Bronchopulmonary dysplasia

Furosemide Safety in Preterm Infants at Risk for Bronchopulmonary Dysplasia: A Randomized Clinical Trial

Posted on by Jeannine Sato

The Journal of Pediatrics • April 2025

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Greenberg RG, Lang J, Smith PB, Shekhawat P, Courtney SE, Hudak ML, Moya F, Iyengar A, Eldemerdash A, Bloom B, Go M, Hanna M, Rhein L, Aliaga S, Lewis T, Febre A, Kiefer AS, Bhatt-Mehta V, Khoury JA, Selewski D, Anand R, Martz K, Payne EH, Zimmerman KO, Benjamin DK Jr, Laughon M; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.

The objective of this study was to evaluate the safety of furosemide in preterm infants at the risk of developing bronchopulmonary dysplasia (BPD). This multicenter, randomized, dose-escalating, placebo-controlled trial enrolled infants born <29 weeks gestational age at 7-28 days postnatal age and at risk for BPD. In preterm infants, furosemide did not increase the overall incidence of AEs, hearing loss, or nephrocalcinosis, but did increase the incidence of electrolyte abnormalities. Furosemide given for 28 consecutive days was not associated with a difference in moderate-to-severe BPD or death at 36 weeks postmenstrual age.

Safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia: Rationale and methods of a phase II randomized trial

Posted on by Kayla Korzekwinski

Contemporary Clinical Trials Communications • December 2022

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Lang JE, Hornik CD, Martz K, Jacangelo J, Anand R, Greenberg R, Hornik C, Zimmerman K, Smith PB, Benjamin DK, Laughon M
Bronchopulmonary dysplasia (BPD) is a disease of chronic respiratory insufficiency stemming from premature birth and iatrogenic lung injury leading to many complications. BPD is the most common pulmonary sequela of prematurity and is often fatal; however, there remains no FDA-approved therapies to treat or prevent BPD. Sildenafil is increasingly used off-label in premature infants despite scant safety and efficacy data. We developed the phase II SIL02 trial to describe the safety, pharmacokinetics and preliminary effectiveness of intravenous and enteral sildenafil in premature infants at risk for BPD.

Dosing and Safety of Off-label Use of Caffeine Citrate in Premature Infants

Posted on by Kayla Korzekwinski

Journal of Pediatrics • August 2019

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Puia-Dumitrescu M, Smith PB, Zhao J, Soriano A, Payne EH, Harper B, Bendel-Stenzel E, Moya F, Chhabra R, Ku L, Laughon M, Wade KC

Aim to characterize the dosing and safety of off-label caffeine citrate in a contemporary cohort of extremely premature infants. We used electronic health records (2010-2013) from 4 neonatal intensive care units to identify infants of ≤28 weeks of gestational age exposed to caffeine citrate. Of 410 infants with a median (IQR) gestational age of 26 (24-27) weeks, 95% received caffeine citrate for >0 days. Infants received a median (IQR) daily dose of 8 (5-10) mg/kg/day. Incidences of clinical events on day of caffeine citrate exposure were death 2%, patent ductus arteriosus ligation 12%, and medical and surgical necrotizing enterocolitis 5% and 4%, respectively.

Furosemide Exposure and Prevention of Bronchopulmonary Dysplasia in Premature Infants

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • May 2019

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Greenberg RG, Gayam S, Savage D, Tong A, Gorham D, Sholomon A, Clark RH, Benjamin DK, Laughon M, Smith PB

The goal of this study was to evaluate the association between furosemide exposure and risk of bronchopulmonary dysplasia (BPD) for premature infants. More days of furosemide exposure between postnatal day 7 and 36 weeks was associated with decreased risk of BPD and a combined outcome of BPD or death.

Sildenafil Exposure in the Neonatal Intensive Care Unit

Posted on by Kayla Korzekwinski

American Journal of Perinatology • February 2019

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Thompson EJ, Perez K, Hornik CP, Smith PB, Clark RH, Laughon M; Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee

Pulmonary hypertension causes substantial morbidity and mortality in infants. Although Food and Drug Administration approved to treat pulmonary arterial hypertension in adults, sildenafil is not approved for infants. This study sought to describe sildenafil exposure and associated diagnoses and outcomes in infants.

Association of Atrial Septal Defects and Bronchopulmonary Dysplasia in Premature Infants

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • November 2018

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Kumar KR, Clark DA, Kim E, Perry JD, Wright K, Thomas SA, Thompson EJ, Greenberg RG, Smith PB, Benjamin DK, Laughon MM, Clark RH, Hornik CP

This study evaluated the association between the presence of an atrial septal defect (ASD) and the odds of developing bronchopulmonary dysplasia (BPD) in premature infants. The presence of an ASD was associated with an increased odds of BPD in this cohort. Future trials should consider ASD as a potentially modifiable risk factor in this vulnerable population.

Prolonged furosemide exposure and risk of abnormal newborn hearing screen in premature infants

Posted on by Kayla Korzekwinski

Early Human Development • October 2018

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Wang LA, Smith PB, Laughon M, Goldberg RN, Ku LC, Zimmerman KO, Balevic S, Clark RH, Benjamin DK, Greenberg RG; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.

At very high doses, furosemide is linked to ototoxicity in adults, but little is known about the risk of hearing loss in premature infants exposed to furosemide. Our aim was to evaluate the association between prolonged furosemide exposure and abnormal hearing screening in premature infants.

In-hospital outcomes of premature infants with severe bronchopulmonary dysplasia

Posted on by Kayla Korzekwinski

Journal of Perinatology • July 2017

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Jackson W, Hornik CP, Messina J, Guglielmo K, Watwe A, Delancy G, Valdez A, MacAuthur T, Peter-Wohl S, Smith PB, Clark R, Laughon MM

This study characterized in-hospital outcomes of premature infants diagnosed with severe bronchopulmonary dysplasia (BPD). A majority of infants diagnosed with severe BPD were discharged home by 44 weeks of postmenstrual age. These results may inform discussions with families regarding the expected hospital course of infants diagnosed with severe BPD.

Risk Factors and In-Hospital Outcomes Following Tracheostomy in Infants

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • June 2017

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Lee JH, Smith PB, Quek MBH, Laughon MM, Clark RH, Hornik CP

This study analyzed an electronic medical record from 348 NICUs from 1997–2012 and evaluated the associations between infant demographics, diagnoses, and pre-tracheostomy cardio-pulmonary support with in-hospital mortality. It also determined the trends in use of infant tracheostomy over time. Tracheostomy is uncommonly performed in hospitalized infants, but the associated mortality is high. Risk factors for increased in-hospital mortality after tracheostomy include GA near term, SGA, and pulmonary diagnoses.

Respiratory Support for Very Low Birth Weight Infants Receiving Dexamethasone

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • April 2017

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Virkud YV, Hornik CP, Benjamin DK, Laughon MM, Clark RH, Greenberg RG, Smith PB.

To assess how neonatal intensive care units followed the American Academy of Pediatrics guidelines for use of dexamethasone in preterm infants by evaluating respiratory support at the time of dexamethasone administration. This is an observational study of infants discharged from one of 290 neonatal intensive care units from 2003 to 2010. The cohort included very low birth weight (<1500 g birth weight) infants born at ≤32 weeks gestational age. The main outcome was respiratory support at time of exposure to dexamethasone.