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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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).
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
1
-
Sponsor
-
-
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
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
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable