Protocol summary

Summary
This interventional study- outcome based- aimed to assess the impact of nursing care educational program on the outcome of mechanical ventilation in infants undergoing mechanical ventilation in the NICU, and secondary objectives is comparison of the frequency of the most common consequences of mechanical ventilation in neonate, including ventilator-associated respiratory infections, bronchopulmonary dysplasia, pulmonary hemorrhage, retinopathy of prematurity, etc. Research environment is NICU of Comprehensive Women's Hospital (Mirza kouchak Khan) in Tehran. The study population is all infants admitted to the intensive care unit of this hospital and undergoing ventilation from Farvardin 1392 to Farvardin 1393. Inclusions Criteria are admitted discharged or died infants undergoing mechanical ventilation in this interval. All newborns undergoing mechanical ventilation due to asphyxia, congenital anomalies and pulmonary hypoplasia, who have less than 6 hours of mechanical ventilation, and Mid-treated infants who have been separated for any reason from ventilator, have been Excluded. This project is a four-step method. Firstly, to collect demographic information and the consequences caused by the use of mechanical ventilation from infants admitted to the NICU. In the second step (the start of the intervention) guidelines for the care of the infant undergoing ventilation, are provided for NICU nurses. In the third step, Participatory and Questions and Answers training session about care will be held by researchers and professors during specific hours. The final step of the study is conducted, with a time interval of 1 month after completion of the education. In this point, neonatal records infants are investigated to collect information for 6 months. Finally, by comparing the data obtained through statistical tests, results will be announced. The main variables in this study include educational program of nursing care and outcome of mechanical ventilation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013101615040N1
Registration date: 2014-02-06, 1392/11/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-06, 1392/11/17
Registrant information
Name
Parichehr Talori
Name of organization / entity
School of Nursing and Midwifery, Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 5560
Email address
p-talori@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect on the outcome of mechanical ventilation in neonates.
Public title
Evaluation of the impact of nursing educational on outcomes among hospitalized neonates under mechanical ventilation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included infants admitted; discharged ; died in hospital neonatal intensive care unit of a comprehensive women who have been mechanically ventilated. Exclusion criteria included infants who because of asphyxia; congenital malformation complex; hypoplasia of lung, infants less than 6 hours of mechanical ventilation as well as babies in the middle of treatment for any reason be removed from the ventilator
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
Tehran University of Medical Sciences, Quds Street, Keshavarz Boulevar
City
Tehran
Postal code
Approval date
2013-08-21, 1392/05/30
Ethics committee reference number
130/1076 /د/92

Health conditions studied

1

Description of health condition studied
Broncoho pulmonary dysplasia
ICD-10 code
J98.4
ICD-10 code description
lung diseases

2

Description of health condition studied
Ventilator Associated Pneumonia
ICD-10 code
J69.0
ICD-10 code description
Diseases of the respiratory system

3

Description of health condition studied
Pulmonary hemorrhage
ICD-10 code
P26.8
ICD-10 code description
Pulmonary hemorrhage

4

Description of health condition studied
Pneumothorax
ICD-10 code
J98.1
ICD-10 code description
lung diseases

Primary outcomes

1

Description
Nursing Education Program
Timepoint
After Edite booklet and deliver to ward
Method of measurement
During classes

2

Description
Outcomes of mechanical ventilation
Timepoint
Before and after training
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Gestational age
Timepoint
Before and after training
Method of measurement
Demographic Information Questionnaire

2

Description
sex
Timepoint
Bifore and after training
Method of measurement
Demographic Information Questionnaire

3

Description
Birth weight
Timepoint
Before and after training
Method of measurement
Demographic Information Questionnaire

4

Description
Apgar score
Timepoint
Before and after training
Method of measurement
Demographic Information Questionnaire

5

Description
Mothers Diseases
Timepoint
Before and after training
Method of measurement
Demographic Information Questionnaire

6

Description
Type of delivery
Timepoint
Before and after training
Method of measurement
Demographic Information Questionnaire

7

Description
Onset of mechanical ventilation
Timepoint
Before and after training
Method of measurement
Demographic Information Questionnaire

8

Description
Length of stay
Timepoint
Before and after training
Method of measurement
Questionnaire

9

Description
Respiratory problems
Timepoint
Before and after training
Method of measurement
Questionnaire

10

Description
Other respiratory problems
Timepoint
Before and after training
Method of measurement
Questionnaire

Intervention groups

1

Description
Provide guidelines for infant care, including washing hands before and after caring for infants, temperature control, nutrition, respiratory care involves fixing endotracheal tube care, condition, giving good suction, oxygenation, ill deal with infants under ventilator is prepared and placed in the neonatal intensive care unit nurses and multi-session courses in the form of participation and question and answer sessions about where noted.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Women's Hospital
Full name of responsible person
The profiles neonate
Street address
North Nejatollahi Street, Karim Khan Zand Street, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Jila Mirlashari
Street address
Tehran University of Medical Sciences, Quds Street, Keshavarz Boulevar
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Parichehr Talori
Position
Neonatal Intensive Care Nursing Graduate Student
Other areas of specialty/work
Street address
8 Golestan dormitories، Ahmadi Alley،TheIntersection of North Kargar Street، Keshavarz Bolvar، Tehran
City
Tehran
Postal code
Phone
+98 21 8899 4106
Fax
Email
talorip@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parichehr Talori
Position
Neonatal Intensive Care Nursing Graduate Student
Other areas of specialty/work
Street address
8 Golestan dormitories، Ahmadi Alley، The Intersection of North Kargar Street، Keshavarz Bolvar، Tehran
City
Tehran
Postal code
Phone
+98 21 8899 4106
Fax
Email
talorip@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parichehr Talori
Position
Neonatal Intensive Care Nursing Graduate Student
Other areas of specialty/work
Street address
8 Golestan dormitories، Ahmadi Alley، The Intersection of North Kargar Street، Keshavarz Bolvar، Tehran
City
Tehran
Postal code
Phone
+98 21 8899 4106
Fax
Email
talorip@yahoo.com
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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