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
A randomized controlled clinical trial with a parallel group design of 100 mother, enrolled between January 2019 and September 2019
A randomized controlled clinical trial with a parallel group design of 100 mother, enrolled between Tuesday, February 4, 2020 and Sunday, September 20, 2020
A randomized controlled clinical trial with a parallel group design of 100 mother, enrolled between January 2019Tuesday, February 4, 2020 and Sunday, September 201920, 2020
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، تصادفی شده با حجم نمونه 100 نفر در مجموع دو گروه از بهمن 1397 تا شهریور 1398
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، تصادفی شده با حجم نمونه 175 نفر در مجموع دو گروه از تاریخ 15 بهمن 98 تا 30 شهریور 99
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، تصادفی شده با حجم نمونه 100175 نفر در مجموع دو گروه از تاریخ 15 بهمن 139798 تا 30 شهریور 139899
The study will be a clinical trial under the supervision of Mashhad University of Medical Sciences in 1397-1398. Preterm infants with gestational age of less than 34 weeks gestation of mothers who received vitamin D (the intervention group who received 50,000 units of vitamin D injections 72 hours before childbirth) with infants of mothers who did not received vitamin D would be compared in terms of incidence of RDS.
The study will be a clinical trial under the supervision of Mashhad University of Medical Sciences in 1398-1399. Preterm infants with gestational age of less than 34 weeks gestation of mothers who received vitamin D (the intervention group who received 50,000 units of vitamin D injections 72 hours before childbirth) with infants of mothers who did not received vitamin D would be compared in terms of incidence of RDS.
The study will be a clinical trial under the supervision of Mashhad University of Medical Sciences in 13971398-13981399. Preterm infants with gestational age of less than 34 weeks gestation of mothers who received vitamin D (the intervention group who received 50,000 units of vitamin D injections 72 hours before childbirth) with infants of mothers who did not received vitamin D would be compared in terms of incidence of RDS.
اين طرح به صورت يک کار آزمایی بالینی تحت نظارت دانشگاه علوم پزشکي مشهد در سال 98-1397 انجام خواهد شد. نوزادان نارس با دوره حاملگی کمتر از 34 هفته از مادران دریافت کننده ویتامین د (گروه مداخله که طی 72 ساعت قبل از تولد 50000 واحد ویتامین د تزریقی دریافت کرده اند ) با نوزادان مادران عدم دریافت کننده ویتامین د از نظر ابتلا به سندرم دیسترس تنفسی مورد مقایسه قرار میگیرند.
اين طرح به صورت يک کار آزمایی بالینی تحت نظارت دانشگاه علوم پزشکي مشهد در سال 99-1398 انجام خواهد شد. نوزادان نارس با دوره حاملگی کمتر از 34 هفته از مادران دریافت کننده ویتامین د (گروه مداخله که طی 72 ساعت قبل از تولد 50000 واحد ویتامین د تزریقی دریافت کرده اند ) با نوزادان مادران عدم دریافت کننده ویتامین د از نظر ابتلا به سندرم دیسترس تنفسی مورد مقایسه قرار میگیرند.
اين طرح به صورت يک کار آزمایی بالینی تحت نظارت دانشگاه علوم پزشکي مشهد در سال 9899-13971398 انجام خواهد شد. نوزادان نارس با دوره حاملگی کمتر از 34 هفته از مادران دریافت کننده ویتامین د (گروه مداخله که طی 72 ساعت قبل از تولد 50000 واحد ویتامین د تزریقی دریافت کرده اند ) با نوزادان مادران عدم دریافت کننده ویتامین د از نظر ابتلا به سندرم دیسترس تنفسی مورد مقایسه قرار میگیرند.
Pregnant woman with gestational age less than 37 weeks will be included the study and those mothers with drug abuse will be excluded .
Inclusion criteria ; All singleton pregnant women with a gestational age of less than 34 weeks, at risk of preterm delivery
Exclusion criteria;
• Cardiovascular diseases (except for preeclampsia /eclampsia)
• Asthma
• History of certain illicit and prescription drugs(including narcotics, antiepileptic, non-steroid anti-inflammatory drugs, sedative-hypnotics, and tocolytics)
• Multiple gestations
Pregnant womanInclusion criteria ; All singleton pregnant women with a gestational age of less than 3734 weeks will be included the study, at risk of preterm delivery Exclusion criteria; • Cardiovascular diseases (except for preeclampsia /eclampsia) • Asthma • History of certain illicit and those mothers with drug abuse will be excluded .prescription drugs(including narcotics, antiepileptic, non-steroid anti-inflammatory drugs, sedative-hypnotics, and tocolytics) • Multiple gestations
زنان باردار با سن حاملگی کمتر از 37 هفته وارد مطالعه شده و مادران دارای سوء مصرف مواد از مطالعه خارج ميشوند.
معیارهای ورود: تمام زنان حامله تک قل با سن حاملگی کمتر از 34 هفته که در ریسک زایمان زودرس هستد.
معیارهای خروج: بیماری های قلبی عروقی، آسم، سابقه مصرف مواد(نارکوتیک ها،ضد تشنج ،ضدالتهاب غیراستروئیدی،سداتیوهیپنوتیک ،توکولیتیک)
معیارهای ورود: تمام زنان باردارحامله تک قل با سن حاملگی کمتر از 3734 هفته وارد مطالعه شده و مادران دارای سوءکه در ریسک زایمان زودرس هستد. معیارهای خروج: بیماری های قلبی عروقی، آسم، سابقه مصرف مواد از مطالعه خارج ميشوند.مواد(نارکوتیک ها،ضد تشنج ،ضدالتهاب غیراستروئیدی،سداتیوهیپنوتیک ،توکولیتیک)
دیسترس تنفسی نوزادی بدنبال تزریق ویتامین D به مادر
کاهش سندروم دیسترس تنفسی نوزادی بدنبال تزریق ویتامین D به مادر
کاهش سندروم دیسترس تنفسی نوزادی بدنبال تزریق ویتامین D به مادر
General information
empty
238
238
empty
Day
day
Yes
No
1
Female
Both
femalboth
N/A
empty
na0
empty
175
175
empty
2020-02-04, 1398/11/15
2020-02-04 00:00:00
empty
2020-09-20, 1399/06/30
2020-09-20 00:00:00
empty
2020-09-20, 1399/06/30
2020-09-20 00:00:00
empty
Modification and updating of study data
Modification and updating of study data
empty
اصلاح و بروز رسانی داده های مطالعه
اصلاح و بروز رسانی داده های مطالعه
Pregnant woman with gestational age less than 37 weeks
All singleton pregnant women with a gestational age of less than 34 weeks, at risk of preterm delivery
Pregnant womanAll singleton pregnant women with a gestational age of less than 3734 weeks, at risk of preterm delivery
زنان باردارباسن حاملگی کمتراز37هفته
تمام زنان تک قل با سن حاملگی 34 هفته و کمتر با ریسک زایمان زودرس
تمام زنان باردارباسنتک قل با سن حاملگی کمتراز37هفته34 هفته و کمتر با ریسک زایمان زودرس
mothers with drug abuse
Cardiovascular diseases (except for preeclampsia /eclampsia)
Asthma
History of certain illicit and prescription drugs(including narcotics, antiepileptic, non-steroid anti-inflammatory drugs, sedative-hypnotics, and tocolytics)
Multiple gestations
mothers with drug abuseCardiovascular diseases (except for preeclampsia /eclampsia) Asthma History of certain illicit and prescription drugs(including narcotics, antiepileptic, non-steroid anti-inflammatory drugs, sedative-hypnotics, and tocolytics) Multiple gestations
مادران دارای سوء مصرف مواد
بیماری های قلبی عروقی
آسم
سابقه مصرف داروهای غیرمجاز(نارکوتیک ،ضد تشنج،ضد التهاب غیراستروئیدی،سداتیو هیپنوتیک ،توکولیتیک)
حاملگی چند قلویی
مادران دارای سوءبیماری های قلبی عروقی آسم سابقه مصرف موادداروهای غیرمجاز(نارکوتیک ،ضد تشنج،ضد التهاب غیراستروئیدی،سداتیو هیپنوتیک ،توکولیتیک) حاملگی چند قلویی
Health conditions studied
#1
دیسترس تنفسی
دیسترس تنفسی نوزادان
دیسترس تنفسی نوزادان
Protocol summary
Study aim
The purpose is to compare the incidence of respiratory distress in first 72 postpartum in preterm infants of mothers receiving vitamin D with those who won't receive.
Design
A randomized controlled clinical trial with a parallel group design of 100 mother, enrolled between Tuesday, February 4, 2020 and Sunday, September 20, 2020
Settings and conduct
The study will be a clinical trial under the supervision of Mashhad University of Medical Sciences in 1398-1399. Preterm infants with gestational age of less than 34 weeks gestation of mothers who received vitamin D (the intervention group who received 50,000 units of vitamin D injections 72 hours before childbirth) with infants of mothers who did not received vitamin D would be compared in terms of incidence of RDS.
Participants/Inclusion and exclusion criteria
Inclusion criteria ; All singleton pregnant women with a gestational age of less than 34 weeks, at risk of preterm delivery
Exclusion criteria;
• Cardiovascular diseases (except for preeclampsia /eclampsia)
• Asthma
• History of certain illicit and prescription drugs(including narcotics, antiepileptic, non-steroid anti-inflammatory drugs, sedative-hypnotics, and tocolytics)
• Multiple gestations
Intervention groups
The intervention group will receive 50,000 units of vitamin D injections 72 hours before childbirth and the control group won't receive any medication.
Main outcome variables
Neonatal respiratory distress reduction after prenatal maternal vitamin D injection
General information
Reason for update
Modification and updating of study data
Acronym
IRCT registration information
IRCT registration number:IRCT20190814044529N1
Registration date:2020-01-21, 1398/11/01
Registration timing:prospective
Last update:2022-04-25, 1401/02/05
Update count:1
Registration date
2020-01-21, 1398/11/01
Registrant information
Name
Mohammad Hosein Ataee Nakhaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3606 0413
Email address
ataeinmh971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-15, 1397/10/25
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
2020-02-04, 1398/11/15
Actual recruitment end date
2020-09-20, 1399/06/30
Trial completion date
2020-09-20, 1399/06/30
Scientific title
Comparison of the incidence of respiratory distress syndrome in neonates of mothers receiving vitamin D with those who do not receive
Public title
Effect of Vitamin D on neonatal respiratory distress
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All singleton pregnant women with a gestational age of less than 34 weeks, at risk of preterm delivery
Exclusion criteria:
Cardiovascular diseases (except for preeclampsia /eclampsia)
Asthma
History of certain illicit and prescription drugs(including narcotics, antiepileptic, non-steroid anti-inflammatory drugs, sedative-hypnotics, and tocolytics)
Multiple gestations
Age
To 238 days old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
175
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done based on simple random method using table of random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Vice chancellor for research, Mashhad University of Medical Sciences, aneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2016-08-17, 1395/05/27
Ethics committee reference number
IR.MUMS.fm.REC.1395.52
Health conditions studied
1
Description of health condition studied
neonatal respiratory distress
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Neonatal respiratory distress reduction
Timepoint
1-3 days after neonatal birth
Method of measurement
RDS will be diagnosed according to clinical criteria (tachypnea, subarachnoid retraction, grunting, groaning) and radiological criteria (volume reduction , Ground-glass, fading border of diaphragm and heart shadow).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group mothers will receive vitamin D injections(50,000 IU) 72 hours before childbirth.
Category
Treatment - Drugs
2
Description
Control group: No intervention including injection of Vitamin D will be done on mothers.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Hassan Boskabadi
Street address
1st Floor,Pediatric Ward, Ghaem Hospital, Ahmad Abad Avenue,
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
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
1st Floor,Pediatric Ward, Ghaem Hospital, Ahmad Abad Avenue,
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
Boskabadih@mums.ac.ir
Grant name
Grant code / Reference number
941645
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
Hasan Bosk abadi
Position
professore of pediatrics
Latest degree
Subspecialist
Other areas of specialty/work
neonatal perinatal medicine
Street address
1st Floor,Pediatric Ward, Ghaem Hospital, Ahmad Abad Avenue, Mashhad, Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
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
professore of pediatrics
Latest degree
Subspecialist
Other areas of specialty/work
neonatal perinatal medicine
Street address
1st Floor,Pediatric Ward, Ghaem Hospital, Ahmad Abad Avenue, Mashhad, Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
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
Hasan Bosk abadi
Position
professore of pediatrics
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
1st Floor,Pediatric Ward, Ghaem Hospital, Ahmad Abad Avenue, Mashhad, Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
Boskabadih@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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