Protocol summary

Summary
The purpose of this study is to investigate the effect of intratracheal administration of Furosemide, Salbutamol, or a mixture of both with Surfactant on the clinical course of premature infants with respiratory distress syndrome.Inclusion criteria: gestational age less than 34 weeks; respiratory distress syndrome and exclusion criteria: body weight less than 1000 g; congenital anomalies; birth trauma and perinatal asphyxia. Newborns with body weight less than 1500g with respiratory distress syndrome initially would be treated with NCPAP and 50% oxygen concentration. Base on the arterial blood gas analysis the newborns would be intubated, surfactant given and NCPAP continue or mechanical ventilation considered. Newborns with body weight greater than 1500g with respiratory distress syndrome initially would be treated with 40% oxygen concentration. If respiratory distress increases, NCPAP would be started and oxygen concentration increased up to 50%. Unresponsive patients would be intubated, surfactant given and NCPAP continue or mechanical ventilation considered. This is a double blind pilot study and 48 premature newborns with respiratory distress syndrome who need to surfactant would be enrolled in the study. Base on the table of random numbers beside of surfactant one of the following compound would be administered intratracheally: A (Furosemide), B (Normal Saline), C (Salbutamol), D (Furosemide and Salbutamol). Duration of NCPAP treatment, need to mechanical ventilation and its duration, duration of need to oxygen and days of admission would be assessed between four groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014072714215N1
Registration date: 2014-08-13, 1393/05/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-13, 1393/05/22
Registrant information
Name
Masoud Dehdashtian
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1221 6503
Email address
dehdashtian@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Intratracheal Furosemide, Salbutamol, or a Mixture of Both with Surfactant on Clinical Course of Premature Infants with Respiratory Distress Syndrome
Public title
The Effect of Intratracheal Furosemide, Salbutamol, or a Mixture of Both with Surfactant on Clinical Course of Neonatal Respiratory Distress Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: newborns with gestational less than 34 weeks; respiratory distress syndrome and Exclusion criteria: birth weight less than 1000gr; birth trauma; congenital anomalies; birth asphyxia; transported patients
Age
From 1 day old to 1 month old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan
City
Ahvaz
Postal code
Approval date
2014-03-15, 1392/12/24
Ethics committee reference number
ajums.REC.1392.340

Health conditions studied

1

Description of health condition studied
Respiratory Distress Syndrome
ICD-10 code
P00-P96
ICD-10 code description
certain conditions originating in the perinatal period

Primary outcomes

1

Description
Clinical course
Timepoint
Discharge from hospital
Method of measurement
Hours and days that patients needing to respiratory therapy

Secondary outcomes

1

Description
Death
Timepoint
Cardiorespiratory arrest
Method of measurement
Absent of heart beat and respiratory movement

Intervention groups

1

Description
Furosemide 1mg.kg.body weight accompanied Surfactant would be infused in trachea. if needing to repeated dose of Surfactant, Furosemide also would be repeated.
Category
Treatment - Drugs

2

Description
Salbutamol 0.2mg.kg.body weight accompanied Surfactant would be infused in trachea. if needing to repeated dose of surfactant, Salbutamol also would be repeated
Category
Treatment - Drugs

3

Description
Furosemide 1mg.kg.body weight and Salbutamol 0.2 mg.kg.body weight accompanied Surfactant would be infused in trachea. if needing to repeated dose of surfactant, Furosemide and Salbutamol also would be repeated
Category
Treatment - Drugs

4

Description
Normal Saline 0.5ml.kg.body weight as placebo accompanied Surfactant would be infused in trachea. if needing to repeated dose of Surfactant, Normal Saline also would be repeated
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dehdashtian Masoud, Neonatologist, Associated Professor
Street address
Azadegan
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Saki Nader
Street address
Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Medical Faculty
Full name of responsible person
Dehdashtian Masoud
Position
Associate Professor,Head of Neonatal Ward
Other areas of specialty/work
Street address
Imam Hospital
City
Ahvaz
Postal code
Phone
+98 61 1221 6501
Fax
Email
dehdashtian@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medical Faculty
Full name of responsible person
Dehdashtian Masoud
Position
Associate Professor
Other areas of specialty/work
Street address
Imam Hospital
City
Ahvaz
Postal code
Phone
+98 61 1221 6501
Fax
Email
dehdashtian@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Medical Faculty
Full name of responsible person
Dehdashtian Masoud
Position
Neonatologist, Associate Professor
Other areas of specialty/work
Street address
Imam Hospital
City
Ahvaz
Postal code
Phone
+98 22 16501
Fax
Email
dehdashtian@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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