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The effect of N-acetylcystein in outcome and adverse effects of intubation in neonates

N-acetylcysteine for endotracheal tube patency in neonates: A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT138810012420N2
Enrollment
65
Registered
2010-02-10
Start date
2003-03-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratoty Distress Syndrome of neonates. Respiratory distress syndrome of newborn

Interventions

Intervention 1: cleaning of the endotracheal tube every 6 hours with 2 mililiter of N-acetylsucteine solution. Intervention 2: cleaning of the endotracheal tube every 6 hours with 2 mililiter of norma
Placebo
cleaning of the endotracheal tube every 6 hours with 2 mililiter of N-acetylsucteine solution
cleaning of the endotracheal tube every 6 hours with 2 mililiter of normal saline solution

Sponsors

Vice chancellor for research, Iran University of Medical Sciences and Health Services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.;Duration of intubation. Timepoint: every day. Method of measurement: observation.;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.;Death. Timepoint: every 6 hours. Method of measurement: control of vital signs.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyed Mohammad Fereshteh Nejad

Iran University of Medical Sciences and Health Servuces

mohammad@stu.iums.ac.ir ; sfm681@yahoo.com+98 21 2275 6035

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026