Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Determining the effect of maternal vitamin D intake during labor on the incidence of transient neonatal tachypnea
Determining the effect of maternal vitamin D intake during labor on the incidence of transient neonatal tachypnea
Determining the effect of maternal vitamin D intake during labor on the incidence of transient neonatal tachypnea
تعیین تاثیر دریافت ویتامین دی در مادرموقع زایمان بر بروز تاکی پنه گذرای نوزادی
تعیین تاثیر دریافت ویتامین دی در مادر موقع زایمان بر بروز تاکی پنه گذرای نوزادی
تعیین تاثیر دریافت ویتامین دی در مادرموقعمادر موقع زایمان بر بروز تاکی پنه گذرای نوزادی
Clinical trial with control group, parallel groups, single blind, randomized with a sample size of 80 people in any groups from March 2020 to November 2020
Clinical trial with control group, parallel groups, single blind, randomized with a sample size of 80 people in any groups
Clinical trial with control group, parallel groups, single blind, randomized with a sample size of 80 people in any groups from March 2020 to November 2020
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، تصادفی شده با حجم نمونه 80 نفر در هرگروه از اسفند 1398 تا آبان 99
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سویه کور، تصادفی شده با حجم نمونه 80 نفر
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سویه کور، تصادفی شده با حجم نمونه 80 نفر در هرگروه از اسفند 1398 تا آبان 99
در بخش مامایی و زایشگاه بیمارستان قائم مشهد،مادران دو گروه انتخاب میگردند و گروه مداخله ویتامین د دریافت می نمایند محقق بدون اطلاع از گروه مادران به بررسی نوزادان می پردازد وآنها را از نظر بروز یا عدم بروز تاکی پنه نوزادی بررسی می کند
از مادر و نوزاد در طی زایمان سطح ویتامین D اندازه گیری خواهد شد
در بخش مامایی و زایشگاه بیمارستان قائم مشهد، مادران دو گروه انتخاب میگردند و گروه مداخله ویتامین د دریافت می نمایند محقق بدون اطلاع از گروه مادران به بررسی نوزادان می پردازد و آنها را از نظر بروز یا عدم بروز تاکی پنه نوزادی بررسی می کند
از مادر و نوزاد در طی زایمان سطح ویتامین D اندازه گیری خواهد شد
در بخش مامایی و زایشگاه بیمارستان قائم مشهد،مادران دو گروه انتخاب میگردند و گروه مداخله ویتامین د دریافت می نمایند محقق بدون اطلاع از گروه مادران به بررسی نوزادان می پردازد وآنهاو آنها را از نظر بروز یا عدم بروز تاکی پنه نوزادی بررسی می کند از مادر و نوزاد در طی زایمان سطح ویتامین D اندازه گیری خواهد شد
Inclusion criteria: Mothers with gestational age greater than 32 weeks who have delivery symptoms will be enrolled in the study.
Exclusion criteria:Mothers with asthma
Inclusion criteria: Mothers with gestational age greater than 32 weeks who have delivery symptoms will be enrolled in the study.
Exclusion criteria: Mothers with asthma
Inclusion criteria: Mothers with gestational age greater than 32 weeks who have delivery symptoms will be enrolled in the study. Exclusion criteria:Mothers with asthma
شرایط ورود:مادران با سن حاملگی بیشتر از 32 هفته که علایم زایمانی دارند وارد مطالعه خواهند شد .
شرایط عدم ورود: مادران مبتلا به آسم
شرایط ورود: مادران با سن حاملگی بیشتر از 32 هفته که علایم زایمانی دارند وارد مطالعه خواهند شد.
شرایط عدم ورود: مادران مبتلا به آسم
شرایط ورود:مادران با سن حاملگی بیشتر از 32 هفته که علایم زایمانی دارند وارد مطالعه خواهند شد. شرایط عدم ورود: مادران مبتلا به آسم
گروه مداخله :قبل از زایمان یک نوبت ،یک ششم آمپول ویتامین د( 50000 واحد )ساخت کارخانه کاسپین تزریق می شود
گروه کنترل :ویتامین د دریافت نمیکنند
گروه مداخله: قبل از زایمان یک نوبت، یک ششم آمپول ویتامین د ( 50000 واحد) ساخت کارخانه کاسپین تزریق می شود
گروه کنترل: ویتامین د دریافت نمیکنند
گروه مداخله:قبل از زایمان یک نوبت،یک ششم آمپول ویتامین د( 50000 واحد)ساخت کارخانه کاسپین تزریق می شود گروه کنترل:ویتامین د دریافت نمیکنند
transient tachypnea of newborn
Transient tachypnea of newborn
transientTransient tachypnea of newborn
General information
2020-02-20, 1398/12/01
2021-01-19, 1399/10/30
20202021-0201-2019 00:00:00
2020-10-30, 1399/08/09
2024-08-29, 1403/06/08
20202024-1008-3029 00:00:00
empty
Dear IRCT Director
Please correct the start and end dates of the project as follows if possible
Thank you
IRCT registration number: IRCT20110807007244N5 Registration date: 2020-07-01, 1399/04/11 Registration timing: retrospective Last update: 2020-07-01, 1399/04/11
Registration date 2020-07-01, 1399/04/11
Expected recruitment start date 2021-01-19, 1399/10/30
Expected recruitment end date 2024-08-29, 1405/04/06
Approval date Ethic: 2020-06-24, 1399/04/04
Dear IRCT Director Please correct the start and end dates of the project as follows if possible Thank you IRCT registration number: IRCT20110807007244N5 Registration date: 2020-07-01, 1399/04/11 Registration timing: retrospective Last update: 2020-07-01, 1399/04/11 Registration date 2020-07-01, 1399/04/11 Expected recruitment start date 2021-01-19, 1399/10/30 Expected recruitment end date 2024-08-29, 1405/04/06 Approval date Ethic: 2020-06-24, 1399/04/04
empty
مدیر محترم IRCT
خواهشمند است در صورت امکان تاریخ شروع و خاتمه طرح بشرح زیر اصلاح گردد
با تشکر
IRCT registration number: IRCT20110807007244N5 Registration date: 2020-07-01, 1399/04/11 Registration timing: retrospective Last update: 2020-07-01, 1399/04/11
Registration date 2020-07-01, 1399/04/11
Expected recruitment start date 2021-01-19, 1399/10/30
Expected recruitment end date 2024-08-29, 1405/04/06
Approval date Ethic: 2020-06-24, 1399/04/04
مدیر محترم IRCT خواهشمند است در صورت امکان تاریخ شروع و خاتمه طرح بشرح زیر اصلاح گردد با تشکر IRCT registration number: IRCT20110807007244N5 Registration date: 2020-07-01, 1399/04/11 Registration timing: retrospective Last update: 2020-07-01, 1399/04/11 Registration date 2020-07-01, 1399/04/11 Expected recruitment start date 2021-01-19, 1399/10/30 Expected recruitment end date 2024-08-29, 1405/04/06 Approval date Ethic: 2020-06-24, 1399/04/04
The effect of vitamin D administration during labor on the incidence of Transient rapid breathing of the Newborn
The effect of vitamin d administration during labor on the incidence of Transient rapid breathing of the Newborn
The effect of vitamin Dd administration during labor on the incidence of Transient rapid breathing of the Newborn
The effect of vitamin D administration during labor on the incidence of Transient Tachypnea of the Newborn
The effect of vitamin d administration during labor on the incidence of Transient Tachypnea of the Newborn
The effect of vitamin Dd administration during labor on the incidence of Transient Tachypnea of the Newborn
Mothers with asthma
post term pregnancy
Mothers with asthma
Post term pregnancy
Mothers with asthma postPost term pregnancy
Health conditions studied
#1
Transient tachypnea of newborn
Transient Tachypnea of Newborn
Transient tachypneaTachypnea of newbornNewborn
Transient tachypnea of newborn
Transient Tachypnea of Newborn
Transient tachypneaTachypnea of newbornNewborn
Primary outcomes
#1
Frequency of transient tachypnea of newborn
Frequency of Transient Tachypnea of Newborn
Frequency of transient tachypneaTransient Tachypnea of newbornNewborn
Clinical and radiological signs and clinical course of transient tachypnea of newborn
Clinical and radiological signs and clinical course of Transient Tachypnea of Newborn
Clinical and radiological signs and clinical course of transient tachypneaTransient Tachypnea of newbornNewborn
Intervention groups
#1
گروه مداخله: مادران حامله با علایم زایمانی با سن حاملگی بیشتر از 32 هفته در چهار ساعت تا سه روز قبل از زایمان، 50000 واحد(یک ششم آمپول) ویتامین د تزریقی ، ساخت کارخانه کاسپین دریافت می کنند.
گروه مداخله: مادران حامله با علایم زایمانی با سن حاملگی بیشتر از 32 هفته در چهار ساعت تا سه روز قبل از زایمان، 50000 واحد (یک ششم آمپول) ویتامین د تزریقی، ساخت کارخانه کاسپین دریافت می کنند.
گروه مداخله: مادران حامله با علایم زایمانی با سن حاملگی بیشتر از 32 هفته در چهار ساعت تا سه روز قبل از زایمان، 50000 واحد(یکواحد (یک ششم آمپول) ویتامین د تزریقی، ساخت کارخانه کاسپین دریافت می کنند.
#2
گروه کنترل :مادران حامله با علایم زایمانی با سن حاملگی بیشتر از 32 هفته مداخله ای دریافت نمی کنند
گروه کنترل : مادران حامله با علایم زایمانی با سن حاملگی بیشتر از 32 هفته مداخله ای دریافت نمی کنند
گروه کنترل :مادران حامله با علایم زایمانی با سن حاملگی بیشتر از 32 هفته مداخله ای دریافت نمی کنند
Recruitment centers
#1
Name of recruitment center - English: Ghaem Hospital
Name of recruitment center - Persian: بیمارستان قائم
Full name of responsible person - English: Hassan Boskabadi
Full name of responsible person - Persian: حسن بسکابادی
Street address - English: Ahmadabad St.
Street address - Persian: خ احمد اباد
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: +98 51 3841 2069
Fax:
Email: Boskabadih@mums.ac.ir
Web page address:
Name of recruitment center - English: Ghaem Hospital
Name of recruitment center - Persian: بیمارستان قائم
Full name of responsible person - English: Hassan Boskabadi
Full name of responsible person - Persian: حسن بسکابادی
Street address - English: NICU, Ghaem Hospital,Ahmadabad St.
Street address - Persian: خ احمد اباد-بیمارستان قائم، بخش مراقبتهای ویزه نوزادان
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: +98 51 3841 2069
Fax:
Email: Boskabadih@mums.ac.ir
Web page address:
Name of recruitment center - English: Ghaem Hospital Name of recruitment center - Persian: بیمارستان قائم Full name of responsible person - English: Hassan Boskabadi Full name of responsible person - Persian: حسن بسکابادی Street address - English: AhmadabadNICU, Ghaem Hospital,Ahmadabad St. Street address - Persian: خ احمد اباد-بیمارستان قائم، بخش مراقبتهای ویزه نوزادان City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 91766-99199 Phone: +98 51 3841 2069 Fax: Email: Boskabadih@mums.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: Mohsen Tafaghodi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Daneshgah St.
Street address - Persian: خ دانشگاه
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: +98 51 3841 2081
Fax:
Email: Tafaghodim@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohsen Tafaghodi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Vice Chancellor for Research and Technology, Qureshi Building, University St.
Street address - Persian: خ دانشگاه-ساختمان قریشی،معاونت پزوهشی و فن آوری
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: +98 51 3841 2081
Fax:
Email: Tafaghodim@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohsen Tafaghodi Full name of responsible person - Persian: محسن تفقدی Street address - English: DaneshgahVice Chancellor for Research and Technology, Qureshi Building, University St. Street address - Persian: خ دانشگاه-ساختمان قریشی،معاونت پزوهشی و فن آوری City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 91766-99199 Phone: +98 51 3841 2081 Fax: Email: Tafaghodim@mums.ac.ir Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hassan Boskabadi
Full name of responsible person - Persian: حسن بسکابادی
Position - English: professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: NICU, Pediatrics Dep, Ghaem Hospital, Ahmadabad St.
Street address - Persian: خیابان احمد آباد ، بیمارستان قائم(عج)، بخش نوزادان
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: 00988412069
Mobile: +98 915 515 3987
Fax:
Email: Boskabadih@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hassan Boskabadi
Full name of responsible person - Persian: حسن بسکابادی
Position - English: Professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: NICU, Pediatrics Dep, Ghaem Hospital, Ahmadabad St.
Street address - Persian: خیابان احمد آباد، بیمارستان قائم(عج)، بخش نوزادان
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9176699199
Phone: 00988412069
Mobile: +98 915 515 3987
Fax:
Email: Boskabadih@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hassan Boskabadi Full name of responsible person - Persian: حسن بسکابادی Position - English: professorProfessor Position - Persian: استاد Latest degree: sub_specialist Area of specialty/work: 74 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: NICU, Pediatrics Dep, Ghaem Hospital, Ahmadabad St. Street address - Persian: خیابان احمد آباد، بیمارستان قائم(عج)، بخش نوزادان City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 91766-991999176699199 Phone: 00988412069 Mobile: +98 915 515 3987 Fax: Email: Boskabadih@mums.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hassan Boskabadi
Full name of responsible person - Persian: حسن بسکابادی
Position - English: Professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: NICU, Pediatrics Dep,Ghaem Hospital, Ahmadabad St.
Street address - Persian: خیابان احمد آباد ، بیمارستان قائم(عج)، بخش نوزادان
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: +98 51 3841 2069
Mobile: +98 915 515 3987
Fax:
Email: Boskabadih@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hassan Boskabadi
Full name of responsible person - Persian: حسن بسکابادی
Position - English: Professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: NICU, Pediatrics Dep, Ghaem Hospital, Ahmadabad St.
Street address - Persian: خیابان احمد آباد، بیمارستان قائم(عج)، بخش نوزادان
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9176699199
Phone: +98 51 3841 2069
Mobile: +98 915 515 3987
Fax:
Email: Boskabadih@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hassan Boskabadi Full name of responsible person - Persian: حسن بسکابادی Position - English: Professor Position - Persian: استاد Latest degree: sub_specialist Area of specialty/work: 74 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: NICU, Pediatrics Dep,GhaemDep, Ghaem Hospital, Ahmadabad St. Street address - Persian: خیابان احمد آباد، بیمارستان قائم(عج)، بخش نوزادان City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 91766-991999176699199 Phone: +98 51 3841 2069 Mobile: +98 915 515 3987 Fax: Email: Boskabadih@mums.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hassan Boskabadi
Full name of responsible person - Persian: حسن بسکابادی
Position - English: Professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: NICU, Pediatrics Dep, Ghaem Hospital, ahmadabad St.
Street address - Persian: خیابان احمد آباد ، بیمارستان قائم(عج) ، بخش نوزادان
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: +98 51 3841 2069
Mobile: +98 915 515 3987
Fax:
Email: Boskabadih@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hassan Boskabadi
Full name of responsible person - Persian: حسن بسکابادی
Position - English: Professor
Position - Persian: استاد
Latest degree: sub_specialist
Area of specialty/work: 74
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: NICU, Pediatrics Dep, Ghaem Hospital, Ahmadabad St.
Street address - Persian: خیابان احمد آباد، بیمارستان قائم(عج)، بخش نوزادان
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9176699199
Phone: +98 51 3841 2069
Mobile: +98 915 515 3987
Fax:
Email: Boskabadih@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hassan Boskabadi Full name of responsible person - Persian: حسن بسکابادی Position - English: Professor Position - Persian: استاد Latest degree: sub_specialist Area of specialty/work: 74 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: NICU, Pediatrics Dep, Ghaem Hospital, ahmadabadAhmadabad St. Street address - Persian: خیابان احمد آباد، بیمارستان قائم(عج)، بخش نوزادان City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 91766-991999176699199 Phone: +98 51 3841 2069 Mobile: +98 915 515 3987 Fax: Email: Boskabadih@mums.ac.ir Web page address:
Protocol summary
Study aim
Determining the effect of maternal vitamin D intake during labor on the incidence of transient neonatal tachypnea
Design
Clinical trial with control group, parallel groups, single blind, randomized with a sample size of 80 people in any groups
Settings and conduct
In the midwifery and maternity ward of the Ghaem hospital of Mashhad, the mothers of the two groups are selected and the intervention group receives vitamin D. The researcher examines the infants without knowing the mothers group and examines them for the presence or absence of Transient Tachypnea of the Newborn.
Vitamin D levels will be measured from mother and baby during delivery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers with gestational age greater than 32 weeks who have delivery symptoms will be enrolled in the study.
Exclusion criteria: Mothers with asthma
Intervention groups
Intervention group: Before delivery, one sixth vial of vitamin D (50,000 units) made by Caspian factory is injected.
Control group: They do not receive vitamin D.
Main outcome variables
Transient tachypnea of newborn
General information
Reason for update
Dear IRCT Director
Please correct the start and end dates of the project as follows if possible
Thank you
IRCT registration number: IRCT20110807007244N5 Registration date: 2020-07-01, 1399/04/11 Registration timing: retrospective Last update: 2020-07-01, 1399/04/11
Registration date 2020-07-01, 1399/04/11
Expected recruitment start date 2021-01-19, 1399/10/30
Expected recruitment end date 2024-08-29, 1405/04/06
Approval date Ethic: 2020-06-24, 1399/04/04
Acronym
IRCT registration information
IRCT registration number:IRCT20110807007244N5
Registration date:2020-12-01, 1399/09/11
Registration timing:prospective
Last update:2026-07-11, 1405/04/20
Update count:1
Registration date
2020-12-01, 1399/09/11
Registrant information
Name
Hassan Boskabadi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 515 3987
Email address
boskabadih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2024-08-29, 1403/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin d administration during labor on the incidence of Transient Tachypnea of the Newborn
Public title
The effect of vitamin d administration during labor on the incidence of Transient rapid breathing of the Newborn
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers upper 32 weeks with delivery symptoms
Exclusion criteria:
Mothers with asthma
Post term pregnancy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization will be used as a reliable randomization method that leads to a balanced allocation of individuals in treatment groups at the end of each block. For this purpose, using Random Allocation Software, a block randomization list with different sizes 4 or 6 is prepared, then according to the order of the contents of the blocks, which includes the group’s name and unique identification code, each patient is assigned to one of the groups
Blinding (investigator's opinion)
Single blinded
Blinding description
By referring the mother, the midwife accidentally opens one of the blocks and, without knowing the grouping, presents one of the numbers to a researcher who is aware of the type of group. The researcher injects 50000 IU from ampoule of vitamin D into the mother of the intervention group. The infant will be followed up by the principal investigator who is unaware of the type of group, of the presence or absence of transient tachypnea of newborn. Data entry in SPSS is done as groups A and B, and the data analyst is unaware from the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ethics committee,ّ3rd Floor, ghorashi bulding,Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-06-24, 1399/04/04
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.329
Health conditions studied
1
Description of health condition studied
Transient Tachypnea of Newborn
ICD-10 code
P22.1
ICD-10 code description
Transient Tachypnea of Newborn
Primary outcomes
1
Description
Frequency of Transient Tachypnea of Newborn
Timepoint
1-3 days after neonatal birth
Method of measurement
Clinical and radiological signs and clinical course of Transient Tachypnea of Newborn
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant mothers with symptoms of labor with a gestational age of more than 32 weeks in four hours to three days before delivery, receive 50,000 units (one sixth of an ampoule) of injectable vitamin D, made by Caspian factory.
Category
Prevention
2
Description
Control group: Pregnant mothers with labor symptoms with gestational age more than 32 weeks do not receive intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Hassan Boskabadi
Street address
NICU, Ghaem Hospital,Ahmadabad St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 2069
Email
Boskabadih@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research and Technology, Qureshi Building, University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3841 2081
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Boskabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NICU, Pediatrics Dep, Ghaem Hospital, Ahmadabad St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
00988412069
Email
Boskabadih@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Boskabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NICU, Pediatrics Dep, Ghaem Hospital, Ahmadabad St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 2069
Email
Boskabadih@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Boskabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NICU, Pediatrics Dep, Ghaem Hospital, Ahmadabad St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 2069
Email
Boskabadih@mums.ac.ir
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
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available