Protocol summary

Study aim
Investigating the effectiveness of magnesium sulfate prophylaxis to prevent hospital sepsis among premature infants with respiratory distress syndrome.
Design
A clinical trial study that is both superior and parallel, using two intervention and control groups. Random allocation software was used to create a list of random blocks with variable sizes of 4 and 6, each block having an equal number of groups. The package will be used to conceal allocations using envelopes. The envelopes will have their numbers and be arranged in order. Then, for each patient entered into the study, an envelope will be opened and based on the contents of the envelope, they will be entered into one of the two control or intervention groups.
Settings and conduct
In the neonatal intensive care unit, serum magnesium levels are tested for premature babies aged 28 to 34 weeks, who weigh 1200 to 2000 grams and have respiratory distress syndrome 24 hours after birth. The control group received the usual treatment, while in the intervention group, intravenous magnesium sulfate was prescribed for 5 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 28 to 34 weeks premature newborns with a weight of 1200 to 2000 grams with respiratory distress syndrome. Inclusion in the study is contingent on taking magnesium sulfate during pregnancy, neonatal anomaly, chorioamnionitis, and underlying maternal disease.
Intervention groups
The intervention group took intravenous magnesium sulfate for 5 days, and the magnesium level was rechecked the day after the treatment. The control group received nutrition and, if necessary, routine TPN that did not contain magnesium.
Main outcome variables
The duration of assisted ventilation (whether it involves invasive or non-invasive ventilation) and the amount of time needed to receive complete oral nutrition (equivalent to 180 cc per kilogram of body weight).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080901001162N28
Registration date: 2024-07-20, 1403/04/30
Registration timing: registered_while_recruiting

Last update: 2024-07-20, 1403/04/30
Update count: 0
Registration date
2024-07-20, 1403/04/30
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-20, 1403/02/31
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic Magnesium Sulfate and Sepsis in Preterm neonates with Respiratory Distress Syndrome
Public title
Prophylactic Magnesium Sulfate and Sepsis in Preterm neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature newborns 28 to 34 weeks weighing 1200 to 2000 grams with respiratory distress syndrome Informed consent
Exclusion criteria:
Intake of magnesium sulfate by the mother during pregnancy Neonatal anomaly Chorioamnionitis Mother's disease
Age
From 1 day old to 30 days old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 194
Randomization (investigator's opinion)
Randomized
Randomization description
A list of random blocks with variable sizes of 4 and 6 is created by using random allocation software. Each block has an equal number of groups and a number is assigned to it. The order of contents in each block is determined by the balanced distribution of people in the studied groups. Upon each patient's visit, one of the blocks is randomly selected and, according to the contents, the patient is assigned to one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The analyst and the patient will be unaware of the intervention and control groups. Using random allocation software, a list of random blocks with variable sizes of 4 and 6 is designed, each block contains an equal number of groups, and a number is assigned to each block. The order of the contents of each block includes the balanced allocation of people in are the studied groups. With the visit of each patient, one of the blocks is randomly selected and according to the order of the contents, the patient is assigned to one of the groups.
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
Qreishi Bul, Daneshgah Ave, Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
3791331697
Approval date
2024-04-26, 1403/02/07
Ethics committee reference number
IR.MUMS.REC.1403.043

Health conditions studied

1

Description of health condition studied
respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
The days requiring assisted ventilation ( need for invasive or non-invasive assisted ventilation)
Timepoint
During the hospitalization of the newborn
Method of measurement
daily It is done only through a mask that is firmly placed on the face.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For five days, half a milliequivalent of magnesium sulfate per kilogram of body weight is given intravenously.
Category
Treatment - Drugs

2

Description
Control group: Their diet consists of daily food and, if needed, routine TPN that does not contain magnesium.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Ashraf Mohammadzadeh
Street address
NICU-Imam Reza Hospital- Mashhad-Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
mohamadzadeha@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Qureishi Bul, Daneshgah Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
mohamadzadeha@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
Dr Ashraf Mohammadzadeh
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NICU- Imam Reza Hospital- Mashhad-Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
Mohamadzadeha@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ashraf Mohammadzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NICU-Imam Reza Hospital- Mashhad-Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
mohamadzadeha@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ashraf Mohammadzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NICU-Imam Reza Hospital-Mashhad-Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
0098-051-385212121
Email
mohamadzadeha@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data can be accessible through an email to the corresponding author
Under which criteria data/document could be used
Data will be available for researchers in universities and other scientific institute
From where data/document is obtainable
After sending a request email to the corresponding author data will be sent in 1 month. email
What processes are involved for a request to access data/document
Carrying out analysis on data is permitted. This process involves gathering information using a suitable software or tool that allows statisticians and data scientists to explore the data and find patterns in it. Then, based on that information and data, you can make a decision or draw a final conclusion.
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