner J, Barrington K, Batton B, Batton D, et al.
    Pediatrics, 2016 09;138(3).
    PMID: 27489297 DOI: 10.1542/peds.2016-0655
    For parents, the experience of having an infant in the NICU is often psychologically traumatic. No parent can be fully prepared for the extreme stress and range of emotions of caring for a critically ill newborn. As health care providers familiar with the NICU, we thought that we understood the impact of the NICU on parents. But we were not prepared to see the children in our own families as NICU patients. Here are some of the lessons our NICU experience has taught us. We offer these lessons in the hope of helping health professionals consider a balanced view of the NICU's impact on families.
  5. Khoo EJ, Schremmer RD, Diekema DS, Lantos JD
    Pediatrics, 2017 Mar;139(3).
    PMID: 28174202 DOI: 10.1542/peds.2016-2795
    When minors are asked to assist medical educators by acting as standardized patients (SPs), there is a potential for the minors to be exploited. Minors deserve protection from exploitation. Such protection has been written into regulations governing medical research and into child labor laws. But there are no similar guidelines for minors' work in medical education. This article addresses the question of whether there should be rules. Should minors be required to give their informed consent or assent? Are there certain practices that could cause harm for the children who become SPs? We present a controversial case and ask a number of experts to consider the ethical issues that arise when minors are asked to act as SPs in medical education.
  6. Williams C
    Pediatrics, 1970 Sep;46(3):448-55.
    PMID: 5454800
    Matched MeSH terms: Pediatrics*
  7. Oei JL, Saugstad OD, Lui K, Wright IM, Smyth JP, Craven P, et al.
    Pediatrics, 2017 01;139(1).
    PMID: 28034908 DOI: 10.1542/peds.2016-1452
    BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O2) (≤30%) are recommended for preterm resuscitation to avoid oxidative injury and cerebral ischemia. Effects on long-term outcomes are uncertain. We aimed to determine the effects of using room air (RA) or 100% O2 on the combined risk of death and disability at 2 years in infants <32 weeks' gestation.

    METHODS: A randomized, unmasked study designed to determine major disability and death at 2 years in infants <32 weeks' gestation after delivery room resuscitation was initiated with either RA or 100% O2 and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission.

    RESULTS: Of 6291 eligible patients, 292 were recruited and 287 (mean gestation: 28.9 weeks) were included in the analysis (RA: n = 144; 100% O2: n = 143). Recruitment ceased in June 2014, per the recommendations of the Data and Safety Monitoring Committee owing to loss of equipoise for the use of 100% O2. In non-prespecified analyses, infants <28 weeks who received RA resuscitation had higher hospital mortality (RA: 10 of 46 [22%]; than those given 100% O2: 3 of 54 [6%]; risk ratio: 3.9 [95% confidence interval: 1.1-13.4]; P = .01). Respiratory failure was the most common cause of death (n = 13).

    CONCLUSIONS: Using RA to initiate resuscitation was associated with an increased risk of death in infants <28 weeks' gestation. This study was not a prespecified analysis, and it was underpowered to address this post hoc hypothesis reliably. Additional data are needed.

  8. Fraga MV, Stoller JZ, Glau CL, De Luca D, Rempell RG, Wenger JL, et al.
    Pediatrics, 2019 11;144(5).
    PMID: 31615954 DOI: 10.1542/peds.2019-1401
    Point-of-care ultrasound is currently widely used across the landscape of pediatric care. Ultrasound machines are now smaller, are easier to use, and have much improved image quality. They have become common in emergency departments, ICUs, inpatient wards, and outpatient clinics. Recent growth of supportive evidence makes a strong case for using point-of-care ultrasound for pediatric interventions such as vascular access (in particular, central-line placement), lumbar puncture, fluid drainage (paracentesis, thoracentesis, pericardiocentesis), suprapubic aspiration, and soft tissue incision and drainage. Our review of this evidence reveals that point-of-care ultrasound has become a powerful tool for improving procedural success and patient safety. Pediatric patients and clinicians performing procedures stand to benefit greatly from point-of-care ultrasound, because seeing is believing.
  9. Olusanya BO, Wright SM, Nair MKC, Boo NY, Halpern R, Kuper H, et al.
    Pediatrics, 2020 07;146(1).
    PMID: 32554521 DOI: 10.1542/peds.2019-2623
    BACKGROUND: Estimates of children and adolescents with disabilities worldwide are needed to inform global intervention under the disability-inclusive provisions of the Sustainable Development Goals. We sought to update the most widely reported estimate of 93 million children <15 years with disabilities from the Global Burden of Disease Study 2004.

    METHODS: We analyzed Global Burden of Disease Study 2017 data on the prevalence of childhood epilepsy, intellectual disability, and vision or hearing loss and on years lived with disability (YLD) derived from systematic reviews, health surveys, hospital and claims databases, cohort studies, and disease-specific registries. Point estimates of the prevalence and YLD and the 95% uncertainty intervals (UIs) around the estimates were assessed.

    RESULTS: Globally, 291.2 million (11.2%) of the 2.6 billion children and adolescents (95% UI: 249.9-335.4 million) were estimated to have 1 of the 4 specified disabilities in 2017. The prevalence of these disabilities increased with age from 6.1% among children aged <1 year to 13.9% among adolescents aged 15 to 19 years. A total of 275.2 million (94.5%) lived in low- and middle-income countries, predominantly in South Asia and sub-Saharan Africa. The top 10 countries accounted for 62.3% of all children and adolescents with disabilities. These disabilities accounted for 28.9 million YLD or 19.9% of the overall 145.3 million (95% UI: 106.9-189.7) YLD from all causes among children and adolescents.

    CONCLUSIONS: The number of children and adolescents with these 4 disabilities is far higher than the 2004 estimate, increases from infancy to adolescence, and accounts for a substantial proportion of all-cause YLD.

  10. Khoo EJ, Duenas DM, Wilfond BS, Gelinas L, Matheny Antommaria AH
    Pediatrics, 2023 Feb 01;151(2).
    PMID: 36660851 DOI: 10.1542/peds.2021-055702
    When incentives are offered to parents and their children to partake in research, there are concerns that parents may be unduly influenced by the incentives, and the children may be exploited. We present a case from a low- and middle-income country and consider the ethical issues that arise when the children are asked to participate in a multinational, double-blind, randomized, placebo-controlled trial of the effects of a nutritional supplement on growth. The first commenter, from Malaysia, notes that their residents might not share Americans' expectations regarding children's role in the consent process from a cultural perspective, which may alter the analysis of the concerns. The authors of the second commentary emphasize the use of incentives that benefit the child participant rather than their parent or are provided directly to the child participant to address the concerns. The third commentator discusses the importance of minimizing the study's risks and balancing the benefits and the risks, which attenuates the concerns.
  11. Baba A, Webbe J, Butcher NJ, Rodrigues C, Stallwood E, Goren K, et al.
    Pediatrics, 2023 Sep 01;152(3).
    PMID: 37641881 DOI: 10.1542/peds.2022-060751
    OBJECTIVES: Clear outcome reporting in clinical trials facilitates accurate interpretation and application of findings and improves evidence-informed decision-making. Standardized core outcomes for reporting neonatal trials have been developed, but little is known about how primary outcomes are reported in neonatal trials. Our aim was to identify strengths and weaknesses of primary outcome reporting in recent neonatal trials.

    METHODS: Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials' primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed.

    RESULTS: Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity.

    CONCLUSIONS: Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.

  12. Webbe J, Baba A, Butcher NJ, Rodrigues C, Stallwood E, Goren K, et al.
    Pediatrics, 2023 Sep 01;152(3).
    PMID: 37641894 DOI: 10.1542/peds.2022-060765
    BACKGROUND AND OBJECTIVES: There is variability in the selection and reporting of outcomes in neonatal trials with key information frequently omitted. This can impact applicability of trial findings to clinicians, families, and caregivers, and impair evidence synthesis. The Neonatal Core Outcomes Set describes outcomes agreed as clinically important that should be assessed in all neonatal trials, and Consolidated Standards of Reporting Trials (CONSORT)-Outcomes 2022 is a new, harmonized, evidence-based reporting guideline for trial outcomes. We reviewed published trials using CONSORT-Outcomes 2022 guidance to identify exemplars of neonatal core outcome reporting to strengthen description of outcomes in future trial publications.

    METHODS: Neonatal trials including >100 participants per arm published between 2015 to 2020 with a primary outcome included in the Neonatal Core Outcome Set were identified. Primary outcome reporting was reviewed using CONSORT 2010 and CONSORT-Outcomes 2022 guidelines by assessors recruited from Cochrane Neonatal. Examples of clear and complete outcome reporting were identified with verbatim text extracted from trial reports.

    RESULTS: Thirty-six trials were reviewed by 39 assessors. Examples of good reporting for CONSORT 2010 and CONSORT-Outcomes 2022 criteria were identified and subdivided into 3 outcome categories: "survival," "short-term neonatal complications," and "long-term developmental outcomes" depending on the core outcomes to which they relate. These examples are presented to strengthen future research reporting.

    CONCLUSIONS: We have identified examples of good trial outcome reporting. These illustrate how important neonatal outcomes should be reported to meet the CONSORT 2010 and CONSORT-Outcomes 2022 guidelines. Emulating these examples will improve the transmission of information relating to outcomes and reduce associated research waste.

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