Ayala Gover, Tatiana Smolkin, Michal Molad, Karen Lavie-Nevo, Adir Iofe, Rasha Zoabi-Safadi, Arina Toropine, Rawnak Nazem Saab, Dan Waisman, Avi Rotschild, Amir Kugelman, Arieh Riskin
{"title":"早产儿HHHFNC与长窄插管NIPPV：随机非劣效性试验。","authors":"Ayala Gover, Tatiana Smolkin, Michal Molad, Karen Lavie-Nevo, Adir Iofe, Rasha Zoabi-Safadi, Arina Toropine, Rawnak Nazem Saab, Dan Waisman, Avi Rotschild, Amir Kugelman, Arieh Riskin","doi":"10.1002/ppul.71167","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Heated humidified high flow (HHHFNC) and nasal intermittent positive pressure ventilation (NIPPV) delivered by cannula with long and narrow tubing (CLNT) are increasingly used in preterm infants for providing noninvasive respiratory support, due to their high comfort level and minimal nasal trauma. Despite their widespread use, no randomized controlled trial has been conducted so far.</p><p><strong>Objective: </strong>Determine whether HHHFNC is non-inferior to CLNT-NIPPV in providing respiratory support for preterm infants.</p><p><strong>Study design: </strong>An unblinded, randomized controlled, non-inferiority multicenter trial.</p><p><strong>Methodology: </strong>Preterm infants randomized to either HHHFNC or CLNT-NIPPV. Infants born > 28 weeks of gestation were eligible to enter the study either as primary treatment after birth or post-extubation. Infants born ≤ 28 weeks of gestation were only eligible post-extubation. The primary outcome was treatment failure within 7 days.</p><p><strong>Results: </strong>One hundred and thirty infants were enrolled in the study; 65 in each group. Most (82%) were > 28 weeks, and primary treatment (73%). HHHFNC was non-inferior to CLNT-NIPPV in the primary outcome which occurred in 12.3% compared to 23.0% of the infants, respectively (risk difference (RD) -10.77%, 95% CI of RD -23.7 to 2.22 [within the non-inferiority margin], χ<sup>2</sup>p = 0.168). HHHFNC was associated with significantly less nasal trauma compared to CLNT-NIPPV but with longer time on the allocated respiratory support. No significant differences were found between the groups in secondary respiratory and neonatal outcomes.</p><p><strong>Conclusions: </strong>In this study of preterm infants mostly > 28 weeks of gestation, HHHFNC was non-inferior to CLNT-NIPPV in providing respiratory support, and caused less nasal trauma.</p>","PeriodicalId":19932,"journal":{"name":"Pediatric Pulmonology","volume":"60 6","pages":"e71167"},"PeriodicalIF":2.7000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12172398/pdf/","citationCount":"0","resultStr":"{\"title\":\"HHHFNC Versus NIPPV Delivered by Long Narrow Cannula in Preterm Infants: Randomized Noninferiority Trial.\",\"authors\":\"Ayala Gover, Tatiana Smolkin, Michal Molad, Karen Lavie-Nevo, Adir Iofe, Rasha Zoabi-Safadi, Arina Toropine, Rawnak Nazem Saab, Dan Waisman, Avi Rotschild, Amir Kugelman, Arieh Riskin\",\"doi\":\"10.1002/ppul.71167\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Heated humidified high flow (HHHFNC) and nasal intermittent positive pressure ventilation (NIPPV) delivered by cannula with long and narrow tubing (CLNT) are increasingly used in preterm infants for providing noninvasive respiratory support, due to their high comfort level and minimal nasal trauma. Despite their widespread use, no randomized controlled trial has been conducted so far.</p><p><strong>Objective: </strong>Determine whether HHHFNC is non-inferior to CLNT-NIPPV in providing respiratory support for preterm infants.</p><p><strong>Study design: </strong>An unblinded, randomized controlled, non-inferiority multicenter trial.</p><p><strong>Methodology: </strong>Preterm infants randomized to either HHHFNC or CLNT-NIPPV. Infants born > 28 weeks of gestation were eligible to enter the study either as primary treatment after birth or post-extubation. Infants born ≤ 28 weeks of gestation were only eligible post-extubation. The primary outcome was treatment failure within 7 days.</p><p><strong>Results: </strong>One hundred and thirty infants were enrolled in the study; 65 in each group. Most (82%) were > 28 weeks, and primary treatment (73%). HHHFNC was non-inferior to CLNT-NIPPV in the primary outcome which occurred in 12.3% compared to 23.0% of the infants, respectively (risk difference (RD) -10.77%, 95% CI of RD -23.7 to 2.22 [within the non-inferiority margin], χ<sup>2</sup>p = 0.168). HHHFNC was associated with significantly less nasal trauma compared to CLNT-NIPPV but with longer time on the allocated respiratory support. No significant differences were found between the groups in secondary respiratory and neonatal outcomes.</p><p><strong>Conclusions: </strong>In this study of preterm infants mostly > 28 weeks of gestation, HHHFNC was non-inferior to CLNT-NIPPV in providing respiratory support, and caused less nasal trauma.</p>\",\"PeriodicalId\":19932,\"journal\":{\"name\":\"Pediatric Pulmonology\",\"volume\":\"60 6\",\"pages\":\"e71167\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12172398/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pediatric Pulmonology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/ppul.71167\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PEDIATRICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Pulmonology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/ppul.71167","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}
HHHFNC Versus NIPPV Delivered by Long Narrow Cannula in Preterm Infants: Randomized Noninferiority Trial.
Background: Heated humidified high flow (HHHFNC) and nasal intermittent positive pressure ventilation (NIPPV) delivered by cannula with long and narrow tubing (CLNT) are increasingly used in preterm infants for providing noninvasive respiratory support, due to their high comfort level and minimal nasal trauma. Despite their widespread use, no randomized controlled trial has been conducted so far.
Objective: Determine whether HHHFNC is non-inferior to CLNT-NIPPV in providing respiratory support for preterm infants.
Study design: An unblinded, randomized controlled, non-inferiority multicenter trial.
Methodology: Preterm infants randomized to either HHHFNC or CLNT-NIPPV. Infants born > 28 weeks of gestation were eligible to enter the study either as primary treatment after birth or post-extubation. Infants born ≤ 28 weeks of gestation were only eligible post-extubation. The primary outcome was treatment failure within 7 days.
Results: One hundred and thirty infants were enrolled in the study; 65 in each group. Most (82%) were > 28 weeks, and primary treatment (73%). HHHFNC was non-inferior to CLNT-NIPPV in the primary outcome which occurred in 12.3% compared to 23.0% of the infants, respectively (risk difference (RD) -10.77%, 95% CI of RD -23.7 to 2.22 [within the non-inferiority margin], χ2p = 0.168). HHHFNC was associated with significantly less nasal trauma compared to CLNT-NIPPV but with longer time on the allocated respiratory support. No significant differences were found between the groups in secondary respiratory and neonatal outcomes.
Conclusions: In this study of preterm infants mostly > 28 weeks of gestation, HHHFNC was non-inferior to CLNT-NIPPV in providing respiratory support, and caused less nasal trauma.
期刊介绍：
Pediatric Pulmonology (PPUL) is the foremost global journal studying the respiratory system in disease and in health as it develops from intrauterine life though adolescence to adulthood. Combining explicit and informative analysis of clinical as well as basic scientific research, PPUL provides a look at the many facets of respiratory system disorders in infants and children, ranging from pathological anatomy, developmental issues, and pathophysiology to infectious disease, asthma, cystic fibrosis, and airborne toxins. Focused attention is given to the reporting of diagnostic and therapeutic methods for neonates, preschool children, and adolescents, the enduring effects of childhood respiratory diseases, and newly described infectious diseases.
PPUL concentrates on subject matters of crucial interest to specialists preparing for the Pediatric Subspecialty Examinations in the United States and other countries. With its attentive coverage and extensive clinical data, this journal is a principle source for pediatricians in practice and in training and a must have for all pediatric pulmonologists.
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