Determining and comparing the percentage of neonatal with asphyxia before, during and after the intervention
Design
This study has two groups, including learners (midwives) who are trained and a group (asphyxiated infants) who measure the extent and severity of neonatal disease based on the performance of learners (midwives) and the sampling method is census.
Settings and conduct
The study was performed in Iran Hospital of Iranshahr University of Medical Sciences on the extent and severity of asphyxia in infants that The statistics of asphyxia neonates are recorded in three 6-month stages and the diagnosis is made based on clinical examination and the results of neonatal arterial blood samples.
Participants/Inclusion and exclusion criteria
Infants diagnosed with asphyxia according to the guideline will be included in the study.
Intervention groups
Students who obtain the required score of the questionnaire and OSCE after the workshop and are engaged in the delivery room, operating room and triage departments of the emergency department will be included in the study.
Infants diagnosed with asphyxia according to the guideline will be included in the study.
Main outcome variables
AThe degree of asphyxia of infants and the Apgar score at birth of infants with asphyxia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220211053998N1
Registration date:2022-03-02, 1400/12/11
Registration timing:registered_while_recruiting
Last update:2022-03-02, 1400/12/11
Update count:0
Registration date
2022-03-02, 1400/12/11
Registrant information
Name
Ferdows Bameri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3721 1490
Email address
bameriferdows@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-21, 1400/12/02
Expected recruitment end date
2023-08-24, 1402/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Education based on Helping Babies Breathe Workshop Program for Midwives on the Neonatal asphyxia
Public title
The Effect of Education based on Helping Babies Breathe Workshop Program for Midwives on the Neonatal asphyxia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Infants with Apgar Scores less than 7 in the fifth minute of life
Infants with a Potential Hydrogen(PH) less than 7 on umbilical Artery Blood Gas (ABG) Analysis in the first hour after Birth
Infants with a Base excess (BE) less than -12 in Umbilical ABG Analysis in the first hour after Birth
Diagnosis of Hypoxic Ischemic Encephalopathy (HIE) in the first 3 Days after Birth
Multiple Organ Failure associated with HIE
Birth Age more than 34 Weeks
Born in Iran Hospital in Iranshahr
Exclusion criteria:
Genetic Syndromes or Congenital Anomalies of the Central Nervous System at Birth
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Iranshahr University of Medical Sciences
Street address
No. 46, Imam Khomeini St., Iranshahr University of Medical Sciences
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9916643535
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
IR.IRSHUMS.REC.1400.019
Health conditions studied
1
Description of health condition studied
Asphyxia
ICD-10 code
R09.01
ICD-10 code description
Asphyxia
Primary outcomes
1
Description
Percentage of infants with asphyxia
Timepoint
Before intervention, during intervention, after intervention
Method of measurement
ABG test, Apgar score, clinical signs as determined by the treating physician or MRI
2
Description
Degrees of asphyxia in infants
Timepoint
Before intervention, during intervention, after intervention
Method of measurement
ABG test, Apgar score, clinical signs as determined by the treating physician or MRI
3
Description
Mean Apgar score of newborns
Timepoint
Before intervention, during intervention, after intervention
Method of measurement
Physical examination
Secondary outcomes
1
Description
The average score of midwives participating in the continuing education program to helping babies breathe in the workshop
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Questionnaire 18 questions to assess the knowledge and OSCE tests of the program to helping babies breathe
Intervention groups
1
Description
Intervention Group 1: Babies with asphyxia at birth: In this plan, in three consecutive periods of 6 months, the statistics of infants with asphyxia are collected according to the inclusion criteria (arterial blood test of the umbilical cord of newborns at birth, which is part of the hospital routine and neonatal Apgar score) in 6 months Second, midwives involved in birth, neonatal resuscitation program are trained and reminded 4 times according to a specific program, but in the first and third 6 months, no intervention is made in the field of midwifery education. Finally, the results and percentage of infants with asphyxia in these three time periods are compared and the effect of the outcome of continuing education is measured.
Category
Early detection
2
Description
Intervention Group 2: Midwives: In the second 6 months of collecting statistics on asphyxiated infants, at the beginning of the first, third, fifth and sixth months, all midwives involved in birth are taught in person in the form of a workshop, neonatal resuscitation program and the effect of continuing education on educational outcomes (Statistics of asphyxiated infants) is measured (statistics of infants with asphyxia in the first 6 months, second 6 months and third 6 months are compared).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran hospital
Full name of responsible person
Ferdows Bameri
Street address
Iran Hospital, 4 km of Bampour Road
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914665466
Phone
+98 54 3721 2461
Email
nurse2012b.ferdows@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Fatemeh Azarkish
Street address
No. 46, Imam Khomeini St., Iranshahr University of Medical Sciences
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9916643535
Phone
+98 54 3721 3891
Email
Irshums@irshums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranshahr University of Medical Sciences
Proportion provided by this source
100
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
Iranshahr University of Medical Sciences
Full name of responsible person
Ferdows Bameri
Position
Non-faculty nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iran Hospital, 4 km of Bampour Road
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914665466
Phone
+98 54 3721 1490
Fax
Email
bameriferdows@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Ferdows Bameri
Position
Non-faculty nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iran Hospital, 4 km of Bampour Road
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914665466
Phone
+98 54 3721 2461
Fax
Email
bameriferdows@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Ferdows Bameri
Position
Non-faculty nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iran Hospital, 4 km of Bampour Road
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914665466
Phone
+98 54 3721 2461
Fax
Email
bameriferdows@bums.ac.ir
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
Undecided - It is not yet known if there will be 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