We performed this study to evaluate the effect of intratracheal administration of N-acetylcysteine (NAC) on clinical status and adverse effect of intubation in neonates with RDS. This double-blind randomized controlled trial was conducted on 65 neonates admitted to NICU ward of Rasoul-Akram hospital, Tehran, Iran. They were mechanically ventilated with clinical and radiological evidence of chronic lung disease and respiratory distress syndrome. They were divided into 2 groups: one consisted of 29 neonates receiving tracheal administration of 5% NAC and the other consisted of 36 neonates receiving saline placebo. Number of tracheal tube exchange (time to exchange) and hemorrhage were recorded in groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810012420N2
Registration date:2010-02-10, 1388/11/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-10, 1388/11/21
Registrant information
Name
Seyed-Mohammad Fereshtehnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2275 6035
Email address
mohammad@stu.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2003-03-20, 1381/12/29
Expected recruitment end date
2005-03-20, 1383/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
N-acetylcysteine for endotracheal tube patency in neonates: A randomized clinical trial
Public title
The effect of N-acetylcystein in outcome and adverse effects of intubation in neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Neovates > 1200 gram hospitalized in NICU of Rasoul Akram hospital and needed to be intubated and mechanically ventilated based on standard protocols. Exclusion Criteria: Neonates with major anomalies or cyanotic cardiac diseases, neonates who ere intubated at the beginning of their hospitalization, neonates with pneumothorax at the time of hospitalization or intubation, massive hemorrhage, neonates who were extubated before 24 hours or dead before this time
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
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
Ethics Committee of Iran University of Medical Sciences and Health services
Street address
Iran University of Medical Sciences and Health services, Hemmat highway
City
Tehran
Postal code
14155-5983
Approval date
2006-07-10, 1385/04/19
Ethics committee reference number
2217
Health conditions studied
1
Description of health condition studied
Respiratoty Distress Syndrome of neonates
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
The duration of first intubation until exchange of endotracheal tube due to mucus plug retention
Timepoint
every 6 hours
Method of measurement
Tube cleaning with drugs in order to make sure that it's open
Secondary outcomes
1
Description
number of endotracheal tube obstruction and replacement due to mucus plug
Timepoint
every 6 hours
Method of measurement
cleaning of the endotracheak tube to make sure that it's open
2
Description
duration of intubation
Timepoint
every day
Method of measurement
observation
3
Description
events those may be related to the new drug including apnoea and bradycardia, hypotension, pulmonary haemorrhage
Timepoint
every 6 hours
Method of measurement
monitoring of the patient
4
Description
death
Timepoint
every 6 hours
Method of measurement
control of vital signs
Intervention groups
1
Description
cleaning of the endotracheal tube every 6 hours with 2 mililiter of N-acetylsucteine solution
Category
Other
2
Description
cleaning of the endotracheal tube every 6 hours with 2 mililiter of normal saline solution
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences and Health Services
Full name of responsible person
Azita Zabihi
Street address
Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences and Health Services
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
Iran University of Medical Sciences and Health Servuces