Protocol summary

Study aim
Considering the importance of prematurity and weight gain in long-term health outcomes, lack of an agreement on parenteral nutrition diets for Very Low Birth Weight (VLBW) neonates, and role of glucose in nutrition, this study investigates the effect of increasing calories by adding glucose intake on weight gain in premature neonates.
Design
A parallel-group, blinded, phase 3 clinical trial design of 82 patients who were divided into intervention and control groups sequentially.
Settings and conduct
The clinical trial will be conducted on VLBW neonates in Neonatal Intensive Care Unit (NICU) of Ali Asghar, Akbar Abadi, and FiroozAbadi from May to December 2020. All the neonates will receive Total Parenteral Nutrition (TPN). While neonates in the intervention group will intake 12.5% DW, those in the control group will intake 10% DW. Birth weight and neonate's weight in the fifth, seventh, tenth, and fifteenth days after birth will be recorded by a specific scale. We consider the length of hospitalization and the date on which the neonate will be released. The daily calories intaken will be calculated based on TPN, serum volume (until neonate meet 150cc/kg), and breastfeed (if applies). The procedure will be continued until samples reach their birth weights, the duration that is used as the primary criterion for efficacy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: one-to-thirty-day neonates with birth weights lower than 1500g Exclusion criteria: Septic neonates, due to probable undesired interventions
Intervention groups
Neonates, who meet inclusion criteria, receive Total Parenteral Nutrition (TPN) and will intake 10% and 12.5% dextrose water (DW) serum. Then, we compare the weight gaining of neonates intaken 12.5% DW with those intaken 10% DW.
Main outcome variables
Birth weight; Days receiving TPN; Steroid before birth; Surfactant, Daily weight; Invasive ventilation duration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200617047807N1
Registration date: 2020-07-05, 1399/04/15
Registration timing: registered_while_recruiting

Last update: 2020-07-05, 1399/04/15
Update count: 0
Registration date
2020-07-05, 1399/04/15
Registrant information
Name
Farnaz Firuzian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 0796
Email address
firouzian.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of weight gaining of Very Low Birth Weight (VLBW) neonates who intake 10% and 12.5% dextrose serum in NICU wards of Ali Asghar and Akbar Abadi hospitals from May to December, 2020
Public title
Comparison of weight gaining of premature neonates intaking 10% and 12.5% dextrose serum
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Birth weights under 1500 gr
Exclusion criteria:
Septic neonates
Age
From 1 day old to 1 month old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Before sample inclusion, parents are provided with a detailed description of the clinical trial and are informed about dextrose serum dose. Considering the fact that samples of the trial are neonates, they have no understanding of the dosage and hence are blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Commitee of School of Medicine- Iran University of Medical Sciences
Street address
Hemat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-09-17, 1398/06/26
Ethics committee reference number
IR.IUMS.FMD.REC.1398.201

Health conditions studied

1

Description of health condition studied
Weight gain in premature neonates with birth wight lower than 1500g
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Weight of neonate
Timepoint
Fifth, seventh, tenth, and fifteenth days after birth
Method of measurement
Standard scale

Secondary outcomes

1

Description
Duration of reaching the birth weight
Timepoint
Daily
Method of measurement
Registry

Intervention groups

1

Description
24-hour infusion of 12.5% dextrose serum (produced by Iran Injectable and Pharmaceutical Products Company (IPPC)) which is started from 70cc/kg and gradually increase to 150cc/kg until fifth day after birth
Category
Treatment - Drugs

2

Description
24-hour infusion of 10% dextrose serum (produced by Iran Injectable and Pharmaceutical Products Company (IPPC)) which is started from 70cc/kg and gradually increased to 150cc/kg until the fifth day after birth
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Farnaz Firoozian
Street address
Dastgerdi
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2222 2041
Email
aach@iums.ac.ir
Web page address
https://crtha.iums.ac.ir/fa?sid=46

2

Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Farnaz Firoozian
Street address
Molavi
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Web page address
https://crta.iums.ac.ir/

3

Recruitment center
Name of recruitment center
FiroozAbadi Hospital
Full name of responsible person
Farnaz Firoozian
Street address
Fadaian Eslam
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 5104 8000
Email
hospfa@iums.ac.ir
Web page address
https://hospfa.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4704
Email
amotevalian@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farnaz Firoozian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985859399
Phone
+98 21 2242 0796
Email
farnaz.firoozian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farhad Abolhassan Choobdar
Position
Assisstant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dastgerdi
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2222 2041
Email
choobdar.f@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnaz Firoozian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985859399
Phone
+98 21 2242 0796
Email
farnaz.firoozian@gmail.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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