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Protocol summary
This study is a double-blind parallel clinical trial in which 112 infants are divided into control and intervention groups. To evaluate the effect of inhaled epinephrine on the success rate of extubation of intubated neonates over 3 days
This study is a double-blind parallel clinical trial in which60 infants are divided into control and intervention groups. To evaluate the effect of inhaled epinephrine on the success rate of extubation of intubated neonates over 3 days
This study is a double-blind parallel clinical trial in which 112which60 infants are divided into control and intervention groups. To evaluate the effect of inhaled epinephrine on the success rate of extubation of intubated neonates over 3 days
این مطالعه یک مطالعه از نوع کارآزمایی بالینی parallel دو سوکور میباشد که در آن 112نوزاد به دو گروه کنترل و مداخله تقسیم بندی میگردند. برای بررسی اثر اپی نفرین استنشاقی بر میزان موفقیت اکستوباسیون نوزادان اینتوبه شده بیشتر از 3 روز
این مطالعه یک مطالعه از نوع کارآزمایی بالینی parallel دو سوکور میباشد که در آن60 نوزاد به دو گروه کنترل و مداخله تقسیم بندی میگردند. برای بررسی اثر اپی نفرین استنشاقی بر میزان موفقیت اکستوباسیون نوزادان اینتوبه شده بیشتر از 3 روز
این مطالعه یک مطالعه از نوع کارآزمایی بالینی parallel دو سوکور میباشد که در آن 112نوزادآن60 نوزاد به دو گروه کنترل و مداخله تقسیم بندی میگردند. برای بررسی اثر اپی نفرین استنشاقی بر میزان موفقیت اکستوباسیون نوزادان اینتوبه شده بیشتر از 3 روز
This study was performed on 112 neonates with intubation for more than 3 days. Immediately after extubation, half a cc of epinephrine 1/10000 or distilled water is used every three hours, which is reduced to 72 times. Using a ver.1.1 Random number generator, a list of random numbers will be generated. It is a double-blind study.
This study was performed on 60 neonates with intubation for more than 3 days. Immediately after extubation, half a cc of epinephrine 1/10000 or distilled water is used every three hours, which is reduced to 72 times. Using a ver.1.1 Random number generator, a list of random numbers will be generated. It is a double-blind study.
This study was performed on 11260 neonates with intubation for more than 3 days. Immediately after extubation, half a cc of epinephrine 1/10000 or distilled water is used every three hours, which is reduced to 72 times. Using a ver.1.1 Random number generator, a list of random numbers will be generated. It is a double-blind study.
این مطالعه بر 112 نوزاد نارس با وزن زیر 1700 یا سن زیر 34 هفته با اینتوباسیون بیشتر از 3 روز انجام می شود. بالافاصله بعد از اکستوباسیون نیم سی سی به ازای هر کیلوگرم وزن بدن نوزاد بخور اپی نفرین 1/10000 یا اب مقطر در هر سه ساعت استفاده می شود که طی 72 ساعت دفعات کمتر می شود. با استفاده از برنامه تصادفی سازی کامپیوتری( ver.1.1 Random number generator) لیستی از اعداد تصادفی در بازه 1 تا ۱۱۲ به صورت تصادفی تولید خواهد شد و مطالعه دو سوکور می باشد.
این مطالعه بر 112 نوزاد نارس با وزن زیر 1700 یا سن زیر 34 هفته با اینتوباسیون بیشتر از 3 روز انجام می شود. بالافاصله بعد از اکستوباسیون نیم سی سی به ازای هر کیلوگرم وزن بدن نوزاد بخور اپی نفرین 1/10000 یا اب مقطر در هر سه ساعت استفاده می شود که طی 72 ساعت دفعات کمتر می شود. با استفاده از برنامه تصادفی سازی کامپیوتری( ver.1.1 Random number generator) لیستی از اعداد تصادفی در بازه 1 تا 60 به صورت تصادفی تولید خواهد شد و مطالعه دو سوکور می باشد.
این مطالعه بر 112 نوزاد نارس با وزن زیر 1700 یا سن زیر 34 هفته با اینتوباسیون بیشتر از 3 روز انجام می شود. بالافاصله بعد از اکستوباسیون نیم سی سی به ازای هر کیلوگرم وزن بدن نوزاد بخور اپی نفرین 1/10000 یا اب مقطر در هر سه ساعت استفاده می شود که طی 72 ساعت دفعات کمتر می شود. با استفاده از برنامه تصادفی سازی کامپیوتری( ver.1.1 Random number generator) لیستی از اعداد تصادفی در بازه 1 تا ۱۱۲60 به صورت تصادفی تولید خواهد شد و مطالعه دو سوکور می باشد.
General information
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2021-11-22, 1400/09/01
2021-11-22 00:00:00
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2023-09-21, 1402/06/30
2023-09-21 00:00:00
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2023-10-22, 1402/07/30
2023-10-22 00:00:00
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Due to the insufficient number of patients in the last 2 years, 60 patients were included in the study, 6 of whom died, and data analysis was performed on 54 infants.
Due to the insufficient number of patients in the last 2 years, 60 patients were included in the study, 6 of whom died, and data analysis was performed on 54 infants.
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با توجه به تعداد ناکافی بیماران طی 2 سال اخیر 60 بیمار وارد مطالعه شدند که 6 مورد فوت شدند و انالیز داده ها بر 54 نوزاد انجام شد.
با توجه به تعداد ناکافی بیماران طی 2 سال اخیر 60 بیمار وارد مطالعه شدند که 6 مورد فوت شدند و انالیز داده ها بر 54 نوزاد انجام شد.
Using a computer randomization program (ver.1.1 Random number generator) A list of random numbers in the range 1 to 112 will be generated randomly. Random numbers from 1 to 56 will be assigned to the drug and from 57 to 112 to the placebo. Because the order of distribution of these numbers is random, so the assignment of treatment to people who enter the study in order will be done randomly. Eventually, this list will be presented to the person responsible for performing these measures, and the two drugs epinephrine and distilled water are the same color and are drawn in the same syringe. Finally, the therapist uses the order of the medications.
Using a computer randomization program (ver.1.1 Random number generator) A list of random numbers in the range 1 to 60 will be generated randomly. Random numbers from 1 to 30 will be assigned to the drug and from 31 to 60 to the placebo. Because the order of distribution of these numbers is random, so the assignment of treatment to people who enter the study in order will be done randomly. Eventually, this list will be presented to the person responsible for performing these measures, and the two drugs epinephrine and distilled water are the same color and are drawn in the same syringe. Finally, the therapist uses the order of the medications.
Using a computer randomization program (ver.1.1 Random number generator) A list of random numbers in the range 1 to 11260 will be generated randomly. Random numbers from 1 to 5630 will be assigned to the drug and from 5731 to 11260 to the placebo. Because the order of distribution of these numbers is random, so the assignment of treatment to people who enter the study in order will be done randomly. Eventually, this list will be presented to the person responsible for performing these measures, and the two drugs epinephrine and distilled water are the same color and are drawn in the same syringe. Finally, the therapist uses the order of the medications.
استفاده از برنامه تصادفی سازی کامپیوتری( ver.1.1 Random number generator) لیستی از اعداد تصادفی در بازه 1 تا ۱۱۲ به صورت تصادفی تولید خواهد شد. تخصیص شماره های تصادفی از شماره 1 تا 56 به دارو و از 57 تا 112 به دارونما اختصاص خواهد یافت. به دلیل اینکه ترتیب توزیع این اعداد به صورت تصادفی است بنابراین اختصاص روش درمانی به افرادی که به ترتیب وارد مطالعه میشوند به صورت تصادفی انجام خواهد گرفت. در نهایت این لیست به فردی که مسیول انجام این اقدامات هست ارائه خواهد گردید و این دو دارو اپی نفرین و اب مقطر هم رنگ هستند و در سرنگ همشکل کشیده می شوند . در نهایت درمانگر با استفاده از ترتیب چیدمان داروها را استفاده می کند.
استفاده از برنامه تصادفی سازی کامپیوتری( ver.1.1 Random number generator) لیستی از اعداد تصادفی در بازه 1 تا 60 به صورت تصادفی تولید خواهد شد. تخصیص شماره های تصادفی از شماره 1 تا 30 به دارو و از31 تا 60 به دارونما اختصاص خواهد یافت. به دلیل اینکه ترتیب توزیع این اعداد به صورت تصادفی است بنابراین اختصاص روش درمانی به افرادی که به ترتیب وارد مطالعه میشوند به صورت تصادفی انجام خواهد گرفت. در نهایت این لیست به فردی که مسیول انجام این اقدامات هست ارائه خواهد گردید و این دو دارو اپی نفرین و اب مقطر هم رنگ هستند و در سرنگ همشکل کشیده می شوند . در نهایت درمانگر با استفاده از ترتیب چیدمان داروها را استفاده می کند.
استفاده از برنامه تصادفی سازی کامپیوتری( ver.1.1 Random number generator) لیستی از اعداد تصادفی در بازه 1 تا ۱۱۲60 به صورت تصادفی تولید خواهد شد. تخصیص شماره های تصادفی از شماره 1 تا 5630 به دارو و از 57از31 تا 11260 به دارونما اختصاص خواهد یافت. به دلیل اینکه ترتیب توزیع این اعداد به صورت تصادفی است بنابراین اختصاص روش درمانی به افرادی که به ترتیب وارد مطالعه میشوند به صورت تصادفی انجام خواهد گرفت. در نهایت این لیست به فردی که مسیول انجام این اقدامات هست ارائه خواهد گردید و این دو دارو اپی نفرین و اب مقطر هم رنگ هستند و در سرنگ همشکل کشیده می شوند . در نهایت درمانگر با استفاده از ترتیب چیدمان داروها را استفاده می کند.
Because it is a double-blind clinical trial, a randomized list is provided to the pharmacist to produce a sequence that fits the drug packages so that it is identical in appearance and so on. The packages will then be given to the therapist. Appointment treatment will be given to patients according to the order of tablets from 1 to 112, which includes 56 syringes containing epinephrine for incense and 56 syringes containing distilled water for incense, which was done by the pharmacist according to a random list. After the pharmacist prepares the drugs, he will deliver them to the researcher and the researcher will provide them to the therapist. In this case, the therapist does not know which patient is receiving which treatment after randomization.
Because it is a double-blind clinical trial, a randomized list is provided to the pharmacist to produce a sequence that fits the drug packages so that it is identical in appearance and so on. The packages will then be given to the therapist. Appointment treatment will be given to patients according to the order of tablets from 1 to 60, which includes 30 syringes containing epinephrine for incense and 30 syringes containing distilled water for incense, which was done by the pharmacist according to a random list. After the pharmacist prepares the drugs, he will deliver them to the researcher and the researcher will provide them to the therapist. In this case, the therapist does not know which patient is receiving which treatment after randomization.
Because it is a double-blind clinical trial, a randomized list is provided to the pharmacist to produce a sequence that fits the drug packages so that it is identical in appearance and so on. The packages will then be given to the therapist. Appointment treatment will be given to patients according to the order of tablets from 1 to 11260, which includes 5630 syringes containing epinephrine for incense and 5630 syringes containing distilled water for incense, which was done by the pharmacist according to a random list. After the pharmacist prepares the drugs, he will deliver them to the researcher and the researcher will provide them to the therapist. In this case, the therapist does not know which patient is receiving which treatment after randomization.
به دلیل اینکه کارآزمایی بالینی دو سوکور میباشد فهرست تصادفی تهیه شده به داروساز ارائه میگردد تا دنباله ای متناسب با بسته های داروئی میباشد تولید گردد به نحوی که در شکل ظاهری و غیره یکسان باشد. آنگاه بسته ها در اختیار درمانگر قرار خواهد گرفت. گمارش درمانی با توجه به ترتیب قرصها از 1 تا ۱۱۲ که شامل ۵۶ سرنگ حاوی اپی نفرین جهت بخور و ۵۶ سرنگ حاوی اب مقطر جهت بخور است به بیماران صورت خواهد پذیرفت که این ترتیب توسط داروساز با توجه به لیست تصادفی انجام گرفته است. پس از اینکه داروساز دارو ها را آماده سازی نمود به پژوهشگر تحویل خواهد داد و پژوهشگر در اختیار درمانگر قرار میدهد. در این حالت درمانگر پس از تصادفی سازی نمیداند که کدام بیمار تحت کدام درمان قرار گرفته است.
به دلیل اینکه کارآزمایی بالینی دو سوکور میباشد فهرست تصادفی تهیه شده به داروساز ارائه میگردد تا دنباله ای متناسب با بسته های داروئی میباشد تولید گردد به نحوی که در شکل ظاهری و غیره یکسان باشد. آنگاه بسته ها در اختیار درمانگر قرار خواهد گرفت. گمارش درمانی با توجه به ترتیب قرصها از 1 تا 60 که شامل 30 سرنگ حاوی اپی نفرین جهت بخور و 30 سرنگ حاوی اب مقطر جهت بخور است به بیماران صورت خواهد پذیرفت که این ترتیب توسط داروساز با توجه به لیست تصادفی انجام گرفته است. پس از اینکه داروساز دارو ها را آماده سازی نمود به پژوهشگر تحویل خواهد داد و پژوهشگر در اختیار درمانگر قرار میدهد. در این حالت درمانگر پس از تصادفی سازی نمیداند که کدام بیمار تحت کدام درمان قرار گرفته است.
به دلیل اینکه کارآزمایی بالینی دو سوکور میباشد فهرست تصادفی تهیه شده به داروساز ارائه میگردد تا دنباله ای متناسب با بسته های داروئی میباشد تولید گردد به نحوی که در شکل ظاهری و غیره یکسان باشد. آنگاه بسته ها در اختیار درمانگر قرار خواهد گرفت. گمارش درمانی با توجه به ترتیب قرصها از 1 تا ۱۱۲60 که شامل ۵۶30 سرنگ حاوی اپی نفرین جهت بخور و ۵۶30 سرنگ حاوی اب مقطر جهت بخور است به بیماران صورت خواهد پذیرفت که این ترتیب توسط داروساز با توجه به لیست تصادفی انجام گرفته است. پس از اینکه داروساز دارو ها را آماده سازی نمود به پژوهشگر تحویل خواهد داد و پژوهشگر در اختیار درمانگر قرار میدهد. در این حالت درمانگر پس از تصادفی سازی نمیداند که کدام بیمار تحت کدام درمان قرار گرفته است.
Recruitment centers
#1
Name of recruitment center - English: Shariati Hospital
Name of recruitment center - Persian: بیمارستان شریعتی
Full name of responsible person - English: Setareh Sagheb
Full name of responsible person - Persian: ستاره ثاقب
Street address - English: Tehran, North Kargar Street, Jalal Al-Ahmad Three Ways
Street address - Persian: تهران.خیابان کارگر شمالی.سه راه جلال ال احمد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713135
Phone: +98 21 8490 1000
Fax:
Email: shariatihosp@tums.ac.ir
Web page address:
Name of recruitment center - English: Shariati Hospital
Name of recruitment center - Persian: بیمارستان شریعتی
Full name of responsible person - English: Setareh Sagheb
Full name of responsible person - Persian: ستاره ثاقب
Street address - English: Jalal Al-Ahmad Three Ways, North Kargar Street, Tehran
Street address - Persian: تهران.خیابان کارگر شمالی.سه راه جلال ال احمد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713135
Phone: +98 21 8490 1000
Fax:
Email: shariatihosp@tums.ac.ir
Web page address:
Name of recruitment center - English: Shariati Hospital Name of recruitment center - Persian: بیمارستان شریعتی Full name of responsible person - English: Setareh Sagheb Full name of responsible person - Persian: ستاره ثاقب Street address - English: TehranJalal Al-Ahmad Three Ways, North Kargar Street, Jalal Al-Ahmad Three WaysTehran Street address - Persian: تهران.خیابان کارگر شمالی.سه راه جلال ال احمد City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713135 Phone: +98 21 8490 1000 Fax: Email: shariatihosp@tums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ameneh lamsehchi
Full name of responsible person - Persian: امنه لمسه چی
Street address - English: Keshavarz Blvd., Corner of Ghods St., Central Organization of Tehran University of Medical Sciences,
Street address - Persian: بلوار كشاورز، نبش خيابان قدس، سازمان مركزی دانشگاه علوم پزشكی تهران،
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 81633125
Phone: +98 21 8163 3102
Fax:
Email: itcenter@tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ameneh lamsehchi
Full name of responsible person - Persian: امنه لمسه چی
Street address - English: Central Organization of Tehran University of Medical Sciences, Corner of Ghods St.,Keshavarz Blvd.,
Street address - Persian: بلوار كشاورز، نبش خيابان قدس، سازمان مركزی دانشگاه علوم پزشكی تهران،
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 81633125
Phone: +98 21 8163 3102
Fax:
Email: itcenter@tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ameneh lamsehchi Full name of responsible person - Persian: امنه لمسه چی Street address - English: Keshavarz Blvd., Corner of Ghods St., Central Organization of Tehran University of Medical Sciences, Corner of Ghods St.,Keshavarz Blvd., Street address - Persian: بلوار كشاورز، نبش خيابان قدس، سازمان مركزی دانشگاه علوم پزشكی تهران، City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 81633125 Phone: +98 21 8163 3102 Fax: Email: itcenter@tums.ac.ir Web page address:
Protocol summary
Study aim
To Investigate the Efficacy of Inhaled Epinephrine in Extubation of Preterm Neonates in Neonatal Intensive Care
Design
This study is a double-blind parallel clinical trial in which60 infants are divided into control and intervention groups. To evaluate the effect of inhaled epinephrine on the success rate of extubation of intubated neonates over 3 days
Settings and conduct
This study was performed on 60 neonates with intubation for more than 3 days. Immediately after extubation, half a cc of epinephrine 1/10000 or distilled water is used every three hours, which is reduced to 72 times. Using a ver.1.1 Random number generator, a list of random numbers will be generated. It is a double-blind study.
Participants/Inclusion and exclusion criteria
The causes of premature infants and intubation are more than 3 days in the neonatal intensive care unit of Shariati Hospital in Tehran.
Exclusion criteria are infants with chronic lung disease and chronic heart or nerve disease, and infants with genetic and syndromic diseases, as well as term infants over 34 weeks and weighing less than 1700 grams.
Intervention groups
To evaluate the effect of inhaled epinephrine on the success rate of neonatal extubation, 112 intubated neonates over 3 days were randomly divided into two groups receiving inhaled epinephrine immediately after extubation or distilled water intake group. 0/5 cc L-Epinephrine 1/10000 were nebulized every three hours to 24 hours. Then reduce the frequency to 72 hours from the time it starts until it stops in 72 hours.
Main outcome variables
Vital signs (heart rate, blood pressure, and respiration rate), respiratory distress, and stridor after intubation, the number of re-intubations, the duration of intubation, and the length of time the infant was admitted to the ward are recorded in the records.
General information
Reason for update
Due to the insufficient number of patients in the last 2 years, 60 patients were included in the study, 6 of whom died, and data analysis was performed on 54 infants.
Acronym
IRCT registration information
IRCT registration number:IRCT20210607051507N4
Registration date:2021-11-17, 1400/08/26
Registration timing:prospective
Last update:2023-11-17, 1402/08/26
Update count:2
Registration date
2021-11-17, 1400/08/26
Registrant information
Name
Ameneh Lamsehchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 1315
Email address
lamsehchila@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
2021-11-22, 1400/09/01
Actual recruitment end date
2023-09-21, 1402/06/30
Trial completion date
2023-10-22, 1402/07/30
Scientific title
To Investigate the Efficacy of Inhaled Epinephrine in Extubation of Preterm Neonates in Neonatal Intensive Care
Public title
To Investigate the Efficacy of Inhaled Epinephrine in Extubation of Preterm Neonates in Neonatal Intensive Care
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants with intubation for more than 3 days in the neonatal intensive care unit of Shariati Hospital in Tehran
Exclusion criteria:
Chronic lung disease
Chronic heart disease
nerve disease
infants with a genetic and syndromic disease
term infants over 34 weeks and weighing less than 1700 grams.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
112
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using a computer randomization program (ver.1.1 Random number generator) A list of random numbers in the range 1 to 60 will be generated randomly. Random numbers from 1 to 30 will be assigned to the drug and from 31 to 60 to the placebo. Because the order of distribution of these numbers is random, so the assignment of treatment to people who enter the study in order will be done randomly. Eventually, this list will be presented to the person responsible for performing these measures, and the two drugs epinephrine and distilled water are the same color and are drawn in the same syringe. Finally, the therapist uses the order of the medications.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because it is a double-blind clinical trial, a randomized list is provided to the pharmacist to produce a sequence that fits the drug packages so that it is identical in appearance and so on. The packages will then be given to the therapist. Appointment treatment will be given to patients according to the order of tablets from 1 to 60, which includes 30 syringes containing epinephrine for incense and 30 syringes containing distilled water for incense, which was done by the pharmacist according to a random list. After the pharmacist prepares the drugs, he will deliver them to the researcher and the researcher will provide them to the therapist. In this case, the therapist does not know which patient is receiving which treatment after randomization.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Room 605, sixth floor, corner of Ghods st.,Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
42911450
Approval date
2021-09-23, 1400/07/01
Ethics committee reference number
IR.TUMS.CHMC.REC.1400.122
Health conditions studied
1
Description of health condition studied
To Investigate the Efficacy of Inhaled Epinephrine in Extubation of Preterm Neonates in Neonatal Intensive Care
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
Pco2 in ABG
Timepoint
Six hours after extubation in the target group and placebo
Method of measurement
ABG
2
Description
FIO2 percent
Timepoint
24 hours after the start of epinephrine or stilled water after extubation
Method of measurement
Record of ventilator
3
Description
High blood pressure
Timepoint
24 hours after extubation
Method of measurement
Pressure control machine
4
Description
Tachycardia (a heart rate above 180 beats per minute in the baby)
Timepoint
24 hours after extubation
Method of measurement
cardiac monitoring
5
Description
Tachypnea ( the number of breaths above 60 per minute in the baby)
Timepoint
24 hours after extubation
Method of measurement
Counted by the nurse and recorded in the file
6
Description
Surfactant requirement
Timepoint
During hospitalization
Method of measurement
Extraction from the patient file
7
Description
Death
Timepoint
During hospitalization
Method of measurement
Extraction of patient file
8
Description
Reintubation after extubation failure
Timepoint
During hospitalization
Method of measurement
Extract from the file
9
Description
Intubation time
Timepoint
Hospitalization duration
Method of measurement
Extract from file
10
Description
Duration of mechanical ventilation
Timepoint
Duration of mechanical ventilation
Method of measurement
Extract from file
11
Description
The age of the baby at the time of intubation
Timepoint
The age of the baby at the time of intubation
Method of measurement
Extract of file
12
Description
Gender of the baby
Timepoint
In hospitalization
Method of measurement
Extract from file
13
Description
Gestational age
Timepoint
Hospitalization
Method of measurement
Extract from file
Secondary outcomes
1
Description
Duration of non-invasive mechanical ventilation such as NIPPV.NCPAP after extubation
Timepoint
After extubation
Method of measurement
Extract from file
Intervention groups
1
Description
Intervention group: 0.5 cc per kg L-epinephrine 1/10000 were used as every three hours to 24 hours. Then reduce the frequency to 72 hours from the time of onset to interruption in 72 hours
Category
Treatment - Devices
2
Description
Control group: Half a cc per kilogram of infant weight was distilled every three hours to 24 hours. Then reduce the frequency to 72 hours from the time of onset to interruption in 72 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Setareh Sagheb
Street address
Jalal Al-Ahmad Three Ways, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ameneh lamsehchi
Street address
Central Organization of Tehran University of Medical Sciences, Corner of Ghods St.,Keshavarz Blvd.,
City
Tehran
Province
Tehran
Postal code
81633125
Phone
+98 21 8163 3102
Email
itcenter@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ameneh Lamsehchi
Position
Non-faculty specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Central Organization of Tehran University of Medical Sciences, corner of Ghods Street, Keshavarz Boulevard,
City
Tehran
Province
Tehran
Postal code
81633125
Phone
+98 21 8163 3102
Email
lamsehchila@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Setareh Sagheb
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shariati Hospital, Jalal Al-Ahmad Three Ways, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
00084901-021
Email
dr.ssagheb@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ameneh Lamsehchi
Position
Non-faculty specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Central Organization of Tehran University of Medical Sciences, corner of Ghods Street, Keshavarz Boulevard,
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3102
Email
Lamsehchila@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available