Nonsteroidal anti-inflammatory administration and patent ductus arteriosus ligation, a survey of practice preferences at US children’s hospitals

Slaughter, Jonathan L.; Reagan, Patricia B.; Bapat, Roopali; Newman, Thomas B.; Klebanoff, Mark A.

doi:10.1007/s00431-016-2705-y

Cited by 41 publications

(40 citation statements)

References 35 publications

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“…Over the last decade the use of prophylactic or early PDA treatment has decreased (35). This is primarily due to the results of the prophylactic and early PDA treatment RCTs that failed to show any improvement in long-term morbidities such as BPD and BPD/Death (2, 4, 6–9).…”

Section: Discussionmentioning

confidence: 99%

Prophylactic Indomethacin Compared with Delayed Conservative Management of the Patent Ductus Arteriosus in Extremely Preterm Infants: Effects on Neonatal Outcomes

Liebowitz

Clyman

2017

The Journal of Pediatrics

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Objective To determine whether prophylactic indomethacin (PINDO) has more or less morbidity than delayed conservative management of the moderate-to-large patent ductus arteriosus (PDA). Study design We performed a prospective double cohort controlled study of infants delivered at ≤27+6 weeks gestation (n=397). From January 2005 through April 2011, all infants were treated with PINDO (n=247). From May 2011 through August 2016 no infant was treated with indomethacin until at least 8 postnatal days (Conservative epoch, n=150). Echocardiograms were performed on day 7 and at planned intervals until the PDA was small or closed. A single neonatologist prospectively collected all data. Results The incidence of moderate-to-large PDA on day 7 and duration of exposure to moderate-to-large PDA were significantly less in the PINDO epoch (incidence=10%, median=2 days) than the Conservative epoch (incidence=67%, median=14 days). Ligation rates were low in both epochs (PINDO=14%, Conservative=5%). In multivariate analyses PINDO infants had a significantly lower incidence of bronchopulmonary dysplasia (BPD) (RR=0.68, CI:0.46–0.89) and BPD or Death (RR=0.78, CI: 0.62–0.95) than Conservative infants. There were no differences between the epochs in Death, IVH grades 3 & 4, NEC, or ROP receiving treatment. The effects of PINDO on BPD and BPD or death were no longer significant when analyses were adjusted for presence of a moderate-to-large PDA on day 7. The significant effects of PINDO were independent of whether or not a ligation was performed. Conclusion PINDO decreases BPD and BPD or death compared with delayed conservative PDA management. These effects are mediated by closure of the PDA.

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Section: Discussionmentioning

confidence: 99%

Prophylactic Indomethacin Compared with Delayed Conservative Management of the Patent Ductus Arteriosus in Extremely Preterm Infants: Effects on Neonatal Outcomes

Liebowitz

Clyman

2017

The Journal of Pediatrics

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“…Over the last decade the use of prophylactic or early PDA treatment has decreased (32). This is primarily due to the results of the prophylactic and early PDA treatment RCTs that failed to show any improvement in long-term morbidities (like BPD and neurodevelopment) (18, 19).…”

Section: Discussionmentioning

confidence: 99%

Effects of Prophylactic Indomethacin on Vasopressor-Dependent Hypotension in Extremely Preterm Infants

Liebowitz

Koo

Wickremasinghe

et al. 2017

The Journal of Pediatrics

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Objective To determine if a moderate-to-large PDA is responsible for vasopressor-dependent hypotension, occurring at the end of the first postnatal week. Study design We performed a retrospective double cohort controlled study of infants delivered at ≤27+6 weeks gestation (n=313). From January 2004 through April 2011, all infants were treated with prophylactic indomethacin (PINDO epoch). From May 2011 through December 2015 no infant was treated with indomethacin until at least 8 postnatal days (Conservative epoch). Echocardiograms were performed on postnatal days 6 or 7. Hypotension was managed by a predefined protocol. The primary outcome was the incidence of dopamine-dependent hypotension, defined as having received at least 6 µg/kg/min dopamine for at least 24 hours during postnatal days 4–7. Results As expected, the incidence of moderate-to-large PDA at the end of the first week differed significantly between epochs (PINDO=8%; Conservative=64%). In multivariate analyses, PINDO infants had a significantly lower incidence of vasopressor-dependent hypotension (11%) than Conservative infants (21%)(OR=0.40, 95% CI: 0.20–0.82). PINDO infants also required less Mean Airway Pressure, had a lower Respiratory Severity Score and lower Mode of Ventilation Score than Conservative infants during postnatal days 4–7. The effects of PINDO on both the incidence of vasopressor-dependent hypotension and the need for respiratory support were no longer significant when analyses were adjusted for “presence or absence of a moderate-to-large PDA”. Conclusion PINDO decreases vasopressor-dependent hypotension and the need for respiratory support at the end of the first postnatal week. These effects are mediated by closure of the PDA.

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“…1 Most physicians at the NICUs included within PHIS use echocardiograms to inform their PDA treatment decisions, but some base treatment on the presence of a murmur, a less-sensitive method. 14 Regardless of actual PDA presence, we assume that treated infants were more likely to receive a PDA diagnosis. Therefore, restricting our analysis solely to infants formally diagnosed with PDA may introduce bias.…”

Section: Methodsmentioning

confidence: 99%

Comparative Effectiveness of Nonsteroidal Anti-inflammatory Drug Treatment vs No Treatment for Patent Ductus Arteriosus in Preterm Infants

et al. 2017

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IMPORTANCE Patent ductus arteriosus (PDA) is associated with increased mortality and worsened respiratory outcomes, including bronchopulmonary dysplasia (BPD), in preterm infants. Nonsteroidal anti-inflammatory drugs (NSAIDs) are efficacious in closing PDA, but the effectiveness of NSAID-mediated PDA closure in improving mortality and preventing BPD is unclear.OBJECTIVE To determine the effectiveness of NSAID treatment for PDA in reducing mortality and moderate/severe BPD at 36 weeks postmenstrual age. DESIGN, SETTING, AND PARTICIPANTSThis cohort study included 12 018 infants born at 28 gestational weeks or younger discharged between January 2006 and December 2013 from neonatal intensive care units in 25 US children's hospitals included in the Pediatric Health Information System. We performed an instrumental variable analysis that incorporated clinician preference-based, institutional variation in NSAID treatment frequency to determine the effect of NSAID treatment for PDA on mortality and BPD.EXPOSURES Proportion of NSAID-treated infants born at each infant's institution within ±6 months of that infant's birth. MAIN OUTCOMES AND MEASURESThe primary composite outcome was death, moderate, or severe BPD at 36 weeks postmenstrual age. RESULTSOf the 6370 male and 5648 female infants in this study, 4995 (42%) were white, 3176 (26%) were African American, 1823 (15%) were Hispanic, and 1555 (13%) were other races/ethnicities. The proportion of NSAID-treated infants at each infant's hospital within ±6 months of that infant's birth was associated with NSAID treatment and not associated with gestation, race/ethnicity, or sex. An infant's chances of receiving NSAID treatment increased by 0.84% (95% CI, 0.8-0.9; P < .001) for every 1% increase in the annual NSAID treatment percentage at a given hospital. An instrumental variable analysis demonstrated no association between NSAID treatment and the odds of mortality or BPD (odds ratio, 0.94; 95% CI, 0.70-1.25; P = .69), mortality (odds ratio, 0.73; 95% CI, 0.43-1.13; P = .18), or BPD (odds ratio, 1.01; 95% CI, 0.73-1.45; P = .94) in survivors.CONCLUSIONS AND RELEVANCE When we incorporated clinician preference-based practice variation as an instrument to minimize the effect of unmeasured confounding, we detected no changes in the odds of mortality or moderate/severe BPD among similar preterm infants born at 28 weeks or younger following NSAID treatment for PDA initiated 2 to 28 days postnatally. Our findings agree with available randomized clinical trial evidence and support a conservative approach to PDA management.

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Nonsteroidal anti-inflammatory administration and patent ductus arteriosus ligation, a survey of practice preferences at US children’s hospitals

Cited by 41 publications

References 35 publications

Prophylactic Indomethacin Compared with Delayed Conservative Management of the Patent Ductus Arteriosus in Extremely Preterm Infants: Effects on Neonatal Outcomes

Prophylactic Indomethacin Compared with Delayed Conservative Management of the Patent Ductus Arteriosus in Extremely Preterm Infants: Effects on Neonatal Outcomes

Effects of Prophylactic Indomethacin on Vasopressor-Dependent Hypotension in Extremely Preterm Infants

Comparative Effectiveness of Nonsteroidal Anti-inflammatory Drug Treatment vs No Treatment for Patent Ductus Arteriosus in Preterm Infants

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