Inhaled Nitric Oxide Treatment of Early Pulmonary Hypertension to Reduce the Risk of Death or Bronchopulmonary Dysplasia in Infants Born Extremely Preterm: A Masked Randomized Controlled Trial
To determine whether inhaled nitric oxide (iNO) treatment of early pulmonary hypertension (PH) would decrease the risk of death or bronchopulmonary dysplasia (BPD) among infants born extremely preterm. This was a single-center, masked, randomized controlled trial involving infants born at
Gespeichert in:
| Veröffentlicht in: | The Journal of pediatrics 2024-12, Vol.278, p.114427, Article 114427 |
|---|---|
| Hauptverfasser: | , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | |
|---|---|
| container_issue | |
| container_start_page | 114427 |
| container_title | The Journal of pediatrics |
| container_volume | 278 |
| creator | Mirza, Hussnain Garcia, Jorge Zussman, Matthew Wadhawan, Rajan Pepe, Julie Oh, William |
| description | To determine whether inhaled nitric oxide (iNO) treatment of early pulmonary hypertension (PH) would decrease the risk of death or bronchopulmonary dysplasia (BPD) among infants born extremely preterm.
This was a single-center, masked, randomized controlled trial involving infants born at |
| doi_str_mv | 10.1016/j.jpeds.2024.114427 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_3146567980</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0022347624005304</els_id><sourcerecordid>3146567980</sourcerecordid><originalsourceid>FETCH-LOGICAL-e1101-d1430f932b2f4dae60324503c909ae48d574ea6a3f735cbd626f39db2c79f5c33</originalsourceid><addsrcrecordid>eNo9kc9uEzEQxi0EoqHwBEjIRy4b_G-9WSQObZrSSIWiKJwtx55VnO7aW9uLmj4dj8YuKZxmDt838838EHpPyZwSKj8d5ocebJozwsScUiFY9QLNKKmrQi44f4lmhDBWcFHJM_QmpQMhpBaEvEZnvJaCU0pn6Pfa73ULFn93OTqD7x6dBbyNoHMHPuPQ4JWO7RH_GNoueB2P-ObYQ8zgkwse54A3YAcDOO8Bb1y6nyxXo32PQ8SXMXizD_1_89Ux9a1OTmPn8do32ueEL0P0ePWYI3QwrYqQIXaf8QX-ptP9GG6jvQ2dexrbZfA5hnaKvI1Ot2_Rq0a3Cd4913P083q1Xd4Ut3df18uL2wLo-K3CUsFJU3O2Y42wGiThTJSEm5rUGsTClpUALTVvKl6anZVMNry2O2aquikN5-fo42luH8PDACmrziUDbas9hCEpToUsZVUvyCj98Cwddh1Y1UfXjberf18fBV9OAhgD_3IQVTIOvAHrIpisbHCKEjVRVgf1l7KaKKsTZf4HZ--dnQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3146567980</pqid></control><display><type>article</type><title>Inhaled Nitric Oxide Treatment of Early Pulmonary Hypertension to Reduce the Risk of Death or Bronchopulmonary Dysplasia in Infants Born Extremely Preterm: A Masked Randomized Controlled Trial</title><source>Elsevier ScienceDirect Journals Complete</source><creator>Mirza, Hussnain ; Garcia, Jorge ; Zussman, Matthew ; Wadhawan, Rajan ; Pepe, Julie ; Oh, William</creator><creatorcontrib>Mirza, Hussnain ; Garcia, Jorge ; Zussman, Matthew ; Wadhawan, Rajan ; Pepe, Julie ; Oh, William</creatorcontrib><description>To determine whether inhaled nitric oxide (iNO) treatment of early pulmonary hypertension (PH) would decrease the risk of death or bronchopulmonary dysplasia (BPD) among infants born extremely preterm.
This was a single-center, masked, randomized controlled trial involving infants born at <29 weeks’ gestation and requiring positive pressure ventilation. Exclusion criteria included infants of COVID-19 positive mothers, large patent ductus arteriosus with left to right shunting, left ventricle dysfunction (ejection fraction <40%), significant congenital anomalies/genetic disorders or iNO treatment by clinicians prior to the study echocardiogram. Initial echocardiogram was performed at 72+24 hours of life to randomize infants with early PH into 2 study arms (iNO vs placebo). Serial echocardiograms were performed every 24-48 hours, up to 14 days of life. Treatment was weaned until PH resolved (responders) or if no improvement was documented >72-hours (non-responders). Primary outcome was death or BPD at 36-weeks postmenstrual age.
From July 2019 to October 2023, 683 eligible infants were admitted. We excluded 88 infants; 413 mothers declined consent or were not approached. iNO treatment was clinically started for 51 infants due to hypoxic respiratory failure. Screening echocardiograms were completed for 180 infants; of these, 32 infants with early PH were randomized to iNO or placebo groups. After a planned interim analysis, termination of the trial was recommended by the Data Safety Monitoring Committee because of futility.
Conclusion iNO treatment does not reduce the risk of BPD or death among extremely preterm infants with echocardiographic evidence of early pulmonary hypertension without hypoxic respiratory failure.</description><identifier>ISSN: 0022-3476</identifier><identifier>ISSN: 1097-6833</identifier><identifier>EISSN: 1097-6833</identifier><identifier>DOI: 10.1016/j.jpeds.2024.114427</identifier><identifier>PMID: 39643111</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Bronchopulmonary Dysplasia ; delayed pulmonary vascular transition ; early pulmonary hypertension ; Inhaled Nitric Oxide ; Preterm Infants</subject><ispartof>The Journal of pediatrics, 2024-12, Vol.278, p.114427, Article 114427</ispartof><rights>2024</rights><rights>Copyright © 2024 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39643111$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mirza, Hussnain</creatorcontrib><creatorcontrib>Garcia, Jorge</creatorcontrib><creatorcontrib>Zussman, Matthew</creatorcontrib><creatorcontrib>Wadhawan, Rajan</creatorcontrib><creatorcontrib>Pepe, Julie</creatorcontrib><creatorcontrib>Oh, William</creatorcontrib><title>Inhaled Nitric Oxide Treatment of Early Pulmonary Hypertension to Reduce the Risk of Death or Bronchopulmonary Dysplasia in Infants Born Extremely Preterm: A Masked Randomized Controlled Trial</title><title>The Journal of pediatrics</title><addtitle>J Pediatr</addtitle><description>To determine whether inhaled nitric oxide (iNO) treatment of early pulmonary hypertension (PH) would decrease the risk of death or bronchopulmonary dysplasia (BPD) among infants born extremely preterm.
This was a single-center, masked, randomized controlled trial involving infants born at <29 weeks’ gestation and requiring positive pressure ventilation. Exclusion criteria included infants of COVID-19 positive mothers, large patent ductus arteriosus with left to right shunting, left ventricle dysfunction (ejection fraction <40%), significant congenital anomalies/genetic disorders or iNO treatment by clinicians prior to the study echocardiogram. Initial echocardiogram was performed at 72+24 hours of life to randomize infants with early PH into 2 study arms (iNO vs placebo). Serial echocardiograms were performed every 24-48 hours, up to 14 days of life. Treatment was weaned until PH resolved (responders) or if no improvement was documented >72-hours (non-responders). Primary outcome was death or BPD at 36-weeks postmenstrual age.
From July 2019 to October 2023, 683 eligible infants were admitted. We excluded 88 infants; 413 mothers declined consent or were not approached. iNO treatment was clinically started for 51 infants due to hypoxic respiratory failure. Screening echocardiograms were completed for 180 infants; of these, 32 infants with early PH were randomized to iNO or placebo groups. After a planned interim analysis, termination of the trial was recommended by the Data Safety Monitoring Committee because of futility.
Conclusion iNO treatment does not reduce the risk of BPD or death among extremely preterm infants with echocardiographic evidence of early pulmonary hypertension without hypoxic respiratory failure.</description><subject>Bronchopulmonary Dysplasia</subject><subject>delayed pulmonary vascular transition</subject><subject>early pulmonary hypertension</subject><subject>Inhaled Nitric Oxide</subject><subject>Preterm Infants</subject><issn>0022-3476</issn><issn>1097-6833</issn><issn>1097-6833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNo9kc9uEzEQxi0EoqHwBEjIRy4b_G-9WSQObZrSSIWiKJwtx55VnO7aW9uLmj4dj8YuKZxmDt838838EHpPyZwSKj8d5ocebJozwsScUiFY9QLNKKmrQi44f4lmhDBWcFHJM_QmpQMhpBaEvEZnvJaCU0pn6Pfa73ULFn93OTqD7x6dBbyNoHMHPuPQ4JWO7RH_GNoueB2P-ObYQ8zgkwse54A3YAcDOO8Bb1y6nyxXo32PQ8SXMXizD_1_89Ux9a1OTmPn8do32ueEL0P0ePWYI3QwrYqQIXaf8QX-ptP9GG6jvQ2dexrbZfA5hnaKvI1Ot2_Rq0a3Cd4913P083q1Xd4Ut3df18uL2wLo-K3CUsFJU3O2Y42wGiThTJSEm5rUGsTClpUALTVvKl6anZVMNry2O2aquikN5-fo42luH8PDACmrziUDbas9hCEpToUsZVUvyCj98Cwddh1Y1UfXjberf18fBV9OAhgD_3IQVTIOvAHrIpisbHCKEjVRVgf1l7KaKKsTZf4HZ--dnQ</recordid><startdate>20241204</startdate><enddate>20241204</enddate><creator>Mirza, Hussnain</creator><creator>Garcia, Jorge</creator><creator>Zussman, Matthew</creator><creator>Wadhawan, Rajan</creator><creator>Pepe, Julie</creator><creator>Oh, William</creator><general>Elsevier Inc</general><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20241204</creationdate><title>Inhaled Nitric Oxide Treatment of Early Pulmonary Hypertension to Reduce the Risk of Death or Bronchopulmonary Dysplasia in Infants Born Extremely Preterm: A Masked Randomized Controlled Trial</title><author>Mirza, Hussnain ; Garcia, Jorge ; Zussman, Matthew ; Wadhawan, Rajan ; Pepe, Julie ; Oh, William</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-e1101-d1430f932b2f4dae60324503c909ae48d574ea6a3f735cbd626f39db2c79f5c33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Bronchopulmonary Dysplasia</topic><topic>delayed pulmonary vascular transition</topic><topic>early pulmonary hypertension</topic><topic>Inhaled Nitric Oxide</topic><topic>Preterm Infants</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mirza, Hussnain</creatorcontrib><creatorcontrib>Garcia, Jorge</creatorcontrib><creatorcontrib>Zussman, Matthew</creatorcontrib><creatorcontrib>Wadhawan, Rajan</creatorcontrib><creatorcontrib>Pepe, Julie</creatorcontrib><creatorcontrib>Oh, William</creatorcontrib><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of pediatrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mirza, Hussnain</au><au>Garcia, Jorge</au><au>Zussman, Matthew</au><au>Wadhawan, Rajan</au><au>Pepe, Julie</au><au>Oh, William</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Inhaled Nitric Oxide Treatment of Early Pulmonary Hypertension to Reduce the Risk of Death or Bronchopulmonary Dysplasia in Infants Born Extremely Preterm: A Masked Randomized Controlled Trial</atitle><jtitle>The Journal of pediatrics</jtitle><addtitle>J Pediatr</addtitle><date>2024-12-04</date><risdate>2024</risdate><volume>278</volume><spage>114427</spage><pages>114427-</pages><artnum>114427</artnum><issn>0022-3476</issn><issn>1097-6833</issn><eissn>1097-6833</eissn><abstract>To determine whether inhaled nitric oxide (iNO) treatment of early pulmonary hypertension (PH) would decrease the risk of death or bronchopulmonary dysplasia (BPD) among infants born extremely preterm.
This was a single-center, masked, randomized controlled trial involving infants born at <29 weeks’ gestation and requiring positive pressure ventilation. Exclusion criteria included infants of COVID-19 positive mothers, large patent ductus arteriosus with left to right shunting, left ventricle dysfunction (ejection fraction <40%), significant congenital anomalies/genetic disorders or iNO treatment by clinicians prior to the study echocardiogram. Initial echocardiogram was performed at 72+24 hours of life to randomize infants with early PH into 2 study arms (iNO vs placebo). Serial echocardiograms were performed every 24-48 hours, up to 14 days of life. Treatment was weaned until PH resolved (responders) or if no improvement was documented >72-hours (non-responders). Primary outcome was death or BPD at 36-weeks postmenstrual age.
From July 2019 to October 2023, 683 eligible infants were admitted. We excluded 88 infants; 413 mothers declined consent or were not approached. iNO treatment was clinically started for 51 infants due to hypoxic respiratory failure. Screening echocardiograms were completed for 180 infants; of these, 32 infants with early PH were randomized to iNO or placebo groups. After a planned interim analysis, termination of the trial was recommended by the Data Safety Monitoring Committee because of futility.
Conclusion iNO treatment does not reduce the risk of BPD or death among extremely preterm infants with echocardiographic evidence of early pulmonary hypertension without hypoxic respiratory failure.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>39643111</pmid><doi>10.1016/j.jpeds.2024.114427</doi></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0022-3476 |
| ispartof | The Journal of pediatrics, 2024-12, Vol.278, p.114427, Article 114427 |
| issn | 0022-3476 1097-6833 1097-6833 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_3146567980 |
| source | Elsevier ScienceDirect Journals Complete |
| subjects | Bronchopulmonary Dysplasia delayed pulmonary vascular transition early pulmonary hypertension Inhaled Nitric Oxide Preterm Infants |
| title | Inhaled Nitric Oxide Treatment of Early Pulmonary Hypertension to Reduce the Risk of Death or Bronchopulmonary Dysplasia in Infants Born Extremely Preterm: A Masked Randomized Controlled Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-05T15%3A29%3A32IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Inhaled%20Nitric%20Oxide%20Treatment%20of%20Early%20Pulmonary%20Hypertension%20to%20Reduce%20the%20Risk%20of%20Death%20or%20Bronchopulmonary%20Dysplasia%20in%20Infants%20Born%20Extremely%20Preterm:%20A%20Masked%20Randomized%20Controlled%20Trial&rft.jtitle=The%20Journal%20of%20pediatrics&rft.au=Mirza,%20Hussnain&rft.date=2024-12-04&rft.volume=278&rft.spage=114427&rft.pages=114427-&rft.artnum=114427&rft.issn=0022-3476&rft.eissn=1097-6833&rft_id=info:doi/10.1016/j.jpeds.2024.114427&rft_dat=%3Cproquest_pubme%3E3146567980%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3146567980&rft_id=info:pmid/39643111&rft_els_id=S0022347624005304&rfr_iscdi=true |