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. 2023 Jul 18;7(7):CD013660.
doi: 10.1002/14651858.CD013660.pub2.

Continuous positive airway pressure (CPAP) for apnoea of prematurity

Jacqueline J Ho  1 , Irena Zakarija-Grkovic  2 , Jia Wen Lok  3 , Eunice Lim  3 , Prema Subramaniam  4 , Jen Jen Leong  5
Affiliations

Continuous positive airway pressure (CPAP) for apnoea of prematurity

Jacqueline J Ho et al. Cochrane Database Syst Rev. .

Abstract
in English, Persian

Background: Apnoea of prematurity (AoP) is defined as a pause in breathing for 20 seconds or longer, or for less than 20 seconds when accompanied by bradycardia and hypoxaemia, in a preterm infant. An association between the severity of apnoea and neurodevelopmental delay has been reported. Continuous positive airway pressure (CPAP) is a form of non-invasive ventilatory assistance that has been shown to be relatively safe and effective in preventing and treating respiratory distress among preterm infants. It is less clear whether CPAP treatment is safe and effective in the prevention and treatment of AoP.

Objectives: 1. To assess the effects of CPAP on AoP in preterm infants (this may be compared to supportive care or mechanical ventilation). 2. To assess the effects of different CPAP delivery systems on AoP in preterm infants.

Search methods: Searches were conducted in September 2022 in the following databases: Cochrane Library, MEDLINE, Embase, and CINAHL. We also searched clinical trial registries and the reference lists of studies selected for inclusion.

Selection criteria: We included all randomised and quasi-randomised controlled trials (RCTs) in which researchers determined that CPAP was necessary for AoP in preterm infants (born before 37 weeks). Cross-over studies were also included, provided sufficient data were available for analysis.

Data collection and analysis: We used the standard methods of Cochrane and Cochrane Neonatal, including independent assessment of risk of bias and extraction of data by at least two review authors. Discrepancies were resolved by involvement of a third author. We used the GRADE approach to assess the certainty of evidence for the following outcomes: 1) failed CPAP; 2) apnoea; 3) adverse effects of CPAP.

Main results: We included four single-centre trials conducted in Malaysia, Spain, Germany, and North America, involving 138 infants with a mean/median gestation of 26 to 28 weeks. Two studies were parallel-group RCTs and two were cross-over trials. None of the studies compared CPAP with supportive care. All trials compared one form of CPAP with another. Two compared a variable flow device with ventilator CPAP, one compared two different variable flow devices, and one compared a variable flow device with bubble CPAP. Interventions were administered for periods ranging between six and 48 hours, with pressures between 4 and 6 cm H2O. We assessed all trials as having a high risk of bias for blinding of participants and personnel, and two studies for blinding of outcome assessors. We found a high risk of a carry-over effect in two studies where the washout period was not adequately described, and a high risk of bias in a study that appeared to use an analysis method not generally accepted for cross-over studies. Comparison 1. CPAP and supportive care compared to supportive care alone We did not identify any study for inclusion in this comparison. Comparison 2. CPAP delivered by different types of devices 2a. Variable flow compared to ventilator CPAP Two studies were included in this comparison. We are very uncertain whether there is any difference in the incidence of failed CPAP, defined as the need for mechanical ventilation (risk ratio (RR) 0.16, 95% confidence interval (CI) 0.01 to 2.90; 1 study, 26 participants; very low-certainty). We are very uncertain whether there is any difference in the frequency of apnoea events (mean difference (MD) per four-hour interval -0.10, 95% CI -1.30 to 1.10; 1 study, 26 participants; very low-certainty). We are uncertain whether there is any difference in adverse events. Neurodevelopmental outcomes were not reported. 2b. Variable flow compared to bubble CPAP We included one study in this comparison, but it did not report our pre-specified outcomes. 2c. Infant Flow variable flow CPAP compared to Medijet variable flow CPAP We are very uncertain whether there is any difference in the incidence of failed CPAP (RR 2.62, 95% CI 0.91 to 7.53; 1 study, 80 participants; very low-certainty). The frequency of apnoea was not reported, and we do not know whether there is any difference in adverse events. Neurodevelopmental outcomes were not reported. Comparison 3. CPAP compared to mechanical ventilation We did not identify any studies for inclusion in this comparison.

Authors' conclusions: Due to the limited available evidence, we are very uncertain whether any CPAP device is more effective than other forms of supportive care, other CPAP devices, or mechanical ventilation for the prevention and treatment of AoP. The devices used in these studies included two types of variable flow CPAP device: bubble CPAP and ventilator CPAP. For each comparison, data were only available from a single study. There are theoretical reasons why these devices might have different effects on AoP, therefore further trials are indicated.

پیشینه: آپنه مرتبط با نارس بودن (apnoea of prematurity; AoP) به صورت وقفه در تنفس به مدت 20 ثانیه یا بیشتر، یا کمتر از 20 ثانیه در صورت همراه شدن با برادی‌کاردی و هیپوکسمی در نوزاد نارس تعریف می‌شود. ارتباط میان شدت آپنه و تاخیر در تکامل سیستم عصبی گزارش شده است. فشار مثبت مداوم راه هوایی (continuous positive airway pressure; CPAP) نوعی کمک ونتیلاتوری غیر تهاجمی است که نشان داده شده در پیشگیری و درمان دیسترس تنفسی در نوزادان نارس، نسبتا بی‌خطر و موثر است. مشخص نیست درمان CPAP در پیشگیری و درمان AoP بی‌خطر و موثر است یا خیر. اهداف: 1. ارزیابی تاثیرات CPAP بر AoP در نوزادان نارس (این روش ممکن است با مراقبت‌های حمایتی یا ونتیلاسیون مکانیکی مقایسه شود). 2. ارزیابی تاثیرات استفاده از سیستم‌های مختلف ارائه CPAP بر AoP در نوزادان نارس. روش‌های جست‌وجو: جست‌وجوها در سپتامبر 2022 در بانک‌های اطلاعاتی زیر صورت گرفتند: کتابخانه کاکرین؛ MEDLINE؛ Embase و CINAHL. هم‌چنین پایگاه‌های ثبت کارآزمایی بالینی و فهرست منابع مطالعات منتخب را برای گنجاندن در مرور جست‌وجو کردیم. معیارهای انتخاب: همه کارآزمایی‌های تصادفی‌سازی و شبه‌‐تصادفی‌سازی و کنترل شده‌ای (randomised controlled trials; RCTs) را وارد کردیم که در آنها پژوهشگران تشخیص دادند استفاده از CPAP برای AoP در نوزادان نارس (متولد شده پیش از 37 هفته) ضروری است. مطالعات متقاطع (cross‐over) نیز گنجانده شدند، مشروط بر اینکه داده‌های کافی را برای آنالیز در دسترس قرار دادند. گردآوری و تجزیه‌وتحلیل داده‌ها: از روش‌های استاندارد کاکرین و گروه نوزادان در کاکرین، شامل ارزیابی مستقل خطر سوگیری (bias) و استخراج داده‌ها توسط دو نویسنده مرور استفاده کردیم. اختلاف‌نظرات با مشارکت نویسنده سوم حل‌وفصل شدند. از رویکرد درجه‌بندی توصیه، ارزیابی، توسعه و ارزشیابی (Grading of Recommendations Assessment, Development and Evaluation; GRADE) جهت ارزیابی قطعیت شواهد برای پیامدهای زیر استفاده کردیم: 1) CPAP ناموفق؛ 2) آپنه؛ 3) عوارض جانبی CPAP. نتایج اصلی: چهار کارآزمایی تک مرکزی را که در مالزی، اسپانیا، آلمان و آمریکای شمالی انجام شدند، شامل 138 نوزاد با میانگین (mean)/ میانه (median) سن بارداری 26 تا 28 هفته وارد کردیم. دو مطالعه، RCTهای گروه موازی (parallel‐group) و دو مطالعه کارآزمایی‏‌های متقاطع (cross‐over) بودند. هیچ یک از مطالعات CPAP را با مراقبت‌های حمایتی مقایسه نکردند. همه کارآزمایی‌ها یک شکل را از CPAP با دیگری مقایسه کردند. دو مورد یک دستگاه جریان متغیر را با ونتیلاتور CPAP مقایسه کردند، یک مورد دو دستگاه مختلف جریان متغیر را مقایسه کرد، و یک مورد یک دستگاه جریان متغیر را با CPAP حباب‌دار (bubble CPAP) مقایسه کرد. مداخلات برای دوره‌های میان شش و 48 ساعت، با فشار میان 4 و 6 سانتی‌متر H 2 O اعمال شدند. همه کارآزمایی‌ها را دارای خطر بالای سوگیری (bias) برای کورسازی (blinding) شرکت‌کنندگان و پرسنل و دو مطالعه را برای کورسازی (blinding) ارزیابان پیامد ارزیابی کردیم. در دو مطالعه که دوره پاک‌شدگی (washout period) به اندازه کافی توصیف نشد، خطر بالای تاثیر انتقال (carry‐over effect) را یافتیم و در مطالعه‌ای که به نظر می‌رسید از روش تحلیلی استفاده ‌کردند که به‌طور کلی برای مطالعات متقاطع (cross‐over) پذیرفته نیست، خطر بالای سوگیری (bias) را مشاهده کردیم. مقایسه 1. CPAP و مراقبت‌های حمایتی در مقایسه با مراقبت‌های حمایتی به تنهایی هیچ مطالعه‌ای را برای گنجاندن در این مقایسه شناسایی نکردیم. مقایسه 2. CPAP ارائه شده با انواع دستگاه‌های مختلف 2a. جریان متغیر در مقایسه با CPAP ونتیلاتور دو مطالعه در این مقایسه گنجانده شدند. مشخص نیست تفاوتی در بروز CPAP ناموفق، که به عنوان نیاز به ونتیلاسیون مکانیکی تعریف شده، وجود دارد یا خیر (خطر نسبی (RR): 0.16؛ 95% فاصله اطمینان (CI): 0.01 تا 2.90؛ 1 مطالعه، 26 شرکت‌کننده، قطعیت بسیار پائین). در رابطه با اینکه تفاوتی در فراوانی وقایع آپنه وجود دارد یا خیر، بسیار نامطمئن هستیم (تفاوت میانگین (MD) در فاصله هر چهار ساعت: 0.10‐؛ 95% CI؛ 1.30‐ تا 1.10؛ 1 مطالعه، 26 شرکت‌کننده، قطعیت بسیار پائین). ما مطمئن نیستیم که در میزان بروز عوارض جانبی، تفاوتی وجود دارد یا خیر. پیامد‌های تکامل سیستم عصبی گزارش نشدند. 2b. جریان متغیر در مقایسه با CPAP حباب‌دار یک مطالعه را در این مقایسه گنجاندیم، اما پیامدهای از پیش مشخص شده را گزارش نکرد. 2c. CPAP جریان متغیر Infant Flow در مقایسه با CPAP جریان متغیر مدیجت (Medijet) در مورد اینکه تفاوتی در بروز CPAP ناموفق وجود دارد یا خیر، بسیار نامطمئن هستیم (RR: 2.62؛ 95% CI؛ 0.91 تا 7.53؛ 1 مطالعه، 80 شرکت‌کننده؛ قطعیت بسیار پائین). فراوانی آپنه گزارش نشد، و نمی‌دانیم که تفاوتی در میزان عوارض جانبی وجود دارد یا خیر. پیامد‌های تکامل سیستم عصبی گزارش نشدند. مقایسه 3. CPAP در مقایسه با ونتیلاسیون مکانیکی هیچ مطالعه‌ای را برای گنجاندن در این مقایسه شناسایی نکردیم. نتیجه‌گیری‌های نویسندگان: با توجه به شواهد محدود موجود، در رابطه با اینکه هر نوعی از دستگاه CPAP نسبت به دیگر اشکال مراقبت‌های حمایتی، دیگر دستگاه‌های CPAP یا ونتیلاسیون مکانیکی برای پیشگیری و درمان AoP موثرتر است یا خیر، بسیار نامطمئن هستیم. دستگاه‌های مورد استفاده در این مطالعات شامل دو نوع دستگاه CPAP جریان متغیر بودن: CPAP حباب‌دار و CPAP ونتیلاتور. برای هر مقایسه، داده‌های فقط یک مطالعه واحد در دسترس بودند. دلایل نظری وجود دارد که نشان می‌دهد چرا این دستگاه‌ها ممکن است تاثیرات متفاوتی بر AoP داشته باشند، بنابراین انجام کارآزمایی‌های بیشتری لازم است.

Trial registration: ClinicalTrials.gov NCT00187434.

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Conflict of interest statement

JJH is an editor with Cochrane Neonatal. However, she had no involvement in the editorial processing of this review. She was also involved as a thesis supervisor for one of the included studies (Chua 2005).

PS has no conflict of interest to declare.

IZG has no conflict of interest to declare.

JJL has no conflict of interest to declare.

EL has no conflict of interest to declare.

JWL has no conflict of interest to declare.

Figures

1
1
Study flow diagram
2
2
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3
1.1
1.1. Analysis
Comparison 1: Variable flow versus conventional ventilator CPAP, Outcome 1: Failed CPAP
1.2
1.2. Analysis
Comparison 1: Variable flow versus conventional ventilator CPAP, Outcome 2: Apnoea events
1.3
1.3. Analysis
Comparison 1: Variable flow versus conventional ventilator CPAP, Outcome 3: Bronchopulmonary dysplasia at 36 weeks
1.4
1.4. Analysis
Comparison 1: Variable flow versus conventional ventilator CPAP, Outcome 4: Mortality to discharge
1.5
1.5. Analysis
Comparison 1: Variable flow versus conventional ventilator CPAP, Outcome 5: Gastrointestinal complications
2.1
2.1. Analysis
Comparison 2: Infant Flow variable flow CPAP versus Medijet variable flow CPAP, Outcome 1: Failed CPAP
See this image and copyright information in PMC

Update of

References

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References to other published versions of this review

Ho 2020c
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