The aim of this study is the comparison of the effectiveness of vitamin D vs. placebo in preterm newborn with respiratory distress syndrome
Design
A phase 2, randomized, double-blind, placebo-controlled clinical trial with 3 parallel groups in 96 patients. The Randomization sequence will be generated by the free website at http://www.randomization.com.
Settings and conduct
96 preterm newborns between 28-34 weeks gestation with respiratory distress syndrome, referring to Neonatal Intensive Care Unit (NICU), Imam Khomeini Hospital, Ahvaz will be allocated in one of three groups based on blocked randomization. The Control group receives the standard care of RDS with placebo, Intervention group 1 receives vitamin D in the dose of 400 IU/Day with the standard care of RDS, Intervention group 2 receives vitamin D in the dose of 800 IU/Day with the standard care of RDS. The physician evaluates the clinical status of patients and the nurse is not aware of the intervention that patients receive. Three groups will be compared based on mortality rate and hospitalization duration on the first and last day of hospitalization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Preterm newborn between 28-34 weeks gestation with respiratory distress syndrome; admitted to NICU
Exclusion criteria: Neonates with neonatal sepsis; hypoxia; congenital disorders; feeding intolerance; newborn of diabetic mother
Intervention groups
The cases allocate into three groups, the control group receives the standard care of RDS with placebo, Intervention group 1 receives vitamin D in the dose of 400 IU/Day with the standard care of RDS, Intervention group 2 receives vitamin D in the dose of 800 IU/Day with the standard care of RDS.
Main outcome variables
Mortality rate; hospitalization duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170307032933N4
Registration date:2021-06-22, 1400/04/01
Registration timing:prospective
Last update:2021-06-22, 1400/04/01
Update count:0
Registration date
2021-06-22, 1400/04/01
Registrant information
Name
Pedram Nazari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 7705
Email address
nazari.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-28, 1400/04/07
Expected recruitment end date
2021-09-29, 1400/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of Vitamin D َAdministration in the Treatment of Preterm Neonates with Respiratory Distress Syndrome
Public title
Effect of vitamin D in respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm newborn between 28-34 weeks gestation
Preterm newborn admitted to NICU
Preterm newborn with the confirmed respiratory distress syndrome based on clinical and chest X-ray findings
Exclusion criteria:
Neonates with neonatal sepsis
Neonates with hypoxia
Neonates with congenital disorders
Neonates with feeding intolerance
Newborn of diabetic mother
Age
From 6 months old to 8 months old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients into therapeutic or control groups will be done by Block Balanced Randomization (BBR) method by using blocks with size of 6. Individuals are the randomization unit. The Randomization sequence will be generated by using the free website at http://www.randomization.com. Allocation concealment will be done by assigning unique codes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Parents of premature infants know that their newborns are enrolled in an investigation that is aimed to evaluate the vitamin D effect on the respiratory distress syndrome, but they are not informed that they receive placebo or vitamin D. The physician who evaluates the clinical status of patients and the nurse are not aware of the intervention that patients receive. The drug and placebo in each group are exactly in the same form and packages. The packages are distinguished only by mentioning the number and the list of numbers will be at the disposal of the statistical consultant and then the data will be analyzed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Golestan Hospital
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2021-06-01, 1400/03/11
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.050
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Mortality rate
Timepoint
Within admission period
Method of measurement
Reports of nurses or physicians
Secondary outcomes
1
Description
Hospitalization duration
Timepoint
The first day and the last day of the patient's hospitalization
Method of measurement
Patient record
Intervention groups
1
Description
Intervention group 1: Daily 400 IU (1 cc) of vitamin D Drop (1000 IU, Alhavi company, Iran) for three weeks is administrated.
Category
Treatment - Drugs
2
Description
Intervention group 2: Daily 800 IU (1 cc) of vitamin D Drop (2000 IU, Alhavi company, Iran) for three weeks is administrated.
Category
Treatment - Drugs
3
Description
Control group: Daily 1 cc of placebo drop (Alhavi company, Iran) for three weeks is administrated.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal Intensive Care Unit of Imam Khomeini Hospital
Full name of responsible person
Arash Malekian
Street address
Imam Khomeini Hospital, Azadegan Street, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 7705
Email
malekianarash@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadimoghadam
Street address
Vice Chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences, Daneshgahi Settlements, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 4355 4063
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Arash Malakian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Neonatology, Imam Khomeini Hospital, Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
0098 61 3367543
Email
malekianarash@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Arash Malakian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Neonatology, Imam Khomeini Hospital, Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
0098 61 3367543
Email
malekianarash@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Jamshid Safdarian
Position
Neonatology fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Department of Neonatology, Imam Khomeini Hospital, Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
0098 61 3367543
Email
jamshidsafdarian@yahoo.com
Web page address
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
Undecided - It is not yet known if there will be 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
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