The effect of nursing care training package after gastrointestinal disorders surgery on length of hospital stay-neonatal weight gain
Design
Clinical trial has a control group with an intervention group, one-blind, non-randomized, on 60 patients
Settings and conduct
The present study will be performed on 30 infants in each group (control and intervention) in the neonatal intensive care unit of Akbar Hospital in Mashhad. This study will be done in two stages. In the first stage, the post-surgery care package for gastrointestinal abnormalities will be assembled based on a review of valid texts and under the supervision of experts. In the second stage, after obtaining permission from the university ethics committee, sampling of the control and intervention group will be done. During this phase, in addition to collecting clinical data, infants are monitored for weight gain and length of hospital stay. Individuals under study and analyst will be unaware of the intervention and control groups.
Participants/Inclusion and exclusion criteria
Informed consent of the parents, the infant with congenital gastrointestinal abnormalities (including esophageal atresia, intestinal atresia, closed anus of the infant) to the approval of the treating physician, the infant weighs more than 1500 grams at birth. The baby is 37 weeks old
Intervention groups
Intervention: Infants with congenital gastrointestinal disorders undergo reconstructive surgery, whose postoperative care will be based on a care package.
Control: Infants with congenital gastrointestinal abnormalities undergo reconstructive surgery whose postoperative care is routinely performed.
Main outcome variables
-Duration of hospitalization from the time of admission until discharge
-Weight gain baby
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201222049793N1
Registration date:2021-08-14, 1400/05/23
Registration timing:registered_while_recruiting
Last update:2021-08-14, 1400/05/23
Update count:0
Registration date
2021-08-14, 1400/05/23
Registrant information
Name
Maryam Tavakolypolgerd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3678 7678
Email address
tavakolypm1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-25, 1400/03/04
Expected recruitment end date
2021-09-26, 1400/07/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing care training package on the duration of hospitalization and neonatal weight gain after surgery for gastrointestinal disorders
Public title
Evaluation of the effects of nursing care training package on the duration of hospitalization and neonatal weight gain after surgery for gastrointestinal disorders in neonatal intensive care unit.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
conscious parental consent
Infant with congenital gastrointestinal abnormalities (including esophageal atresia, intestinal atresia, closed anus of the operated infant) in the hospital
The baby weighs more than 1500 grams at birth.
infant 37 weeks later
Exclusion criteria:
Occurrence of kidney-liver disease at the same time that makes it difficult to estimate the patient's weight.
Permanent transfer from hospital before discharge
Discharge from the hospital with personal consent before completing treatment
Age
From 8 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants (infants) in this study were blind.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
PhD Crossroads - School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9491395512
Approval date
2020-07-24, 1399/05/03
Ethics committee reference number
Ir.mums.nurse.rec.1399.026
Health conditions studied
1
Description of health condition studied
Imperforated Anus
ICD-10 code
K62.89
ICD-10 code description
Other specified diseases of anus
2
Description of health condition studied
Duodenal Atresia
ICD-10 code
K31.89
ICD-10 code description
Other diseases of duodenum
3
Description of health condition studied
Esophageal atresia
ICD-10 code
K22
ICD-10 code description
Other diseases of esophagus
Primary outcomes
1
Description
Comparison of the effect of nursing care training package on length of hospital stay and neonatal weight gain after gastrointestinal malignancy surgery
Timepoint
Measurement of hospitalization duration and neonatal weight gain after surgery until discharge in control and intervention groups
Method of measurement
Neonatal records and demographic information
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infants with gastrointestinal abnormalities who have undergone reconstructive surgery and postoperative care based on a care package (in the field of surgical site care, respiratory care, and patient-related connections, nutritional care, correct positions and principles of position change, infection control, Blood care, excretory care) will be performed.
Category
Other
2
Description
Control group: : Infants with congenital gastrointestinal disorders undergo reconstructive surgery whose postoperative care will be routine.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان اکبر
Full name of responsible person
Rezaeian Aramesh
Street address
PhD Crossroads - School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9491395512
Phone
+98 51 3856 1843
Email
rezaeianA@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Robabeh latif nejad
Street address
Doctora Crossroads - School of Nursing and Midwifery
City
mashhad
Province
Razavi Khorasan
Postal code
9491395512
Phone
+98 51 3859 1512
Fax
+98 51 3859 1512
Email
latifnejadr@mums.ac.ir
Web page address
https://www.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Tavakoly Polgerd Maryam
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bolvar Razi 13
City
Darghaz
Province
Razavi Khorasan
Postal code
9491395512
Phone
+98 51 3859 1511
Email
tavakolypm1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
rezaeian aramesh
Position
هیئت علمی
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Doctora Crossroads - School of Nursing and Midwifery
City
mashhad
Province
Razavi Khorasan
Postal code
9491395512
Phone
+98 51 3859 1512
Fax
+98 51 3859 1512
Email
rezaeiana@mums.ac.ir
Web page address
https://www.mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
مریم توکلی پلگرد
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Doctora Crossroads - School of Nursing and Midwifery
City
mashhad
Province
Razavi Khorasan
Postal code
9491395512
Phone
+98 51 3859 1512
Email
tavakolypm1@mums.ac.ir
Web page address
https://www.mums.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