Prophylactic cyclo-oxygenase inhibitor drugs for the prevention of morbidity and mortality in extremely preterm infants: a clinical practice guideline incorporating family values and preferences
File(s)
Accepted version
Author(s)
Type
Journal Article
Abstract
Importance: Prophylactic cyclooxygenase inhibitors (COX-Is) such as indomethacin, ibuprofen and acetaminophen may prevent morbidity and mortality in extremely preterm infants (born ≤28 weeks’ gestation). However, there is controversy around which COX-I, if any, is the most effective and safest, which has resulted in considerable variability in clinical practice.
Objective: To develop rigorous and transparent clinical practice guideline recommendations for the prophylactic use of COX-I drugs for the prevention of mortality and morbidity in extremely preterm infants.
Methods: The GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence-to-Decision framework for multiple comparisons was used to develop the guideline recommendations. A 12-member panel, including five experienced neonatal care providers, two methods experts, one pharmacist, two parents of former extremely preterm infants and two adults born extremely preterm, was convened. A rating of the most important clinical outcomes was established a priori. Evidence from a Cochrane network meta-analysis, and a cross-sectional mixed-methods study exploring family values and preferences were used as the primary sources of evidence.
Recommendations: The panel recommended that prophylaxis with intravenous indomethacin may be considered in extremely preterm infants [conditional recommendation, moderate certainty in estimate of effects]. Shared decision making with parents was encouraged to evaluate their values and preferences prior to therapy. The panel recommended against routine use of ibuprofen prophylaxis in this gestational age group [conditional recommendation, low certainty in the estimate of effects]. The panel strongly recommended against use of prophylactic acetaminophen [strong recommendation, very low certainty in estimate of effects] until further research evidence is available.
Objective: To develop rigorous and transparent clinical practice guideline recommendations for the prophylactic use of COX-I drugs for the prevention of mortality and morbidity in extremely preterm infants.
Methods: The GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence-to-Decision framework for multiple comparisons was used to develop the guideline recommendations. A 12-member panel, including five experienced neonatal care providers, two methods experts, one pharmacist, two parents of former extremely preterm infants and two adults born extremely preterm, was convened. A rating of the most important clinical outcomes was established a priori. Evidence from a Cochrane network meta-analysis, and a cross-sectional mixed-methods study exploring family values and preferences were used as the primary sources of evidence.
Recommendations: The panel recommended that prophylaxis with intravenous indomethacin may be considered in extremely preterm infants [conditional recommendation, moderate certainty in estimate of effects]. Shared decision making with parents was encouraged to evaluate their values and preferences prior to therapy. The panel recommended against routine use of ibuprofen prophylaxis in this gestational age group [conditional recommendation, low certainty in the estimate of effects]. The panel strongly recommended against use of prophylactic acetaminophen [strong recommendation, very low certainty in estimate of effects] until further research evidence is available.
Date Issued
2024-04-18
Date Acceptance
2023-06-23
Citation
Archives of Disease in Childhood: Fetal and Neonatal Edition, 2024, 109 (3), pp.232-238
ISSN
1359-2998
Publisher
BMJ Publishing Group
Start Page
232
End Page
238
Journal / Book Title
Archives of Disease in Childhood: Fetal and Neonatal Edition
Volume
109
Issue
3
Copyright Statement
© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ. This article has been accepted for publication in Archives of Disease in Childhood. Fetal and Neonatal Edition 2023 following peer review, and the Version of Record can be accessed online at http://dx.doi.org/10.1136/archdischild-2023-325445
Publication Status
Published
Date Publish Online
2023-07-07