Recommendations for an ethical treatment of newborns involved in clinical trials

Bellieni, Cv; Buonocore, Giuseppe

doi:10.1111/j.1651-2227.2009.01570.x

Cited by 12 publications

(9 citation statements)

References 29 publications

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“…In order to help institutional review boards (IRBs), we recently proposed some guidelines to perform ethically correct trials in neonatology [96]. Nevertheless, the US National Bioethics Advisory Commission suggests that in the case of person lacking judgment ability [97], nontherapeutic research involving more than a minimal risk requires approval by a federal review panel and not only by local IRBs.…”

Section: Discussionmentioning

confidence: 99%

The Ethics of Pain Clinical Trials on Persons Lacking Judgment Ability: Much to Improve

Bellieni¹,

Rocchi

Buonocore

2012

Pain Med

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Section: Discussionmentioning

confidence: 99%

The Ethics of Pain Clinical Trials on Persons Lacking Judgment Ability: Much to Improve

Bellieni¹,

Rocchi

Buonocore

2012

Pain Med

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“…49,68 In response to this statement, calls have been made to cease further conduct of placebo-controlled trials of sweet solutions for single episodes of painful procedures for neonatal pain. 49,61,62,69,70 Research and Reports in Neonatology 2015:5 submit your manuscript | www.dovepress.com…”

Section: Sweet Solutionsmentioning

confidence: 99%

Prevention and management of pain and stress in the neonate

Harrison¹,

Bueno²,

Reszel³

2015

RRN

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Neonates have blood work for newborn screening in their first days of life, and preterm and sick hospitalized infants often require repeated invasive needle-related procedures over the duration of their hospitalization. Reducing newborn infants' pain during such painful procedures is important and may reduce the risk of negative sequela of poorly treated procedural pain. High-quality synthesized evidence demonstrates analgesic effects of three pain management strategies: breastfeeding; skin-to-skin care, also referred to as kangaroo care; and small amounts of sweet solutions. These strategies are simple to use, easily accessible, and extremely cost-effective. Published neonatal and infant pain guidelines include recommendations to use these strategies prior to and during painful procedures. Yet, despite the robust evidence and pain management recommendations in guidelines and national and international organizations, knowledge has not been translated into consistent normalized care in diverse maternal newborn, neonatal, and pediatric settings where painful procedures for infants take place. There may be knowledge gaps or barriers impeding consistent use of effective pain management for newborn infants. This paper will present a brief review of methods used to assess neonatal pain, followed by a summary of the evidence supporting breastfeeding, skin-to-skin care, and sweet solutions for procedural pain reduction with a discussion about barriers and facilitators to using these strategies in the clinical setting. Finally, a review of recommendations included in current neonatal pain guidelines will be presented.

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“…Benefit can be defined as a progress in safety or efficacy in treatment. The risk/benefit balance must take into considerations the severity of the condition/disease studied, the vulnerability of the neonates and the expected improvement in comparison with an alternative existing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 been prevented and minimized [11]. They also must require minimal blood sampling [12].…”

Section: Balance Of Risk and Benefitmentioning

confidence: 99%