Harshit Kumar, Suksham Jain, Deepak Chawla, Supreet Khurana, Kiran Prakash, Abhishek Yadav, Yaseer Ahmad Mir
{"title":"t件式复苏器与自动充气袋在产房中用于早产儿复苏：一项随机对照试验。","authors":"Harshit Kumar, Suksham Jain, Deepak Chawla, Supreet Khurana, Kiran Prakash, Abhishek Yadav, Yaseer Ahmad Mir","doi":"10.1136/archdischild-2024-327875","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To compare the efficacy of T-piece resuscitator (TPR) and self-inflating bag (SIB) for resuscitation of preterm neonates in the delivery room.</p><p><strong>Settings: </strong>Level III neonatal intensive care unit in North India.</p><p><strong>Design: </strong>Open-label, parallel-group, randomised controlled trial.</p><p><strong>Patient: </strong>Preterm neonates of>26-34 weeks of gestation requiring positive pressure ventilation (PPV) at birth.</p><p><strong>Intervention: </strong>Neonates needing PPV at birth were identified using Neonatal Resuscitation Programme guidelines, 2020, and resuscitated using either TPR or SIB as per permuted block random sequence.</p><p><strong>Main outcome measures: </strong>Primary outcome was need for delivery room endotracheal intubation. Secondary outcomes were duration of PPV, oxygen saturation (SpO2) at 2 and 5 min, time to spontaneous respiration and heart rate>100 beats per minute.</p><p><strong>Results: </strong>Mean gestation age (weeks; 30±2.1 vs 31±2) and birth weight (g; 1400±408 vs 1450±427) were comparable. Of the total 120, 8 (13.7%) in the TPR group versus 19 (30.6%) neonates in the SIB group were intubated in the delivery room (risk difference (95% CI), -0.16 (-0.31 to -0.02); p=0.03). SpO2 mean (SD) at 5 min in TPR group and SIB group were 82.9±8.7% and 78.9±12.1%, respectively; mean difference (95% CI), 3.99 (0.15 to 7.83); p=0.04). Median (IQR) of combined Apgar at 5 min in TPR group and SIB group were 13 (12-14) and 12 (10-13), p 0.02. Other outcomes were comparable.</p><p><strong>Conclusion: </strong>TPR is more efficacious than SIB in terms of lesser delivery room intubation and better SpO2 at 5 min in preterm neonates.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.9000,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"T-piece resuscitator versus self-inflating bag for resuscitation in the delivery room in preterm neonates: a randomised controlled trial.\",\"authors\":\"Harshit Kumar, Suksham Jain, Deepak Chawla, Supreet Khurana, Kiran Prakash, Abhishek Yadav, Yaseer Ahmad Mir\",\"doi\":\"10.1136/archdischild-2024-327875\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To compare the efficacy of T-piece resuscitator (TPR) and self-inflating bag (SIB) for resuscitation of preterm neonates in the delivery room.</p><p><strong>Settings: </strong>Level III neonatal intensive care unit in North India.</p><p><strong>Design: </strong>Open-label, parallel-group, randomised controlled trial.</p><p><strong>Patient: </strong>Preterm neonates of>26-34 weeks of gestation requiring positive pressure ventilation (PPV) at birth.</p><p><strong>Intervention: </strong>Neonates needing PPV at birth were identified using Neonatal Resuscitation Programme guidelines, 2020, and resuscitated using either TPR or SIB as per permuted block random sequence.</p><p><strong>Main outcome measures: </strong>Primary outcome was need for delivery room endotracheal intubation. Secondary outcomes were duration of PPV, oxygen saturation (SpO2) at 2 and 5 min, time to spontaneous respiration and heart rate>100 beats per minute.</p><p><strong>Results: </strong>Mean gestation age (weeks; 30±2.1 vs 31±2) and birth weight (g; 1400±408 vs 1450±427) were comparable. Of the total 120, 8 (13.7%) in the TPR group versus 19 (30.6%) neonates in the SIB group were intubated in the delivery room (risk difference (95% CI), -0.16 (-0.31 to -0.02); p=0.03). SpO2 mean (SD) at 5 min in TPR group and SIB group were 82.9±8.7% and 78.9±12.1%, respectively; mean difference (95% CI), 3.99 (0.15 to 7.83); p=0.04). Median (IQR) of combined Apgar at 5 min in TPR group and SIB group were 13 (12-14) and 12 (10-13), p 0.02. 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引用次数: 0
摘要
目的：比较t片式复苏器（TPR）与自充气袋（SIB）在产房早产儿复苏中的应用效果。环境：印度北部三级新生儿重症监护病房。设计：开放标签、平行组、随机对照试验。患者：出生时需要正压通气（PPV）的26 ~ 34周的早产儿。干预措施：根据2020年新生儿复苏计划指南确定出生时需要PPV的新生儿，并按照排列块随机顺序使用TPR或SIB进行复苏。主要观察指标：主要观察指标为产房气管插管需求。次要结果为PPV持续时间、2 min和5 min血氧饱和度（SpO2）、自主呼吸时间和心率bbb100次/分钟。结果：平均胎龄（周）；30±2.1 vs 31±2)和出生体重(g；1400±408 vs 1450±427)具有可比性。在总共120例新生儿中，TPR组8例（13.7%）新生儿在产房插管，SIB组19例（30.6%）新生儿在产房插管(风险差异（95% CI）， -0.16(-0.31至-0.02)；p = 0.03)。TPR组和SIB组5 min时SpO2均值（SD）分别为82.9±8.7%和78.9±12.1%；平均差异（95% CI）， 3.99 (0.15 ~ 7.83)；p = 0.04)。TPR组和SIB组5 min联合Apgar的中位数（IQR）分别为13（12-14）和12 (10-13),p < 0.02。其他结果具有可比性。结论：TPR比SIB在减少产房插管和改善5 min SpO2方面更有效。
T-piece resuscitator versus self-inflating bag for resuscitation in the delivery room in preterm neonates: a randomised controlled trial.
Objective: To compare the efficacy of T-piece resuscitator (TPR) and self-inflating bag (SIB) for resuscitation of preterm neonates in the delivery room.
Settings: Level III neonatal intensive care unit in North India.
Patient: Preterm neonates of>26-34 weeks of gestation requiring positive pressure ventilation (PPV) at birth.
Intervention: Neonates needing PPV at birth were identified using Neonatal Resuscitation Programme guidelines, 2020, and resuscitated using either TPR or SIB as per permuted block random sequence.
Main outcome measures: Primary outcome was need for delivery room endotracheal intubation. Secondary outcomes were duration of PPV, oxygen saturation (SpO2) at 2 and 5 min, time to spontaneous respiration and heart rate>100 beats per minute.
Results: Mean gestation age (weeks; 30±2.1 vs 31±2) and birth weight (g; 1400±408 vs 1450±427) were comparable. Of the total 120, 8 (13.7%) in the TPR group versus 19 (30.6%) neonates in the SIB group were intubated in the delivery room (risk difference (95% CI), -0.16 (-0.31 to -0.02); p=0.03). SpO2 mean (SD) at 5 min in TPR group and SIB group were 82.9±8.7% and 78.9±12.1%, respectively; mean difference (95% CI), 3.99 (0.15 to 7.83); p=0.04). Median (IQR) of combined Apgar at 5 min in TPR group and SIB group were 13 (12-14) and 12 (10-13), p 0.02. Other outcomes were comparable.
Conclusion: TPR is more efficacious than SIB in terms of lesser delivery room intubation and better SpO2 at 5 min in preterm neonates.
期刊介绍：
Archives of Disease in Childhood is an international peer review journal that aims to keep paediatricians and others up to date with advances in the diagnosis and treatment of childhood diseases as well as advocacy issues such as child protection. It focuses on all aspects of child health and disease from the perinatal period (in the Fetal and Neonatal edition) through to adolescence. ADC includes original research reports, commentaries, reviews of clinical and policy issues, and evidence reports. Areas covered include: community child health, public health, epidemiology, acute paediatrics, advocacy, and ethics.
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