A Randomized Trial Comparing NeoLight Skylife and Blanket Phototherapy in Newborn Indirect Hyperbilirubinemia
This investigation aimed to assess the safety and efficacy of NeoLight’s Skylife phototherapy device for the treatment of hyperbilirubinemia. A prospective, two-arm, randomized, unblinded controlled investigation compared total serum bilirubin (TSB) levels at baseline and discharge for a new phototh...
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| Veröffentlicht in: | Clinical pediatrics 2024-06, Vol.63 (6), p.774-778 |
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| creator | Abrams, Matthew Gosselin, Kevin Roth, Cheryl K. Hoffman, Nyssa |
| description | This investigation aimed to assess the safety and efficacy of NeoLight’s Skylife phototherapy device for the treatment of hyperbilirubinemia. A prospective, two-arm, randomized, unblinded controlled investigation compared total serum bilirubin (TSB) levels at baseline and discharge for a new phototherapy device (Skylife) with an existing phototherapy treatment in newborn infants. The repeated-measures analysis of variance (RM-ANOVA) indicated a significant main effect for the treatment condition, F(1, 54) = 4.041, P = .049. Post hoc findings showed that the Skylife group had significantly lower TSB levels following treatment (n = 28, Mean = 11.36, SD = 1.69) compared with the standard of care group (n = 28, Mean = 12.37, SD = 2.08), t(54) = 2.01, P = .049). The Skylife phototherapy device was as effective as the currently used therapy, with a shift toward a more rapid decline in bilirubin levels. Using this device may potentially decrease the length of therapy and hospitalization.Clinical Trial Registration Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns is registered at clinicaltrials.gov as NCT03599258 |
| doi_str_mv | 10.1177/00099228231190120 |
| format | Article |
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A prospective, two-arm, randomized, unblinded controlled investigation compared total serum bilirubin (TSB) levels at baseline and discharge for a new phototherapy device (Skylife) with an existing phototherapy treatment in newborn infants. The repeated-measures analysis of variance (RM-ANOVA) indicated a significant main effect for the treatment condition, F(1, 54) = 4.041, P = .049. Post hoc findings showed that the Skylife group had significantly lower TSB levels following treatment (n = 28, Mean = 11.36, SD = 1.69) compared with the standard of care group (n = 28, Mean = 12.37, SD = 2.08), t(54) = 2.01, P = .049). The Skylife phototherapy device was as effective as the currently used therapy, with a shift toward a more rapid decline in bilirubin levels. Using this device may potentially decrease the length of therapy and hospitalization.Clinical Trial Registration Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns is registered at clinicaltrials.gov as NCT03599258</description><identifier>ISSN: 0009-9228</identifier><identifier>ISSN: 1938-2707</identifier><identifier>EISSN: 1938-2707</identifier><identifier>DOI: 10.1177/00099228231190120</identifier><identifier>PMID: 37522330</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Bilirubin ; Bilirubin - blood ; Female ; Humans ; Hyperbilirubinemia ; Hyperbilirubinemia, Neonatal - therapy ; Infant, Newborn ; Jaundice ; Light therapy ; Male ; Neonates ; Patient safety ; Pediatrics ; Phototherapy ; Phototherapy - methods ; Prospective Studies ; Treatment Outcome ; Variance analysis</subject><ispartof>Clinical pediatrics, 2024-06, Vol.63 (6), p.774-778</ispartof><rights>The Author(s) 2023</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c320t-806f1477a8d33bc87b032fcffb75546c50c2b8e145448f4a22feece1d4f9c3543</cites><orcidid>0000-0001-8394-8793</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/00099228231190120$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/00099228231190120$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,777,781,21800,27905,27906,43602,43603</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37522330$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Abrams, Matthew</creatorcontrib><creatorcontrib>Gosselin, Kevin</creatorcontrib><creatorcontrib>Roth, Cheryl K.</creatorcontrib><creatorcontrib>Hoffman, Nyssa</creatorcontrib><title>A Randomized Trial Comparing NeoLight Skylife and Blanket Phototherapy in Newborn Indirect Hyperbilirubinemia</title><title>Clinical pediatrics</title><addtitle>Clin Pediatr (Phila)</addtitle><description>This investigation aimed to assess the safety and efficacy of NeoLight’s Skylife phototherapy device for the treatment of hyperbilirubinemia. A prospective, two-arm, randomized, unblinded controlled investigation compared total serum bilirubin (TSB) levels at baseline and discharge for a new phototherapy device (Skylife) with an existing phototherapy treatment in newborn infants. The repeated-measures analysis of variance (RM-ANOVA) indicated a significant main effect for the treatment condition, F(1, 54) = 4.041, P = .049. Post hoc findings showed that the Skylife group had significantly lower TSB levels following treatment (n = 28, Mean = 11.36, SD = 1.69) compared with the standard of care group (n = 28, Mean = 12.37, SD = 2.08), t(54) = 2.01, P = .049). The Skylife phototherapy device was as effective as the currently used therapy, with a shift toward a more rapid decline in bilirubin levels. Using this device may potentially decrease the length of therapy and hospitalization.Clinical Trial Registration Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns is registered at clinicaltrials.gov as NCT03599258</description><subject>Bilirubin</subject><subject>Bilirubin - blood</subject><subject>Female</subject><subject>Humans</subject><subject>Hyperbilirubinemia</subject><subject>Hyperbilirubinemia, Neonatal - therapy</subject><subject>Infant, Newborn</subject><subject>Jaundice</subject><subject>Light therapy</subject><subject>Male</subject><subject>Neonates</subject><subject>Patient safety</subject><subject>Pediatrics</subject><subject>Phototherapy</subject><subject>Phototherapy - methods</subject><subject>Prospective Studies</subject><subject>Treatment Outcome</subject><subject>Variance analysis</subject><issn>0009-9228</issn><issn>1938-2707</issn><issn>1938-2707</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp10U1P3DAQBmALtSoL7Q_gUlnqpZfA-CPr5Air8iGtKKL0HDnOeNeQxMFOhJZfj1dLqUTVkw_zzOvRDCFHDI4ZU-oEAMqS84ILxkpgHPbIjJWiyLgC9YHMtvVsC_bJQYz3AExALj6RfaFyzoWAGelO6a3uG9-5Z2zoXXC6pQvfDTq4fkWv0S_daj3SXw-b1lmkidKzVvcPONKbtR_9uMaghw11fcJPtQ89veobF9CM9HIzYKhd68JUux47pz-Tj1a3Eb-8vofk9_mPu8Vltvx5cbU4XWZGcBizAuaWSaV00QhRm0LVILg11tYqz-Xc5GB4XSCTuZSFlZpzi2iQNdKWRuRSHJLvu9wh-McJ41h1Lhps0-Top1jxQkoohZTzRL-9o_d-Cn2arkrLUiDnueJJsZ0ywccY0FZDcJ0Om4pBtb1F9c8tUs_X1-Sp7rB56_iz_ASOdyDqFf799v-JL5AwkOw</recordid><startdate>202406</startdate><enddate>202406</enddate><creator>Abrams, Matthew</creator><creator>Gosselin, Kevin</creator><creator>Roth, Cheryl K.</creator><creator>Hoffman, Nyssa</creator><general>SAGE Publications</general><general>Westminster Publications, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7QR</scope><scope>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-8394-8793</orcidid></search><sort><creationdate>202406</creationdate><title>A Randomized Trial Comparing NeoLight Skylife and Blanket Phototherapy in Newborn Indirect Hyperbilirubinemia</title><author>Abrams, Matthew ; Gosselin, Kevin ; Roth, Cheryl K. ; Hoffman, Nyssa</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c320t-806f1477a8d33bc87b032fcffb75546c50c2b8e145448f4a22feece1d4f9c3543</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Bilirubin</topic><topic>Bilirubin - blood</topic><topic>Female</topic><topic>Humans</topic><topic>Hyperbilirubinemia</topic><topic>Hyperbilirubinemia, Neonatal - therapy</topic><topic>Infant, Newborn</topic><topic>Jaundice</topic><topic>Light therapy</topic><topic>Male</topic><topic>Neonates</topic><topic>Patient safety</topic><topic>Pediatrics</topic><topic>Phototherapy</topic><topic>Phototherapy - methods</topic><topic>Prospective Studies</topic><topic>Treatment Outcome</topic><topic>Variance analysis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Abrams, Matthew</creatorcontrib><creatorcontrib>Gosselin, Kevin</creatorcontrib><creatorcontrib>Roth, Cheryl K.</creatorcontrib><creatorcontrib>Hoffman, Nyssa</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Chemoreception Abstracts</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical pediatrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Abrams, Matthew</au><au>Gosselin, Kevin</au><au>Roth, Cheryl K.</au><au>Hoffman, Nyssa</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Randomized Trial Comparing NeoLight Skylife and Blanket Phototherapy in Newborn Indirect Hyperbilirubinemia</atitle><jtitle>Clinical pediatrics</jtitle><addtitle>Clin Pediatr (Phila)</addtitle><date>2024-06</date><risdate>2024</risdate><volume>63</volume><issue>6</issue><spage>774</spage><epage>778</epage><pages>774-778</pages><issn>0009-9228</issn><issn>1938-2707</issn><eissn>1938-2707</eissn><abstract>This investigation aimed to assess the safety and efficacy of NeoLight’s Skylife phototherapy device for the treatment of hyperbilirubinemia. A prospective, two-arm, randomized, unblinded controlled investigation compared total serum bilirubin (TSB) levels at baseline and discharge for a new phototherapy device (Skylife) with an existing phototherapy treatment in newborn infants. The repeated-measures analysis of variance (RM-ANOVA) indicated a significant main effect for the treatment condition, F(1, 54) = 4.041, P = .049. Post hoc findings showed that the Skylife group had significantly lower TSB levels following treatment (n = 28, Mean = 11.36, SD = 1.69) compared with the standard of care group (n = 28, Mean = 12.37, SD = 2.08), t(54) = 2.01, P = .049). The Skylife phototherapy device was as effective as the currently used therapy, with a shift toward a more rapid decline in bilirubin levels. 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| subjects | Bilirubin Bilirubin - blood Female Humans Hyperbilirubinemia Hyperbilirubinemia, Neonatal - therapy Infant, Newborn Jaundice Light therapy Male Neonates Patient safety Pediatrics Phototherapy Phototherapy - methods Prospective Studies Treatment Outcome Variance analysis |
| title | A Randomized Trial Comparing NeoLight Skylife and Blanket Phototherapy in Newborn Indirect Hyperbilirubinemia |
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