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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

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
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

ImportanceProphylactic cyclo-oxygenase 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.  Our objective was 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.  The 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 5 experienced neonatal care providers, 2 methods experts, 1 pharmacist, 2 parents of former extremely preterm infants and 2 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.  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.

Intensive Care Units, Neonatal, Neonatology
1359-2998
Mitra, Souvik
66762ff9-575c-49b3-bdf7-5b6a746d0164
Whitehead, Leah
3ab3442b-e223-4e55-bcb4-07898569d501
Smith, Katie
7cfbce90-4c3f-4c13-9128-c9d690958f05
MacLean, Breagh
11d76b4c-6053-414a-ae00-6142a4335881
Nixon, Rebekah
5c86ad82-027a-46ba-893b-2cf33afc714d
Veysey, Andrew
49d69b14-cd29-42f4-b2d9-b016cdf635ca
Campbell-Yeo, Marsha
fd416bfc-eef1-401e-8652-c049fb65e42a
Kuhle, Stefan
bc9c3799-2fb8-48e4-a42c-755d1d3f967a
Gale, Chris
210b7c81-9a39-460a-9ab3-54fe92a69f8e
Soll, Roger
996e4333-d0c5-4ed6-b456-02c78abcad95
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
Johnston, Bradley C.
2df71bf6-2116-43bf-b2c2-ea6a16410add
Mitra, Souvik
66762ff9-575c-49b3-bdf7-5b6a746d0164
Whitehead, Leah
3ab3442b-e223-4e55-bcb4-07898569d501
Smith, Katie
7cfbce90-4c3f-4c13-9128-c9d690958f05
MacLean, Breagh
11d76b4c-6053-414a-ae00-6142a4335881
Nixon, Rebekah
5c86ad82-027a-46ba-893b-2cf33afc714d
Veysey, Andrew
49d69b14-cd29-42f4-b2d9-b016cdf635ca
Campbell-Yeo, Marsha
fd416bfc-eef1-401e-8652-c049fb65e42a
Kuhle, Stefan
bc9c3799-2fb8-48e4-a42c-755d1d3f967a
Gale, Chris
210b7c81-9a39-460a-9ab3-54fe92a69f8e
Soll, Roger
996e4333-d0c5-4ed6-b456-02c78abcad95
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
Johnston, Bradley C.
2df71bf6-2116-43bf-b2c2-ea6a16410add

Mitra, Souvik, Whitehead, Leah, Smith, Katie, MacLean, Breagh, Nixon, Rebekah, Veysey, Andrew, Campbell-Yeo, Marsha, Kuhle, Stefan, Gale, Chris, Soll, Roger, Dorling, Jon and Johnston, Bradley C. (2023) 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. Archives of Disease in Childhood: Fetal and Neonatal Edition. (doi:10.1136/archdischild-2023-325445).

Record type: Review

Abstract

ImportanceProphylactic cyclo-oxygenase 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.  Our objective was 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.  The 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 5 experienced neonatal care providers, 2 methods experts, 1 pharmacist, 2 parents of former extremely preterm infants and 2 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.  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.

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More information

Accepted/In Press date: 23 June 2023
e-pub ahead of print date: 7 July 2023
Additional Information: © Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.
Keywords: Intensive Care Units, Neonatal, Neonatology

Identifiers

Local EPrints ID: 485072
URI: http://eprints.soton.ac.uk/id/eprint/485072
ISSN: 1359-2998
PURE UUID: d7d22d3a-bde8-4913-ae98-699b63b299e8
ORCID for Jon Dorling: ORCID iD orcid.org/0000-0002-1691-3221

Catalogue record

Date deposited: 28 Nov 2023 18:07
Last modified: 18 Mar 2024 04:16

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Contributors

Author: Souvik Mitra
Author: Leah Whitehead
Author: Katie Smith
Author: Breagh MacLean
Author: Rebekah Nixon
Author: Andrew Veysey
Author: Marsha Campbell-Yeo
Author: Stefan Kuhle
Author: Chris Gale
Author: Roger Soll
Author: Jon Dorling ORCID iD
Author: Bradley C. Johnston

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