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 January 2019 and September 2019
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Pregnant woman with gestational age less than 37 weeks will be included the study and those mothers with drug abuse will be excluded .
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
Acronym
IRCT registration information
IRCT registration number:IRCT20190814044529N1
Registration date:2020-01-21, 1398/11/01
Registration timing:retrospective
Last update:2020-01-21, 1398/11/01
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
empty
Actual recruitment end date
empty
Trial completion date
empty
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:
Pregnant woman with gestational age less than 37 weeks
Exclusion criteria:
mothers with drug abuse
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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