Protocol summary

Summary
The aim of this study was to compare the joints and nest on stress and weight gain and Finnegan score addicted baby with mother.A total of 30 eligible infants: infants 32 weeks and more addicted mothers who are not intubated and major malformations Ndashtndv in hospital neonatal intensive care unit of Ghaem and Imam Reza & Hashemi Nejad had Mshhdbstry will be selected.Before the start of the study will Shd.nvzadan written consent of mothers randomly in groups or nests will Grft.mtalh swaddling baby clothing will be replaced at intervals. Children from 8 am to 8 pm 8 pm to 8 am Shvdvaz put the butt u-shaped nest is placed. Every morning before feeding baby weight, measured with scales Seca. Weight per day up to seven days and recorded.Finnegan evaluation 24 hours after admission for two to four hours and then carried out. If up to 48 hours, the score remained less than eight, every eight hours for five to seven days of evaluation continues. Agrnmrh more than 8, the number of scoring every two hours (up to 24 hours after the last score 8) increases. Stress from observation sheet used to evaluate the collected data analysis is performed using spss software version 16.

General information

Acronym
The comparison of swaddling and nesting position in neonate abstinence syndrom in weight gain
IRCT registration information
IRCT registration number: IRCT2016062028553N1
Registration date: 2017-11-12, 1396/08/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-12, 1396/08/21
Registrant information
Name
zohre araghi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
araghiz931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical science
Expected recruitment start date
2016-05-07, 1395/02/18
Expected recruitment end date
2017-05-08, 1396/02/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of swaddling and nesting position in neonate abstinence syndrom in weight gain , stress and finnegan score
Public title
The comparison of swaddling and nesting position in neonate abstinence syndrom in weight gain , stress and finnegan score
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age of 32 weeks and more, the need for mechanical ventilation, such as the lack of major malformations (MMC and meningomyelocele), absence of severe cardiovascular disorders .myarhay outputs are: personal fulfillment parents to discharge the baby, the baby died , infants who have severe cardiovascular disorders. Babies with sepsis and metabolic disorders, sedative and hypnotic drugs to infants requiring phototherapy are Gyrnd.nvzadany
Age
From 8 months old to 10 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Babies with addicted mothers are selected by simple random assignment. One in one They fall into one of the two groups of sandals and nests.

Secondary Ids

1

Registry name
مرکز ثبت کارآزمایی بالینی ایران
Secondary trial Id
28553
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
University Street
City
mashhad
Postal code
13944-91388
Approval date
2016-05-07, 1395/02/18
Ethics committee reference number
941357

Health conditions studied

1

Description of health condition studied
Weight gain and stress and Fingen baby with addicted mother
ICD-10 code
p96.1
ICD-10 code description
Drug withdrawal syndrome in infant of dependent motherNeonatal abstinence syndrome

Primary outcomes

1

Description
Weighing
Timepoint
Seven days
Method of measurement
Weight with weight

Secondary outcomes

1

Description
Stress
Timepoint
Seven days
Method of measurement
Observation sheet tool

2

Description
finnegan
Timepoint
5 to 7 days
Method of measurement
finnegan form

Intervention groups

1

Description
Category
Other

2

Description
Addicted maternal newborns are selected by simple random assignment. As one in between They fall into one of the two groups of buttocks or nests. In the nest group, the neonate is placed in the yoke in the first day.The second three days are placed inside the gondolas.The baby is weighed up to 7 days a day. The stress of a baby is measured up to 7 days.The baby's deprivation according to the Finagan form and according to the score obtained from 5 days to 7 days for the infant is completed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
zohre araghi
Street address
Faculty of Nursing and Midwifery of Mashhad
City
mashhad

2

Recruitment center
Name of recruitment center
Imam Reza Hospital (AS)
Full name of responsible person
zohre araghi
Street address
Ibn Sina Street / Imam Reza Square
City
mashhad

3

Recruitment center
Name of recruitment center
Hashemi Nejad Hospital
Full name of responsible person
zohre araghi
Street address
Shahid Hasheminejad Street
City
mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research of Mashhad University of Medical Sciences
Full name of responsible person
Tayyib Reyhani
Street address
School of Nursing and Midwifery
City
Mashhad
Grant name
Grant code / Reference number
941357
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Mashhad 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
Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences
Full name of responsible person
zohre araghi
Position
Masters of Neonatal Care
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
Mashhad
Postal code
13944-91388
Phone
+98 51 3859 1511
Fax
Email
araghiz931@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam Reza Hospital (AS)
Full name of responsible person
Dr. Ashraf Mohammadzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Ibn Sina Street / Imam Reza Square
City
Mashhad
Postal code
9137913316
Phone
+98 51385430319
Fax
05138591057/38525000
Email
A_mohammadzade@mums.ac.irIRH@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
araghi zohre
Position
Masters of Neonatal Care
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 38597313
Email
araghiz931@mums.ac.irnms.it[at]mums.ac.ir
Web page address
http://nurse.mums.ac.ir

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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