{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T15:16:36Z","timestamp":1786115796858,"version":"build-2736575974"},"reference-count":33,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T00:00:00Z","timestamp":1785974400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pediatr."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Neonatal respiratory distress syndrome (NRDS) is a leading cause of mortality and long-term morbidity in preterm infants; however, safe and effective surfactant delivery to the neonatal lung remains challenging. We developed a novel dual-lumen tracheal tube (NDT) enabling surfactant administration without interrupting ventilation. This study aimed to evaluate the non-inferiority of the novel NDT-based technique compared with the Less Invasive Surfactant Administration (LISA) technique in reducing the need for early invasive mechanical ventilation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The NDT, designed for a modified Intubation\u2013Surfactant\u2013Extubation (InSurE) technique (NDT-InSurE), features an embedded 0.2 mm channel. A multicenter, randomized controlled trial was conducted across six tertiary neonatal intensive care units (NICUs) in China. Preterm infants\u2009\u2264\u200932 weeks\u2019 gestation with NRDS were randomly assigned to the NDT-InSurE group (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200969) or the LISA group (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200969). The primary outcome was the requirement for mechanical ventilation within 72 h of treatment initiation due to non-invasive ventilation failure. Secondary outcomes included key clinical outcomes and major complications associated with NRDS.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Baseline characteristics were comparable between the two groups. The primary outcome occurred in 10 infants (14.5%) in the NDT-InSurE group and 13 (18.8%) in the LISA group (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.493; 95% CI, \u221212.5% to 4.0%). The upper bound of the 95% confidence interval was below the prespecified non-inferiority margin of 20%, indicating that the NDT-InSurE technique met the prespecified criterion for non-inferiority. Secondary outcomes, including total procedure duration, intubation time, duration of invasive ventilation, non-invasive ventilation, oxygen therapy, and total hospitalization time, showed no significant differences between the two groups (all\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&amp;gt;\u20090.05). However, post-intubation arterial pH was lower in the NDT-InSurE group than in the LISA group (7.27 [7.25\u20137.35] vs. 7.38 [7.32\u20137.42],\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.004). Moreover, the incidence of major complications, including bronchopulmonary dysplasia, intraventricular hemorrhage, retinopathy of prematurity, and necrotizing enterocolitis, did not differ significantly between groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>NDT-InSurE may serve as a practical alternative to LISA, particularly in settings where LISA expertise or resources are limited. Further large-scale, multicenter studies with long-term follow-up are warranted to confirm these findings and further evaluate the efficacy and safety of this technique.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>\n                      This study was registered at the China Clinical Trial Registry (\n                      <jats:ext-link>https:\/\/www.chictr.org.cn\/<\/jats:ext-link>\n                      ), Registration Number: ChiCTR2300076354.The registration date is October 7th, 2023.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fped.2026.1869213","type":"journal-article","created":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T05:32:14Z","timestamp":1785994334000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["A novel double-lumen tracheal tube-assisted InSurE versus LISA in preterm infants with RDS: a multicenter randomized trial"],"prefix":"10.3389","volume":"14","author":[{"given":"Jin","family":"Gao","sequence":"first","affiliation":[{"name":"Department of Neonatology, National Clinical Research Center for Children and Adolescents' Health and Diseases, Ministry of Education Key Laboratory of Child Development and Disorders, Children's Hospital of Chongqing Medical University","place":["Chongqing, China"]},{"name":"Key Laboratory of Child Rare Diseases in Infection and Immunity, Children's Hospital of Chongqing Medical University","place":["Chongqing, China"]},{"name":"Department of Neonatology, Kunming Children\u2019s Hospital","place":["Kunming, Yunnan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanmei","family":"Xiong","sequence":"additional","affiliation":[{"name":"Department of Neonatology, The First People\u2019s Hospital of Zhaotong","place":["Zhaotong, Yunnan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chuanfeng","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Qujing Maternity and Child Healthcare Hospital","place":["Qujing, Yunnan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weihong","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Neonatology, The People\u2019s Hospital of Wenshan Prefecture","place":["Wenshan, Yunnan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Yuxi Children\u2019s Hospital","place":["Yuxi, Yunnan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Panrong","family":"Nie","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Baoshan People\u2019s Hospital","place":["Baoshan, Yunnan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lingyun","family":"Bao","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Kunming Children\u2019s Hospital","place":["Kunming, Yunnan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Qujing Maternity and Child Healthcare Hospital","place":["Qujing, Yunnan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuan","family":"Shi","sequence":"additional","affiliation":[{"name":"Department of Neonatology, National Clinical Research Center for Children and Adolescents' Health and Diseases, Ministry of Education Key Laboratory of Child Development and Disorders, Children's Hospital of Chongqing Medical University","place":["Chongqing, China"]},{"name":"Key Laboratory of Child Rare Diseases in Infection and Immunity, Children's Hospital of Chongqing Medical 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