ChiCTR2300069595 版本V1.0 版本创建时间2023/03/21 16:18:29 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2300069595 

最近更新日期：

Date of Last Refreshed on：

2023-03-21 16:18:24 

注册时间：

Date of Registration：

2023-03-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

俯卧位预防早产儿呼吸暂停的疗效观察

Public title：

Effect of prone position on prevention of apnea in premature infants

注册题目简写：

俯卧位预防早产儿呼吸暂停的疗效观察

English Acronym：

Effect of prone position on prevention of apnea in premature infants

研究课题的正式科学名称：

俯卧位预防早产儿呼吸暂停的疗效观察

Scientific title：

Effect of prone position on prevention of apnea in premature infants

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

柳俊伶 

研究负责人：

柳俊伶 

Applicant：

Liu junling 

Study leader：

Liu junling 

申请注册联系人电话：

Applicant telephone：

+86 13466082916

研究负责人电话：

Study leader's telephone：

+86 13466082916

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

13577403337@163.com

研究负责人电子邮件：

Study leader's E-mail：

13577403337@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

云南省曲靖市麒麟区寥廓南路371号

研究负责人通讯地址：

云南省曲靖市麒麟区寥廓南路371号

Applicant address：

No. 371, Guiguo South Road, Qilin District, Qujing City, Yunnan Province

Study leader's address：

No. 371, Guiguo South Road, Qilin District, Qujing City, Yunnan Province

申请注册联系人邮政编码：

Applicant postcode：

0874-655000

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

曲靖市妇幼保健院寥廓院区

Applicant's institution：

Qujing Women's and Children's Health Care Hospital area

研究负责人所在单位：

曲靖市妇幼保健院寥廓院区

Affiliation of the Leader：

Qujing Women's and Children's Health Care Hospital area

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

QJFYLL2023-KY016

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

曲靖市妇幼保健院医学伦理委员

Name of the ethic committee：

Committee member of Medical Ethics, Qujing Maternal and Child Health Care Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2022-12-20 00:00:00

伦理委员会联系人：

段秀

Contact Name of the ethic committee：

Duan xiu

伦理委员会联系地址：

云南省曲靖市麒麟区珠江源大道南延线

Contact Address of the ethic committee：

South extension Line of Zhujiang Yuan Avenue, Qilin District, Qujing City, Yunnan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

曲靖市妇幼保健院寥廓院区

Primary sponsor：

Qujing Women's and Children's Health Care Hospital area

研究实施负责（组长）单位地址：

云南省曲靖市麒麟区寥廓南路371号

Primary sponsor's address：

No. 371, Guiguo South Road, Qilin District, Qujing City, Yunnan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

云南省

市(区县)：

曲靖市

Country：

China

Province：

Yunnan

City：

Qujing

单位(医院)：

曲靖市妇幼保健院

具体地址：

云南省曲靖市麒麟区珠江源大道南延线

Institution
hospital：

Qujing Women's and Children's Health Care Hospital area

Address：

South Extension Line of Zhujiangyuan Avenue, Qilin District, Qujing, Yunnan

经费或物资来源：

院内科研：15000元

Source(s) of funding：

$15,000 for in-school projects

Target disease：

apnea of prematurity

Target disease code：

AOP

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

据统计我国早产儿每年出生数量接近117万,位于世界第二位[1] 。提高早产儿护理质量有利于改善其预后，提高早产儿存活率，降低并发症。在国内外研究中，重视早产儿体位管理，体位如果不适宜，可能会加重病情，出现一些严重的并发症，其中俯卧位通气越来越受到重视。我省云南位于西南片区，毗邻边境地区，经济欠发达，尤其医疗技术水平参差不齐，治疗方案不统一，加上三孩政策全面开放，高龄产妇明显增加，早产儿出生数量增加，早产儿呼吸中枢不成熟，其中早产儿呼吸暂停(Apnea Of Prematurity，AOP) 是一种严重的现象，是引起新生儿猝死的原因之一，若不及时处理，长时间缺氧可造成脑损害及其他后遗症。做到整个云南省包括地州县医院规范技术，规范治疗方案，并应用于新生儿NICU治疗中，俯卧位是一种简单、实用、有效的干预措施。本研究项目俯卧位通气成为了最符合上述研究要求，具有重大研究价值。 俯卧位对于早产儿呼吸暂停适用性很高，首创开展三阶梯卧位来改善俯卧位通气临床疗效。  

Objectives of Study：

According to statistics, the number of premature babies born in China is nearly 1.17 million every year, ranking second in the world [1]. Improving the nursing quality of premature infants is beneficial to improve the prognosis, increase the survival rate of premature infants and reduce complications. In domestic and foreign studies, attention has been paid to the position management of premature infants. If the position is not suitable, it may aggravate the condition and cause some serious complications. Prone position ventilation has been paid more and more attention. Yunnan Province is located in the southwest region, adjacent to the border area, the economy is underdeveloped, especially the level Of medical technology is uneven, the treatment plan is not unified, plus the three-child policy is fully open, the number of elderly paraplegia increased significantly, the number of premature babies born increased, the respiratory center of premature infants is immature, among which, Apnea Of Prematurity, Apnea of prematurity, AOP is a serious phenomenon, is one of the causes of sudden neonatal death, if not timely treatment, prolonged hypoxia can cause brain damage and other sequelae. To standardize the technique and treatment plan in the whole Yunnan Province, including Dizhou County hospitals, and apply it in neonatal NICU treatment, prone position is a simple, practical and effective intervention measure. Prone position ventilation in this research project is the most consistent with the above research requirements and has great research value. In domestic and foreign studies, attention has been paid to the position management of premature infants. If the position is not suitable, it may aggravate the condition and cause some serious complications. Prone position ventilation has been paid more and more attention.

药物成份或治疗方案详述：

1、选取2023年1月-2024年12月期间在我院产科出生或外院出生因新生儿的100名新生儿为研究对象，征得研究对象监护人的知情同意及并签署知情同意书，通过医院伦理委员会批准，以询问病史的形式收集新生儿出生时间、出生体重、性别、胎龄、喂养方式、有无窒息史、父母年龄、孕产次、母亲孕前体质指数、母亲吸烟、酗酒情况等。明确是否有早产儿呼吸暂停的相关疾病(原发性呼吸中枢发育不成熟，缺氧，感染，中枢神经系统疾病、周围环境温度不适宜，代谢紊乱，出现胃食管反流，颈部解剖异常)。纳入标准：①经医院伦理委员会批准及患儿家属知情同意; ②早产儿胎龄≤34 周，体重小于2kg, 在新生儿期日龄 1h ～ 7d; ③出生后 48 h 内发生呼吸暂停; ④1 h 内呼吸暂停反复发作不超过 3 次; 早产儿呼吸暂停诊断标准根据《早产儿呼吸暂停诊治专家共识》（中华儿科杂志，2022，60（7）：627-632）：早产儿发生呼吸中断≥20 s，或<20 s伴有心率下降或血氧饱和度下降。 2、研究对象排除标准：不愿参与研究及不配合随访的家长；神经肌肉疾病如围生期窒息、颅内出血、颅内感染、脑积水、惊厥、先天性肌病或神经疾病；呼吸系统疾病如低氧血症、高碳酸血症、气道阻塞、膈或声带麻痹、气胸、肺出血、肺部感染；消化系统疾病如喂养不耐受、新生儿坏死性小肠结肠炎、腹膜炎；心血管系统疾病如心力衰竭、血流动力学异常的动脉导管未闭、严重先天性心脏病、严重血容量不足、低血压、高血压；血液系统疾病如贫血、红细胞增多症、严重高胆红素血症；代谢及电解质紊乱如低血糖、高氨血症、甲状腺功能低下、低钠、高钠、高镁、高钾血症；其他如严重感染、体温不稳定、母亲用麻醉药及硫酸镁、迷走神经反射（插胃管、颈部过度屈曲及伸展）。 3、纳入研究的患儿均置于暖箱（型号：YP-90，YP-90B）的鸟巢中，用床旁角度仪，给予床旁心电监测、血氧饱和度监测及早产儿常规生活护理; 两组均采用床旁心电监护仪（型号:迈瑞ipm8，迈瑞PM8000,迈瑞PM9000）24 h 监护，设置呼吸暂停报警，呼吸－新生儿心肺监护仪通常设置为呼吸停止≥15或20秒时报警。心率－早产儿心肺监护仪通常设置为心率≤70或80次/分时报警。脉搏血氧测定－通常设置为氧饱和度<85%或80%时报警。保持环境湿度为 55%～65%，室温为 24℃～26℃，使早产儿体温稳定在36.5~37.0 ℃，予以静脉营养及早产儿喂养，维持水电解质平衡，两组研究对象呼吸暂停发作次数无统计学差异，均不使用咖啡因药物、NCPAP及呼吸机等治疗，若频繁呼吸暂停危及生命时，遵循医学伦理要求，予剔除研究组并对进行药物等积极治疗。 4.通过电脑软件将纳入研究患儿随机分配分为观察组及对照组，观察组及对照组均符合以下纳入标准：日龄1周内，胎龄为29～34 周 ，男女婴数量间无统计学差异，体重 1.0～2.0 kg，呼吸暂停一小时发作少于3次，发作时无严重缺氧，弹足底/托背刺激能恢复自主呼吸，诊断为原发性呼吸暂停，试验期间未查出导致呼吸暂停的继发病因；两组进行双盲随机对照试验； 5.观察组呼吸暂停的采取俯卧位置于暖箱中，头抬高0°、 15°、30°，偏向左或右治疗，四肢自然摆放呈蛙状，左右交替，保证每天患儿俯卧时间≥18 h，每隔 6h 进行一次床头抬高位更换。依次按照以下体位及头抬高位分为3亚组：0°俯卧位、15°俯卧位、30°俯卧位、分别记录生命体征，呼吸暂停发作次数，清醒时间、睡眠时间。对照组选择仰卧位的护理方法，头抬高0°，把患儿头偏向一侧，四肢自然垂放，左右两侧交替，保证每隔 6 h 进行一次体位更换，保证颈下无任何支撑物，同时每天仰卧时间≥18 h。记录两组每个喂奶周期的清醒时间、睡眠时间。除治疗、喂奶、皮肤护理等时间外，均保持相应体位。将所有数据由双人核对后输入电脑存储。 6、生命体征监测时间：持续一周，每天在摆放不同体位及不同角度时，监测早产儿在每个体位下的生命体征(包括心率(Heart rate,HR)、呼吸(Respiratoryrate,RR)、经皮脉搏血氧饱和度(Percutaneous pulse oxygen saturation,SpO2)，并做好记录。在应用床旁监护仪时，通过血氧探头连接予患儿手掌处或任意一足底进行监测（动脉导管后部位），心电监护仪屏幕可以监测到患儿 HR、SpO2，且应在每个喂奶周期更换探头位置，免压伤皮肤。床旁心电监护时应避免血氧探头脱落及接触不良（哭闹、做治疗、检查、操作时）均应检查血氧探头仪是否连接于患儿，避免心电监护结果不准确，正确设置报警界限，不允许关闭心电监护的报警系统，同时观察心电信号，呼吸波，心率及呼吸频率，血氧饱和度情况，记录早产儿清醒、睡眠情况：每天在摆放不同体位及不同角度时，记录早产儿每天在每个喂奶周期内不同体位及不同角度下的清醒时间和睡眠时间。 7、2023年1月～2月邀请课题相关人员，召开课题会议，介绍上述1-6具体方案及细节，测量前校准各试验用仪器，并且在摆放每个体位前，同时运用两种床头角度仪对抬高角度进行测量，以提高床头抬高角度测量的准确性。在试验前，对所有操作人员进行了相关技术操作培训。 8、整理数据资料，妊娠和临床数据(胎龄、出生体重、体长、头围、胸围、腹围以及1分钟和5分钟Apgar评分)绘制成医学图表并输入电脑。数据资料进行统计学分析，所有数据由双人核对后，录入 SPSS 22.0 统计软件，然后进行统计学分析。其中，定量资料用 t 检验，定性资料用卡方检验，并且将仰卧位与俯卧位、床头抬高 15°各值，进行成组设计的 t 检验，以 P<0.05，表示差异有统计学意义。使用Kolmogorov-Smirnov检验验证了连续数据的正态分布。对非正态分布的连续数据进行了对数变换，以不影响其分布。定性资料采用卡方检验，连续变量采用重复测量方差分析。P<0.05被认为具有统计学意义。 

Description for medicine or protocol of treatment in detail：

1. 100 newborns born in the obstetrics department of our hospital or in other hospitals from January 2023 to December 2024 were selected as the research objects. Informed consent and signed informed consent were obtained from the guardians of the subjects and approved by the Ethics Committee of the hospital. Birth time, birth weight, gender, gestational age, feeding pattern, asphyxia history, parental age, gestational number, pre-pregnancy body mass index of the mother, smoking and alcoholism of the mother were collected in the form of medical history inquiry. Identify any preterm apnea related diseases (primary respiratory center immature development, hypoxia, infection, central nervous system disease, ambient temperature inappropriate, metabolic disorders, gastroesophageal reflux, neck anatomical abnormalities). Inclusion criteria: ① Approved by the hospital ethics committee and informed consent of the child's family; ② Gestational age of preterm infants ≤34 weeks, body weight less than 2kg, 1h ~ 7d in neonatal period; ③ Apnea occurs within 48 hours after birth; ④ Recurrent apnea does not occur more than 3 times within 1 h; Diagnostic criteria for premature apnea According to Expert Consensus on the diagnosis and treatment of premature apnea (Chinese Journal of Pediatrics, 2022, 60 (7) : 627-632) : Respiratory interruption occurred in premature infants ≥20 s, or s accompanied by decreased heart rate or oxygen saturation. 2. Exclusion criteria for subjects: parents who did not want to participate in the study and did not cooperate with follow-up; Neuromuscular diseases such as perinatal asphyxia, intracranial hemorrhage, intracranial infection, hydrocephalus, convulsion, congenital myopathy, or neurological diseases; Respiratory diseases such as hypoxemia, hypercapnia, airway obstruction, paralysis of diaphragm or vocal cord, pneumothorax, pulmonary hemorrhage, lung infection; Digestive diseases such as feeding intolerance, neonatal necrotizing enterocolitis, peritonitis; Cardiovascular diseases such as heart failure, hemodynamic abnormalities of patent ductus arteriosus, severe congenital heart disease, severe hypovolemia, hypotension, hypertension; Hematological diseases such as anemia, polycythemia, severe hyperbilirubinemia; Metabolic and electrolyte disorders such as hypoglycemia, hyperaminemia, hypothyroidism, hyposodium, hypersodium, hypermagnesium, hyperkalemia; Others include severe infection, temperature instability, maternal anesthetics and magnesium sulfate, vagal reflex (gastric tube insertion, excessive neck flexion and extension). 3. All the children included in the study were placed in the nest of warm box (model: YP-90, YP-90B), and were given bedside ECG monitoring, blood oxygen saturation monitoring and routine nursing of premature infants with bedside Angle instrument; Both groups were monitored by bedside electrocardiograph (model: Mindray ipm8, Mindray PM8000, Mindray PM9000) for 24 hours, and apnea alarm was set. Respiratory - newborn cardiopulmonary monitor was usually set to alarm when respiratory arrest ≥15 or 20 seconds. Heart rate - Premature infants cardiopulmonary monitor is usually set to heart rate ≤70 or 80 beats/time alarm. Pulse oximetry - Alarm is usually set to oxygen saturation or 80%. The ambient humidity was kept at 55%-65%, the room temperature was kept at 24℃ ~ 26℃, and the temperature of preterm infants was kept at 36.5~37.0 ℃. Intravenous nutrition and feeding of preterm infants were provided to maintain water and electrolyte balance. There was no statistical difference in the number of apnea attacks between the two groups. If frequent apnea is life-threatening, the study group should be excluded and active treatment such as medication should be given in accordance with medical ethical requirements. 4. The children included in the study were randomly assigned to the observation group and the control group by computer software, both of which met the following inclusion criteria: Within one week of age, the gestational age was 29 to 34 weeks, there was no statistical difference between the number of male and female, the weight was 1.0 to 2.0 kg, apnea had less than 3 attacks within one hour, no severe hypoxia at the time of attack, plantar/back support stimulation could restore spontaneous respiration, diagnosed as primary apnea, no secondary cause of apnea was found during the test. A double-blind randomized controlled trial was conducted in both groups. 5. In the observation group, apnea was taken prone position in the warm box, head elevation 0°, 15°, 30°, left or right treatment, limbs naturally placed in the shape of a frog, left and right alternating, to ensure that the children's prone lying time ≥18 h every day, every 6 hours to replace the head elevation. They were divided into 3 subgroups according to the following body positions and head elevation: 0° prone position, 15° prone position and 30° prone position. Vital signs, apnea episodes, awake time and sleep time were recorded respectively. Control group choose supine position nursing method, head elevation 0°, the children's head to one side, limbs natural hanging, alternating on both sides, to ensure that every 6 hours for a replacement of the position, to ensure that there is no support under the neck, at the same time every day supine time ≥18 h. The awake time and sleep time of each feeding cycle were recorded in the two groups. Maintain appropriate postures except for treatment, nursing and skin care. All data is checked by two people and entered into the computer for storage. 6. Monitoring time of vital signs: Every day for a week, in different positions and at different angles, Vital signs (including Heart rate (HR), Respiratoryrate (RR) and Percutaneous pulse oxygen saturation (SpO2) of preterm infants at each position were monitored and recorded. When the bedside monitor is applied, the blood oxygen probe is connected to the palm of the child or any sole of the foot for monitoring (posterior to the arterial catheter). The ECG monitor screen can monitor the HR and SpO2 of the child, and the probe position should be changed during each feeding cycle to avoid pressure injury to the skin. During bedside ECG monitoring, it is necessary to avoid the loss and poor contact of the oxygen probe (crying, treatment, examination and operation). It is necessary to check whether the oxygen probe is connected to the children, avoid inaccurate ECG monitoring results, set alarm limits correctly, and do not allow to close the alarm system of the ECG monitoring. At the same time, observe the ECG signal, respiratory wave, heart rate and respiratory rate, and blood oxygen saturation. The waking and sleeping conditions of premature infants were recorded: the waking time and sleeping time of premature infants under different positions and angles in each feeding cycle were recorded every day when different positions and angles were placed. 7. From January to February 2023, relevant personnel of the project were invited to hold a project meeting to introduce the specific program and details of 1-6 mentioned above. Before measurement, calibration of each test instrument was conducted, and two kinds of bedside Angle instrument were used to measure elevation Angle before placing each position, so as to improve the accuracy of measurement of bedside elevation Angle. Before the test, all operators were trained in relevant technical operations. 8. Sorted out the data, and drew medical charts of pregnancy and clinical data (gestational age, birth weight, body length, head circumference, chest circumference, abdominal circumference and 1-minute and 5-minute Apgar score) and input them into the computer. All data were checked by two persons and input into SPSS 22.0 statistical software for statistical analysis. Among them, quantitative data were tested by t test, qualitative data by chi-square test, and the values of supine position, prone position and head of bed were raised by 15°, and the group design of t test was conducted. Pindicated that the difference was statistically significant. Kolmogorov-Smirnov test was used to verify the normal distribution of continuous data. Logarithmic transformation is performed on the non-normally distributed continuous data so as not to affect its distribution. Chi-square test was used for qualitative data and repeated measurement analysis of variance was used for continuous variables. Pwas considered statistically significant. 

纳入标准：

纳入标准：①经医院伦理委员会批准及患儿家属知情同意; ②早产儿胎龄≤34 周，体重小于2kg, 在新生儿期日龄 1h ～ 7d; ③出生后 48 h 内发生呼吸暂停; ④1 h 内呼吸暂停反复发作不超过 3 次; 早产儿呼吸暂停诊断标准根据《早产儿呼吸暂停诊治专家共识》（中华儿科杂志，2022，60（7）：627-632）：早产儿发生呼吸中断≥20 s，或<20 s伴有心率下降或血氧饱和度下降。

Inclusion criteria

Inclusion criteria: ① Approved by the hospital ethics committee and informed consent of the child's family; ② Gestational age of preterm infants ≤34 weeks, body weight less than 2kg, 1h ~ 7d in neonatal period; ③ Apnea occurs within 48 hours after birth; ④ Recurrent apnea does not occur more than 3 times within 1 h; Diagnostic criteria for premature apnea According to Expert Consensus on the diagnosis and treatment of premature apnea (Chinese Journal of Pediatrics, 2022, 60 (7) : 627-632) : Respiratory interruption occurred in premature infants ≥20 s, or s accompanied by decreased heart rate or oxygen saturation.

排除标准：

：不愿参与研究及不配合随访的家长；神经肌肉疾病如围生期窒息、颅内出血、颅内感染、脑积水、惊厥、先天性肌病或神经疾病；呼吸系统疾病如低氧血症、高碳酸血症、气道阻塞、膈或声带麻痹、气胸、肺出血、肺部感染；消化系统疾病如喂养不耐受、新生儿坏死性小肠结肠炎、腹膜炎；心血管系统疾病如心力衰竭、血流动力学异常的动脉导管未闭、严重先天性心脏病、严重血容量不足、低血压、高血压；血液系统疾病如贫血、红细胞增多症、严重高胆红素血症；代谢及电解质紊乱如低血糖、高氨血症、甲状腺功能低下、低钠、高钠、高镁、高钾血症；其他如严重感染、体温不稳定、母亲用麻醉药及硫酸镁、迷走神经反射（插胃管、颈部过度屈曲及伸展）。

Exclusion criteria：

: Parents who did not want to participate in the study and did not cooperate with follow-up visits; Neuromuscular diseases such as perinatal asphyxia, intracranial hemorrhage, intracranial infection, hydrocephalus, convulsion, congenital myopathy, or neurological diseases; Respiratory diseases such as hypoxemia, hypercapnia, airway obstruction, paralysis of diaphragm or vocal cord, pneumothorax, pulmonary hemorrhage, lung infection; Digestive diseases such as feeding intolerance, neonatal necrotizing enterocolitis, peritonitis; Cardiovascular diseases such as heart failure, hemodynamic abnormalities of patent ductus arteriosus, severe congenital heart disease, severe hypovolemia, hypotension, hypertension; Hematological diseases such as anemia, polycythemia, severe hyperbilirubinemia; Metabolic and electrolyte disorders such as hypoglycemia, hyperaminemia, hypothyroidism, hyposodium, hypersodium, hypermagnesium, hyperkalemia; Others include severe infection, temperature instability, maternal anesthetics and magnesium sulfate, vagal reflex (gastric tube insertion, excessive neck flexion and extension).

研究实施时间：

Study execute time：

从 From 2023-04-01 00:00:00至 To 2024-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-04-01 00:00:00 至 To 2024-08-31 00:00:00  

干预措施：

Interventions：

组别：

实验组

样本量：

14

Group：

experimental group

Sample size：

干预措施：

俯卧位通气30°

干预措施代码：

Intervention：

Prone position ventilation 30℃

Intervention code：

组别：

实验组

样本量：

22

Group：

experimental group

Sample size：

干预措施：

俯卧位通气15°

干预措施代码：

Intervention：

Prone position ventilation 15℃

Intervention code：

组别：

实验组

样本量：

14

Group：

experimental group

Sample size：

干预措施：

俯卧位通气0°

干预措施代码：

Intervention：

Prone position ventilation 0℃

Intervention code：

组别：

观察组

样本量：

50

Group：

Supine ventilation 0℃

Sample size：

干预措施：

仰卧位通气0°

干预措施代码：

Intervention：

Supine ventilation 0℃

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 云南省 

市(区县)：

 曲靖市 

Country：

China 

Province：

Yunnan 

City：

Qujing 

单位(医院)：

曲靖市妇幼保健院寥廓院区 

单位级别：

三级甲等 

Institution
hospital：

Qujing Women's and Children's Health Care Hospital Area

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

呼吸暂停觉醒时间

指标类型：

主要指标

Outcome：

Apnea awakening time

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作次数

指标类型：

主要指标

Outcome：

The number of apnea episodes

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作时间

指标类型：

主要指标

Outcome：

Apnea onset time

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作时间

指标类型：

主要指标

Outcome：

Apnea onset time

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作时氧饱和度

指标类型：

主要指标

Outcome：

Oxygen saturation at apnea onset

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作时氧饱和度

指标类型：

主要指标

Outcome：

Oxygen saturation at apnea onset

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作时有无刺激恢复

指标类型：

主要指标

Outcome：

There is no stimulation to recover from apnea attack

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作时心率

指标类型：

主要指标

Outcome：

Heart rate during apnea seizure

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作时心率

指标类型：

主要指标

Outcome：

Heart rate during apnea seizure

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作时最低心率

指标类型：

主要指标

Outcome：

Minimum heart rate during apnea episodes

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作时最低心率

指标类型：

主要指标

Outcome：

Minimum heart rate during apnea episodes

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作时是否需要正压通气

指标类型：

主要指标

Outcome：

Whether positive pressure ventilation is required during apnea attacks

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停发作时是否需要正压通气

指标类型：

主要指标

Outcome：

Whether positive pressure ventilation is required during apnea attacks

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停时是否需要气管插管

指标类型：

主要指标

Outcome：

Whether a tracheal intubation is necessary during apnea episodes

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸暂停时是否需要气管插管

指标类型：

主要指标

Outcome：

Whether a tracheal intubation is necessary during apnea episodes

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

none

组织：

Sample Name：

none

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 新生儿 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

数字顺序号抽号随机分组，随机生成器

Randomization Procedure (please state who generates the random number sequence and by what method)：

Number sequence number randomly grouped ，Random producer

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

双盲法。 指试验中受试对象、研究者、参与药物疗效和安全性评价的医护工作者、监察员、数据管理人员及统计分析人员都不知道治疗分配程序，即不知道某一受试者接受哪种处理。有些研究者为了获得所预期的试验结果而任意选择或挑选病例，修改病例报告表，如果使用双盲则能避免这种弊端，从而将偏倚降到最低。 PS：更为深入的还有三盲，是指在双盲的基础上，对研究的资料收集者、分析者进一步设盲，以最大程度上控制信息偏倚

Blinding：

double blind method This means that subjects, researchers, health care workers, monitors, data managers, and statistical analysts involved in evaluating the efficacy and safety of a drug are not aware of the treatment assignment procedure, that is, they do not know which treatment a subject receives. Some researchers arbitrarily select or select cases and modify the case report form in order to obtain the expected test results. If double-blind is used, this disadvantage can be avoided and bias can be minimized. PS: More in-depth is triple blindness, which means that on the basis of double blindness, data gatherers and analysts of the research are further blinded to control information bias to the greatest extent

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

知网数据库

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Knownet database

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

每天临床医务工作人员对研究对象进行数据记录，每天一个数据分析及监察人员进行监督，每月项目负责人汇总并分析记录。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Clinical medical staff recorded the data of the research objects every day, a data analysis and monitoring staff supervised the data every day, and the project leader summarized and analyzed the records every month.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-03-21 16:18:24