The effect of the Helping Babies Survive program on Essential newborn care improvment in Beheshti Hospital affiliated to Isfahan University of Medical Sciences at 2019
Determination and Comparison of Relative Frequency of Temperature and Breathing Rate in 15-30-60 Minutes After Birth, Time of Clamping of the Baby Cord, Average Score of Infant Breastfeeding, at the End of First Hour, Average Score of Infant Breastfeeding, At the end of the first 24 hours in the control and intervention groups.
Design
The study has a control and intervention group with a sample size of at least 100.
Settings and conduct
Hospital staff will be trained in the infant survival program, and the ascetic will be trained before and after training, and then the lactation success checklist will be completed at the end of 1 hour and 24 hours of infants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Parent consent to participate in the study - Newborn weighing more than 1500 g - Birth with normal vaginal delivery - Healthy newborn without congenital abnormalities and no delivery complications - No mental illness and addiction File
Exclusion criteria for maternal and neonatal study: Maternal incidence of postpartum complications: thrombophlebitis, periodontal infection, pulmonary embolism, severe bleeding-hospitalization or neonatal death during the study
Intervention groups
In the control group, routine care is performed and in the intervention group, the care is based on the infant survival plan.
Main outcome variables
Evaluate the impact of implementing a newborn survival assistance program and selecting the appropriate program to improve basic neonatal care
General information
Reason for update
Acronym
خالی
IRCT registration information
IRCT registration number:IRCT20191212045712N1
Registration date:2019-12-24, 1398/10/03
Registration timing:prospective
Last update:2019-12-24, 1398/10/03
Update count:0
Registration date
2019-12-24, 1398/10/03
Registrant information
Name
najme ajoodanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7576
Email address
n.ajoodanian@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the Helping Babies Survive program on Essential newborn care improvment in Beheshti Hospital affiliated to Isfahan University of Medical Sciences at 2019
Public title
The effect of the Helping Babies Survive program on Essential newborn care improvment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Infants weighing over 1500 grams
Exclusion criteria:
Babies weighing less than 1500 grams
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)
Randomized
Randomization description
Randomized control
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
sofe Blvd Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673465
Approval date
2019-11-02, 1398/08/11
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.411
Health conditions studied
1
Description of health condition studied
This study has no pathogenesis.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improve basic baby care
Timepoint
Breastfeeding Success Checklist End of 1 Hour 24 Hours of Birth - Time of Cord Clamping During First Minutes of Birth - Temperature and Breathing at 15-30-60 Minutes
Method of measurement
Checklist-Stopwatch-Thermometer
Secondary outcomes
1
Description
The variable has no secondary consequence
Timepoint
The variable has no secondary consequence
Method of measurement
The variable has no secondary consequence
Intervention groups
1
Description
Intervention group: Intervention group: neonates born in maternity ward with trained personnel caring for infant survival program
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
This study has no pathogenesis
Full name of responsible person
The Najam of the Adudians
Street address
Isfahan School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3771 4664
Email
n.ajoodanian@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayegh hagh joy gavanmard
Street address
Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3771 4664
Email
n.ajoodanian@nm.mui.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
The Skull of the Adudians
Position
Clinical Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3771 4664
Email
n.ajoodanian@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
The Najmeh ajoodanian
Position
Clinical Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3771 4664
Email
n.ajoodanian@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
The Najam of the Adudians
Position
Clinical Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8176673465
Phone
+98 31 3771 4664
Email
n.ajoodanian@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
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
Title and more details about the data/document
Breastfeeding success checklist is shareable after coding.
When the data will become available and for how long
Starting data access period 6 months after printing
To whom data/document is available
The data is accessible to staff at academic institutions
Under which criteria data/document could be used
In order to eliminate ambiguities in choosing the right program
From where data/document is obtainable
Anyone can access the documentation at this email n.ajoodanian@mui.ac.ir
What processes are involved for a request to access data/document
Documents will be sent within two months after the request is received by email and review of the request.