Prophylactic cyclo-oxygenase inhibitor drugs for the prevention of morbidity and mortality in preterm infants: a network meta-analysis

Mitra, Souvik; Gardner, Courtney E; MacLellan, Abigale; Disher, Timothy; Styranko, Danielle M; Campbell‐Yeo, Marsha; Kuhle, Stefan; Johnston, Bradley C.; Dorling, Jon

doi:10.1002/14651858.cd013846.pub2

Cited by 12 publications

(10 citation statements)

References 130 publications

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“…A recent study from Kramer et al [28] underlines these findings by introducing a bundle of quality improvement measures for IVH prevention that lead to a sustained reduction in IVH in extremely preterm infants. A recent meta-analysis revealed a reduction of severe IVH due to a prophylactic therapy with indomethacin [10] which is supported by data from the Canadian Neonatal Network with similar gestational age strata to our study cohort [29].…”

Section: Discussionsupporting

confidence: 89%

“…The use of low-dose intravenous indomethacin, i.e., 0.1 mg/kg once daily from day 1 of life, has the potential to reduce the incidence and severity of IVH [4,5], the risk for symptomatic patent ductus arteriosus (PDA), PDA surgical ligation, and mortality [6][7][8][9]. A recent metaanalysis confirmed the benefit of prophylactic indomethacin for IVH risk reduction [10]. Notably, data on long-term outcome of prophylactic indomethacin treatment is scarce.…”

Section: Introductionmentioning

confidence: 99%

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Indomethacin Prophylaxis Is Associated with Reduced Risk of Intraventricular Hemorrhage in Extremely Preterm Infants Born in the Context of Amniotic Infection Syndrome

Hanke¹,

Fortmann²,

Humberg³

et al. 2023

Neonatology

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Background: Amniotic infection syndrome (AIS) with perinatal inflammation may increase the susceptibility to intraventricular hemorrhage (IVH) in preterm infants. Given its anti-inflammatory and ductus arteriosus constricting capacities, we hypothesized that prophylactic administration of indomethacin reduces the incidence, severity, and consequences of IVH in the context of perinatal inflammation. Methods: We evaluated data of infants born between 2009 and 2020 of 22 + 0–25+6 weeks of gestation from 68 German Neonatal Network centers. The effect of indomethacin prophylaxis on outcomes was analyzed in univariate analyses and multivariate regression models including a subgroup of infants with available data on 5-year follow-up. Results: 4760 infants were included with a median gestational age of 24.6 SSW [interquartile range (IQR) 24.1w–25.2w] and a birth weight of 640 g [IQR 550–750 g]. 1767/4760 (37.1%) preterm infants were born in the context of AIS and 527/4760 (11.1%) received indomethacin prophylaxis. AIS infants receiving prophylactic indomethacin had lower rates of IVH (32.7% vs. 36.9%, p = 0.04), IVH III/IV (9.7% vs. 16.0%, p = 0.02) and the combined outcome of severe IVH or death (15.9% vs. 23.2%, p = 0.01) as compared to infants without prophylaxis. Multivariate logistic regression analyses confirmed our observations. In a subgroup analysis of 730 preterm infants at 5 years of age, we did not find any correlation between prophylactic indomethacin and intelligence quotient <70 or cerebral palsy. Conclusions: Our observational data demonstrate that prophylactic indomethacin is associated with a reduced risk of IVH in the highly vulnerable subgroup of preterm infants <26 weeks of gestation born from AIS.

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Section: Discussionsupporting

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Indomethacin Prophylaxis Is Associated with Reduced Risk of Intraventricular Hemorrhage in Extremely Preterm Infants Born in the Context of Amniotic Infection Syndrome

Hanke¹,

Fortmann²,

Humberg³

et al. 2023

Neonatology

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“…For the pilot study, we used data on use of prophylactic indomethacin, ibuprofen, and acetaminophen in preterm infants available from existing evidence published in the Cochrane Database of Systematic Reviews . For the formal study, updated evidence from the recent Cochrane review and network meta-analysis by Mitra et al was used. Evidence on prophylactic use of hydrocortisone was drawn from a 2019 individual patient data meta-analysis by Shaffer et al…”

Section: Methodsmentioning

confidence: 99%

“…Cochrane review and network meta-analysis by Mitra et al 16 was used. Evidence on prophylactic use of hydrocortisone was drawn from a 2019 individual patient data meta-analysis by Shaffer et al 17…”

Section: Jama Network Open | Pediatricsmentioning

confidence: 99%

“…As a result, our sample size was insufficient to explore potential differences in responses based on race and ethnicity, educational attainment, geographic region, or health care system. The primary rationale for limiting the sample size to 40 participants was to ensure timely study completion so that evidence from this study and the corresponding systematic review 16 remained relevant and up-todate for a guideline development exercise on this topic using the GRADE Evidence-to-Decision framework planned by members of the authoring team for Spring 2022. 26 Additional large studies are required to explore whether participant preferences and their rationale for prophylactic interventions vary based on race and ethnicity, educational attainment, and socioeconomic backgrounds.…”

Section: Limitationsmentioning

confidence: 99%

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Evaluation of Health-Related Values and Preferences of Adults Who Were Preterm Infants and Parents of Preterm Infants Concerning Use of Prophylactic Cyclooxygenase Inhibitor Drugs

et al. 2023

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ImportanceThere is wide variability in the use of prophylactic cyclooxygenase inhibitor (COX-I) drugs to prevent morbidity and mortality in preterm infants. Parents of preterm infants are rarely involved in this decision-making process.ObjectiveTo explore the health-related values and preferences of adults who were preterm infants and families of preterm infants concerning the prophylactic use of indomethacin, ibuprofen, and acetaminophen initiated within the first 24 hours after birth.Design, Setting, and ParticipantsThis cross-sectional study used direct choice experiments conducted in 2 phases of virtual video-conferenced interviews between March 3, 2021, and February 10, 2022: (1) a pilot feasibility study and (2) a formal study of values and preferences, using a predefined convenience sample. Participants included adults born very preterm (gestational age &lt;32 weeks) or parents of very preterm infants currently in the neonatal intensive care unit (NICU) or having graduated from the NICU in the last 5 years.Main Outcomes and MeasuresRelative importance of clinical outcomes, willingness to use each of the COX-Is when presented as the only option, preference for using prophylactic hydrocortisone vs indomethacin, willingness to use any of the COX-Is when all 3 options are available, and relative importance of having family values and preferences included in decision-making.ResultsOf 44 participants enrolled, 40 were included in the formal study (31 parents and 9 adults born preterm). The median gestational age of the participant or the participant’s child at birth was 26.0 (IQR, 25.0-28.8) weeks. Death (median score, 100 [IQR, 100-100]) and severe intraventricular hemorrhage (IVH) (median score, 90.0 [IQR, 80.0-100]) were rated as the 2 most critical outcomes. Based on direct choice experiments, most participants were willing to consider prophylactic indomethacin (36 [90.0%]) or ibuprofen (34 [85.0%]), but not acetaminophen (4 [10.0%]) when offered as the only option. Among participants who initially chose indomethacin (n = 36), if prophylactic hydrocortisone was offered as a potential therapy with the caveat that both cannot be used simultaneously, only 12 of 36 (33.3%) preferred to remain with indomethacin. Variability in preference was noted when all 3 COX-I options were available, indomethacin (19 [47.5%]) being the most preferred option followed by ibuprofen (16 [40.0%]), while the remainder opted for no prophylaxis (5 [12.5%]).Conclusions and RelevanceThe findings of this cross-sectional study of former preterm infants and parents of preterm infants suggest that there was minimal variability in how participants valued the main outcomes, with death and severe IVH being rated as the 2 most important undesirable outcomes. While indomethacin was the most preferred form of prophylaxis, variability was noted in the choice of COX-I interventions when participants were presented with the benefits and harms of each drug.

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Interventions for patent ductus arteriosus (PDA) in preterm infants: an overview of Cochrane Systematic Reviews

Mitra

Boode

Weisz

et al. 2023

Cochrane Database of Systematic Reviews

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Background Patent ductus arteriosus (PDA) is associated with significant morbidity and mortality in preterm infants. Several non‐pharmacological, pharmacological, and surgical approaches have been explored to prevent or treat a PDA. Objectives To summarise Cochrane Neonatal evidence on interventions (pharmacological or surgical) for the prevention of PDA and related complications, and interventions for the management of asymptomatic and symptomatic PDA in preterm infants. Methods We searched the Cochrane Database of Systematic Reviews on 20 October 2022 for ongoing and published Cochrane Reviews on the prevention and treatment of PDA in preterm (< 37 weeks' gestation) or low birthweight (< 2500 g) infants. We included all published Cochrane Reviews assessing the following categories of interventions: pharmacological therapy using prostaglandin inhibitor drugs (indomethacin, ibuprofen, and acetaminophen), adjunctive pharmacological interventions, invasive PDA closure procedures, and non‐pharmacological interventions. Two overview authors independently checked the eligibility of the reviews retrieved by the search, and extracted data from the included reviews using a predefined data extraction form. Any disagreements were resolved by discussion with a third overview author. Two overview authors independently assessed the methodological quality of the included reviews using the AMSTAR 2 (A MeaSurement Tool to Assess systematic Reviews) tool. We reported the GRADE certainty of evidence as assessed by the respective review authors using summary of findings tables. Main results We included 16 Cochrane Reviews, corresponding to 138 randomised clinical trials (RCT) and 11,856 preterm infants, on the prevention and treatment of PDA in preterm infants. One of the 16 reviews had no included studies, and therefore, did not contribute to the results. Six reviews reported on prophylactic interventions for the prevention of PDA and included pharmacological prophylaxis with prostaglandin inhibitor drugs, prophylactic surgical PDA ligation, and non‐pharmacologic interventions (chest shielding during phototherapy and restriction of fluid intake); one review reported on the use of indomethacin for the management of asymptomatic PDA; nine reviews reported on interventions for the management of symptomatic PDA, and included pharmacotherapy with prostaglandin inhibitor drugs in various routes and dosages, surgical PDA ligation, and adjunct therapies (use of furosemide and dopamine in conjunction with indomethacin). The quality of reviews varied. Two reviews were assessed to be high quality, seven reviews were of moderate quality, five of low quality, while two reviews were deemed to be of critically low quality. For prevention of PDA, prophylactic indomethacin reduces severe intraventricular haemorrhage (IVH; relative risk (RR) 0.66, 95% confidence interval (CI) 0.53 to 0.82; 14 RCTs, 2588 infants),...

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Prophylactic cyclo-oxygenase inhibitor drugs for the prevention of morbidity and mortality in preterm infants: a network meta-analysis

Cited by 12 publications

References 130 publications

Indomethacin Prophylaxis Is Associated with Reduced Risk of Intraventricular Hemorrhage in Extremely Preterm Infants Born in the Context of Amniotic Infection Syndrome

Indomethacin Prophylaxis Is Associated with Reduced Risk of Intraventricular Hemorrhage in Extremely Preterm Infants Born in the Context of Amniotic Infection Syndrome

Evaluation of Health-Related Values and Preferences of Adults Who Were Preterm Infants and Parents of Preterm Infants Concerning Use of Prophylactic Cyclooxygenase Inhibitor Drugs

Interventions for patent ductus arteriosus (PDA) in preterm infants: an overview of Cochrane Systematic Reviews

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