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 from March 2020 to November 2020
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
Acronym
IRCT registration information
IRCT registration number:IRCT20110807007244N5
Registration date:2020-12-01, 1399/09/11
Registration timing:retrospective
Last update:2020-12-01, 1399/09/11
Update count:0
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
2020-02-20, 1398/12/01
Expected recruitment end date
2020-10-30, 1399/08/09
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
91766-99199
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
91766-99199
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
91766-99199
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