Determining the effect of restricting serum fluids on infants with transient tachypnea in Ba'ath Hospital, Sanandaj in 1401
Design
A double-blind clinical trial is a double black randomized clinical trial.
Settings and conduct
A double-blind clinical trial is a double black randomized clinical trial. The total amount of fluids in the intervention and comparison groups will be 65 milliliters/kg and 80 milliliters/kg for term and late preterm infants, respectively. All infants will be weighed twice daily to assess hydration status. In addition, urine volume, urine specific gravity, electrolyte level and arterial blood gas will be checked daily. In addition to these cases, the result of the treatment will be reported and compared to the time of hospitalization and respiratory support in the two groups. Finally, the recovery rate and effectiveness of two treatment methods in two groups are compared.
Participants/Inclusion and exclusion criteria
1. Premature, late, full-term babies with tachypnea (number of respirations more than 60)
2. Radiological signs of transient tachypnea or signs of transient tachypnea with a normal chest radiograph (respiratory distress score based on the Silverman scoring system 4) and hospitalization within the first 6 hours after birth.
Intervention groups
In this study, 65 ml of 10% dextrose solution per kilogram of body weight will be given to late preterm and full-term infants in the intervention group. In the following days, if no discrepancy is observed, the daily dose of 20 ml of fluids will be added to the previous amount. until the total fluid intake reaches 150 ml/kg for term and late preterm infants. For infants who will undergo radiant heating or phototherapy, 10% of total fluid will be added for insensible water loss.
Investigating the effect of fluid restriction on infants with transient tachypnea
Public title
Investigating the effect of fluid restriction on infants with transient tachypnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants, post term, or term infants with tachypnea (respiratory rate greater than 60) may exhibit these characteristics.
Infants who have transient radiological signs of tachypnea.
Infants without radiological signs who have transient clinical symptoms of tachypnea and have been hospitalized within the first 6 hours after birth.
Exclusion criteria:
Infants who have congenital abnormalities.
Infants who have other causes of respiratory distress, such as meconium aspiration syndrome, persistent pulmonary hypertension of the newborn, congenital diaphragmatic hernia, or surgical causes.
Infants who are suspected of having sepsis.
Infants who have asphyxia.
Infants who are in shock.
Infants who have a history of birth trauma.
Infants who have positive blood culture.
Infants who receive surfactant therapy during treatment.
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study will be conducted using Balanced Block Randomization. It will be performed by creating blocks of four, evenly distributed between the intervention and control groups. Each block will be assigned single-digit codes, and ultimately, random numbers will be selected from the designated numbers using a random number table. The individuals will be allocated to the two groups according to the assigned blocks. This approach will also assist in allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the design is double-blind, where the infants under investigation are divided into two groups, and their families and clinical caregivers are also blind to the intervention and the intervention conditions. In order to perform blinding, the serums are kept in dark-colored and identical vials labeled A and B, and they are administered to the infants through a nurse who is completely blind to the type of serum, using a serum set,
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
661776796
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.MUK.REC.1402.005
Health conditions studied
1
Description of health condition studied
Transient neonatal tachycardia
ICD-10 code
P22.1
ICD-10 code description
Transient tachypnea of newborn
Primary outcomes
1
Description
Hospitalization days
Timepoint
upon discharge
Method of measurement
Refer to the patient's medical record
2
Description
Electrolyte and arterial blood gas levels
Timepoint
Upon arrival and 24 hours later
Method of measurement
It is performed on a blood sample taken from an artery or radial artery or other artery, and during it, the percentage of dissolved gases in the blood as well as the pH of the blood is calculated.
3
Description
The respiratory distress level
Timepoint
Upon arrival and 24 hours later
Method of measurement
Observation and documentation by a trained NICU nurse.
Secondary outcomes
1
Description
Respiratory rate
Timepoint
upon admission and 24 hours later.
Method of measurement
Documentation by a trained NICU nurse.
2
Description
The level of respiratory support.
Timepoint
upon admission and 24 hours later.
Method of measurement
Documentation by a trained NICU nurse.
3
Description
weight gain
Timepoint
upon admission and 24 hours later.
Method of measurement
The amount of weight gain measured with a digital scale.
Intervention groups
1
Description
Intervention group: The number of 60 babies with respiratory distress in the intravenous fluid restriction group is 65 cc/Kg on the first day and a daily increase of 10 cc/Kg.
Category
Treatment - Other
2
Description
Control group: The number of 60 babies with respiratory distress in the control group, where intravenous fluids are added daily at 20 ml/kg to the previous fluids
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Sirus Hematpour
Street address
Keshavarz Street
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3328 5911
Email
Info@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Abidar street
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3322 9494
Email
Info@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
1
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
Sanandaj University of Medical Sciences
Full name of responsible person
Siros Hemmatpour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 4, Piroozi Alley, jamejam Ave, Sanandaj, iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3362 7751
Fax
Email
dr.siroshemmatour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Siros Hemmatpour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 4, Piroozi Alley, jamejam Ave, Sanandaj, iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3362 7751
Fax
Email
dr.siroshemmatour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Siros Hemmatpour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No. 4, Piroozi Alley, jamejam Ave, Sanandaj, iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3362 7751
Fax
Email
dr.siroshemmatour@yahoo.com
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
Yes - There is 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
Yes - There is a plan to make this available
When the data will become available and for how long
Yes - There is a plan to make this available
To whom data/document is available
Yes - There is a plan to make this available
Under which criteria data/document could be used
Yes - There is a plan to make this available
From where data/document is obtainable
Yes - There is a plan to make this available
What processes are involved for a request to access data/document