Comparison of the effect of two different approaches to intravenous nutrition(TPN) on the pattern of weight gain in preterm infants weighing less than 1500 g admitted to the neonatal intensive care unit(NICU) of Hajar Hospital in Shahrekord
Determining and comparing the effect of two different approaches to intravenous nutrition on the pattern of weight gain in preterm newborns weighing less than 1500g admitted to the neonatal intensive care unit of Hajar hospital in Sharekord.
Design
A controlled clinical trial with parallel groups, randomized, on 60 infants.
Random Number Generator software is used for randomization.
Settings and conduct
Eligible neonates admitted to Hajar hospital neonatal intensive care unit are randomly assigned to the control group (with complete onset of intravenous feeding (TPN)) and the intervention group (with gradual onset of TPN) and their growth parameters include weight, height and head circumference up to the end of TPN and in the fortieth week of gestation (fertilization) are compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infants weighing less than 1500g.
Criteria for not entering:
Major congenital anomalies;
Syndromic features;
Severe congenital disease;
Gestational age more than 37 weeks;
Weight more than 1500 grams;
Age more than 3 days.
Intervention groups
Control group: Amino acid is prescribed at the rate of 3.5 g / kg and lipid is prescribed at the rate of 3 g / kg daily from the first day.
Intervention group: Amino acid starts at 1 g / kg on the first day, increases 1 g / kg daily to reach a maximum of 3.5 g / kg per day, and lipid starts at 0.5 g / kg per day and increases1 g / kg daily to reach a maximum of 3.5 g / kg per day.
Main outcome variables
Status of growth indicators including weight, height and head circumference
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210207050284N1
Registration date:2021-02-26, 1399/12/08
Registration timing:prospective
Last update:2021-02-26, 1399/12/08
Update count:0
Registration date
2021-02-26, 1399/12/08
Registrant information
Name
Ali Maleki Boroujeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3424 7182
Email address
www.ali.maleki.one@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two different approaches to intravenous nutrition(TPN) on the pattern of weight gain in preterm infants weighing less than 1500 g admitted to the neonatal intensive care unit(NICU) of Hajar Hospital in Shahrekord
Public title
The effect of intravenous nutrition on weight gain pattern in premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature neonate less than 1500 g
Exclusion criteria:
Congenital anomaly
Syndromic features
Age over three days
Severe illness
Gestational age more than 37 weeks
Weight more than 1500 grams
Age
From 1 day old to 3 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using Random Number Generator software, a random list of numbers from one to sixty is created.
The first thirty numbers belong to the control group and the next thirty numbers belong to the case group.
According to the order of hospitalization, infants are numbered from one to sixty and are placed in the control or intervention group based on the number.
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 Shahrekord University of Medical Sciences
Street address
Kashani Street,Vice Chancellor for Research, Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.SKUMS.REC.1399.097
Health conditions studied
1
Description of health condition studied
Premature newborn
ICD-10 code
P07.30
ICD-10 code description
Preterm newborn, unspecified weeks of gestation
Primary outcomes
1
Description
Weight
Timepoint
Daily and 40th weeks of gestational age
Method of measurement
Scales
2
Description
Height
Timepoint
Weekly and 40th weeks of gestational age
Method of measurement
Meters
3
Description
Head circumference
Timepoint
Weekly and 40th weeks of gestational age
Method of measurement
Meters
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Dextrose starts with infusion rate of 6 mg / kg / min on the first day of life and its dose is adjusted to provide random blood sugar between 60 and 120 mg / dL. Lipid ( Smoflipid emulsion20%, manufactured by Fresenius Kabi Austria Gmbh, contains soybean oil, medium chain fatty acid, omega 6 rich fish oil, olive oil and fat-soluble vitamins) at a rate of 3 g / kg and amino acid ( aminoven infant solution 10% production of Fresenius Kabi Austria Gmbh containing amino acid) starts at the rate of 5.3 g / kg. Enteral feeding starts at the first opportunity from 10 to 20 ml / kg per day depending on the infant's tolerance and when intral feeding reaches 100 ml / kg per day, intravenous feeding is stopped.
Category
Treatment - Drugs
2
Description
Intervention group: Dextrose begins at an infusion rate of 6 mg / kg / min on the first day of life and is adjusted to randomly adjust blood sugar levels between 60 and 120 mg / dL. Amino acids (10% neonatal amino solution produced by Fresenius Kabi Austria Gmbh containing amino acids) from 1 g / kg per day and lipids (20% Smoflipid emulsion, produced by Fresenius Kabi Austria Gmbh, containing soybean oil, medium chain fatty acid, rich fish oil From omega-6, olive oil and fat-soluble vitamins) start at 0.5 g / kg / day and increase by 1 g / kg both daily to a maximum of 5.3 g / kg / day for amino acids. And reach 3 grams per kilogram per day for lipids. Enteral feeding starts at the first opportunity from 10 to 20 ml / kg per day depending on the infant's tolerance and when intral feeding reaches 100 ml / kg per day, intravenous feeding is stopped.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal intensive care unit of Hajar Hospital in Shahrekord
Full name of responsible person
Roya Choopani
Street address
Kashani Blvd., Headquarters of Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
dr.choopani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Shahrekord University of Medical Sciences Headquarters،Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
vcrt@skums.ac.ir
Grant name
Grant code / Reference number
3314
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani Blvd., Headquarters of Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
dr.choopani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani Blvd., Headquarters of Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
dr.choopani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani Blvd., Headquarters of Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
dr.choopani@yahoo.com
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