Investigating the effect of trophic nutrition on the length of hospitalization and weight of low birth weight infants at discharge time in the Neonatal Intensive Care Unit.
Determining the effect of trophic nutrition on the duration of hospitalization and the weight at the time of discharge of low birth weight infants in the neonatal intensive care unit
Design
Clinical trial, with control and test group, without blinding, randomized by block method
Settings and conduct
It is an experimental interventional study with a block randomization method in the neonatal intensive care unit of Shahid Sadoughi Hospital, Yazd.
Participants/Inclusion and exclusion criteria
Entry requirements:
Nonates weighing 1000-2000 grams at birth
Fetal age 26 weeks to 36 weeks and 6 days (based on the first day of the mother's last period and early pregnancy ultrasound)
Non-entry conditions:
Neonates with major congenital anomalies
Neonates with severe asphyxia
Infants referred from other hospitals
Infants with cardiac and metabolic disease
Intervention groups
Intervention group: low birth weight Neonates for whom trophic nutrition is started in the first 72 hours after birth along with intravenous nutrition (by a specialist doctor).
Main outcome variables
The length of hospitalization of low birth weight neonates - Discharge weight of low birth weight neonates
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231016059743N1
Registration date:2023-11-27, 1402/09/06
Registration timing:prospective
Last update:2023-11-27, 1402/09/06
Update count:0
Registration date
2023-11-27, 1402/09/06
Registrant information
Name
Abolfazl Azarmi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3366 5225
Email address
a.azarmi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of trophic nutrition on the length of hospitalization and weight of low birth weight infants at discharge time in the Neonatal Intensive Care Unit.
Public title
Investigating the effect of trophic nutrition on the length of hospitalization and weight of low birth weight infants at discharge time.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates weighing 1000-2000 grams at birth
Fetal age 26 weeks to 36 weeks and 6 days (based on the first day of the mother's last period and early pregnancy ultrasound)
Exclusion criteria:
Neonates with major congenital anomalies
Neonates with severe asphyxia
Neonates referred from other hospitals
Neonates with cardiac and metabolic disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 infants eligible for the study will be placed in two groups of 30 people. In order to randomly assign and ensure the balance of the number of people in the groups, the block randomization method will be used. In this study, blocks of four are used, where half of the people in each block are placed in one group and the other half in another group.
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 Yazd University of Medical Sciences
Street address
شهر یزد،صفائیه،خیابان بوعلی،پژوهشکده علوم تولیدمثل یزد
Duration of hospitalization in low birth weight infants-discharge weight in low birth weight infants
Timepoint
From the time of admission to the discharge of low birth weight babies in the neonatal intensive care unit
Method of measurement
In order to measure the baby's weight at the time of discharge, we will use the scale available in the neonatal intensive care unit, which is of the zyklusmed brand (made in Iran under a German license). In order to determine the accuracy of the weight, its standard of accuracy will be checked by a 1 kg weight. In order to determine the reliability of the weight, it has been done through independent and repeated measurements, in other words, the researcher has weighed a patient several times with the same weight, and if the resulting numbers are equal, it is the reason that the weight has the necessary reliability.
Secondary outcomes
1
Description
Frequency of neonatal sepsis in low birth weight babies - Frequency of necrotizing enterocolitis in low birth weight neonates- Frequency of premature osteopenia in low birth weight neonates
Timepoint
From the time of admission to the discharge of low birth weight babies in the neonatal intensive care unit
Method of measurement
The criterion of sepsis is a positive blood culture by the BACTEC method (a product of America, Becton Dickinson company) when 3 cc of blood is taken from the neonate and sent to the laboratory of Shahid Sadoughi Hospital in Yazd, necrotizing enterocolitis is also based on Clinical criteria (abdominal distension, apnea, milk intolerance and residue) and paraclinical criteria (abdominal imaging) are defined. Prematurity osteopenia is also based on phosphorus index less than 4 and alkaline phosphatase more than 900 at 28 days of birth. which is determined during a blood test taken from the baby.
Intervention groups
1
Description
Intervention group: low birth weight babies who receive trophic nutrition along with routine intravenous feeding in the neonatal intensive care unit.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd city
Full name of responsible person
Dr. Seyed Reza Mirjalili
Street address
Yazd City - Shahid Qandi Blvd. - Ibn Sina Blvd
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
sadoghi-hospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Seyed Reza Mirjalili
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Seyed Reza Mirjalili
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Palestine Blvd., Lale St., Yasman Alley, 8
City
Yazd
Province
Yazd
Postal code
8915167367
Phone
+98 35 3830 1039
Email
dr_sr_mirjalili@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Seyed Reza Mirjalili
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Palestine Boulevard-Laleh Alley-Yasman Alley 8
City
Yazd
Province
Yazd
Postal code
8915167367
Phone
+98 35 3830 1039
Email
dr_sr_mirjalili@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Abolfazl Azarmi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Eastern Madani St., in front of Ardibehesht Kindergarten, No. 133
City
Khomeini shahr
Province
Isfehan
Postal code
8415665511
Phone
+98 31 3366 5225
Email
A.azarmi@stu.ssu.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