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Implementation of parenteral nutrition guideline and comparison of its early outcomes with conventional parenteral nutrition in neonatal intensive care unit

Protocol summary

Study aim
The objective of this study is to assess the effects of the implementation of a standardized clinical guideline for intravenous nutrition in the Neonatal Intensive Care Unit (NICU) on growth and its related early nutritional and clinical outcomes.
Design
A phase 2 clinical trial involving a single cohort of 70 preterm neonates will be conducted for examination.
Settings and conduct
The research will be carried out in the Neonatal Intensive Care Unit of Alzahra Hospital in Tabriz, focusing on preterm neonates requiring parenteral nutrition. The parenteral nutrition solutions will be formulated in a controlled clean room environment, with the macronutrient and micronutrient compositions tailored individually for each neonate.
Participants/Inclusion and exclusion criteria
Inclusion criteria: preterm infants born before 32 weeks of gestation and/or those weighing less than 1250 g Exclusion criteria: Infants with significant congenital anomalies, chromosomal disorders, congenital metabolic conditions, cyanotic heart disease, severe asphyxia (Apgar 5 min below 4), as well as those transfer to other hospitals or who experience complications leading to premature death within the first week of life.
Intervention groups
Parenteral solutions comprising dextrose, amino acids, and lipids will be formulated in accordance with established protocols, taking into consideration the specific characteristics of neonates, such as weight, height, and age. These solutions will be utilized to provide nutritional support for neonates.
Main outcome variables
Intake of energy, carbohydrate, protein, and fat; weight, height, and head circumference; incidence of sepsis; incidence of retinopathy of prematurity; incidence of necrosis enterocolitis; incidence of intraventricular bleeding

General information

Reason for update
Acronym
PN
IRCT registration information
IRCT registration number: IRCT20240519061838N2
Registration date: 2024-11-24, 1403/09/04
Registration timing: registered_while_recruiting

Last update: 2024-11-24, 1403/09/04
Update count: 0
Registration date
2024-11-24, 1403/09/04
Registrant information
Name
Khatereh Rezazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 6182
Email address
rezazadekhatere@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Implementation of parenteral nutrition guideline and comparison of its early outcomes with conventional parenteral nutrition in neonatal intensive care unit
Public title
Implementation of parenteral nutrition guideline
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
preterm infants born before 32 weeks or weighing less than 1250 grams
Exclusion criteria:
Infants with significant congenital anomalies Infants with chromosomal disorders Infants with congenital metabolic conditions Infants with cyanotic heart disease, Infants with severe asphyxia (Apgar 5 min below 4), transfer to other hospitals premature death within the first week of life
Age
From 1 day old to 2 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The design of the study is before and after in which the status of infants will be evaluated before the implementation of the parenteral nutrition guideline and after the implementation.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht street, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.TBZMED.REC.1397.940

Health conditions studied

1

Description of health condition studied
Preterm infant
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Daily energy intake
Timepoint
During 28 days after birth
Method of measurement
Calculate the amount of energy in parenteral nutrition solutions

2

Description
Daily intake of protein
Timepoint
During 28 days after birth
Method of measurement
Calculation of daily intake of amino acid solution of neonate

3

Description
Daily intake of carbohydrate
Timepoint
During 28 days after birth
Method of measurement
Calculation of daily intake of dextrose solution of neonate

4

Description
Daily intake of fat
Timepoint
During 28 days after birth
Method of measurement
Calculation of daily intake of intralipid solution of neonate

Secondary outcomes

1

Description
sepsis
Timepoint
During 28 days after birth
Method of measurement
Blood culture and urine culture

2

Description
occurrence of retinopathy of prematurity
Timepoint
During 28 days after birth
Method of measurement
Clinical examination

3

Description
occurrence of necrotizing enterocolitis
Timepoint
During 28 days after birth
Method of measurement
X-ray and stool exam

4

Description
occurrence of intraventricular hemorrhage
Timepoint
During 28 days after birth
Method of measurement
Clinical examination and head ultrasound

Intervention groups

1

Description
Intervention group: preterm infants will receive parenteral nutrition solutions that include dextrose, amino acids, and lipids, along with vitamins and minerals tailored to the individual characteristics of each neonate. The administration of parenteral nutrition solutions will be provided over a 24-hour period via venous access assigned to each neonate.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Neonatal intensive care unit (NICU) of Alzahra Hospital in Tabriz
Full name of responsible person
Majid Mahallei
Street address
Golgasht street, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 914 310 8400
Email
m.mahallei@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Mahallei
Street address
Mardani Azar Children Hospital, Mardani Azar Street, Khavaran Town
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 914 310 8400
Email
m.mahallei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Majid Mahallei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mardani Azar Children Hospital, Mardani Azar Street, Khavaran Street
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 914 310 8400
Email
m.mahallei@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Mahallei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mardani Azar Children Hospital, Mardani Azar Street, Khavaran Street
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 914 310 8400
Email
m.mahallei@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Mahallei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mardani Azar Children Hospital, Mardani Azar Street, Khavaran Street
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 914 310 8400
Email
m.mahallei@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
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