Comparison of short-term consequences of calcium bolus administration with continuous infusion in intravenous feeding of preterm infants
Design
In this Clinical Trial, 90 patients will be enrolled and randomly divided into two parallel 45-patient-group.
Settings and conduct
This study will be performed on premature infants with gestational age less than 32 weeks or birth weight less than 1500 grams who are hospitalized in the intensive care unit of Al-Zahra Hospital in Tabriz and undergo total parenteral nutrition (TPN). For this purpose, patients will be examined in 2021. Two methods of intravenous calcium administration will be examined and compared. Serum alkaline phosphatase, 25 (OH) D3, and serum PTH will also be measured in the first week and one month or when TPN is stopped. These tests will be repeated for all patients at 45 days of age and will be evaluated for premature neonatal osteopenia.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all premature infants under 32 weeks or less weighing 1500 g are fed intravenously through the central vein.
Exclusion criteria: severe asphyxia; chromosomal abnormalities or congenital metabolic disorders; maternal history of hyperparathyroidism or vitamin D disorders
Intervention groups
In the first group, calcium will be administered as a solution of calcium gluconate through intravenous bolus intravenously. In the second group, calcium gluconate will be mixed in intravenous feeding serum and will be administered as a 24-hour infusion. In the group treated with 24-hour infusion, 10% calcium gluconate solution at a dose of 4-5 mL/kg/day will be added to intravenous feeding serum.
Main outcome variables
Blood levels of alkaline phosphatase; calcium; PTH, and vitamin D
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210913052466N1
Registration date:2022-01-02, 1400/10/12
Registration timing:registered_while_recruiting
Last update:2022-01-02, 1400/10/12
Update count:0
Registration date
2022-01-02, 1400/10/12
Registrant information
Name
Asmar Amirasalanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3331 0768
Email address
dr.asmar.amirarsalanzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-08, 1400/06/17
Expected recruitment end date
2022-09-08, 1401/06/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of short-term consequences of calcium bolus administration with continuous infusion in intravenous feeding of preterm infants
Public title
Comparison of short-term consequences of calcium bolus administration with continuous infusion in intravenous feeding of preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All premature infants under 32 weeks or less of 1,500 gr who are fed intravenously through the central vein.
Exclusion criteria:
Severe asphyxia
Chromosomal abnormalities or congenital metabolic disorders
Maternal history of hyperparathyroidism or vitamin D disorders
Age
To 1 month old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to intervention and control groups based on permissive block design. First, a single-digit random number will be generated if the chosen number is 0 to 4 AB permutation will be used and if it is between 5 and 9 BA permutation will be used. This method will be employed to complete the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who enter the study and assessing physicians and also statistical analyzers have no information about the grouping of infants admitted to the NICU.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Third Floor, Central Building of Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2021-08-29, 1400/06/07
Ethics committee reference number
IR.TBZMED.REC.1400.501
Health conditions studied
1
Description of health condition studied
Premature infants
ICD-10 code
E83.9
ICD-10 code description
Disorder of mineral metabolism, unspecified
Primary outcomes
1
Description
Prematurity osteopenia
Timepoint
First week and 4 to 6 weeks after bith
Method of measurement
Calcium, P, ALP will be done by spectrophotometric method with autoanalyzer and vitamin D level will be checked by ELISA method and finally the level of PTH will be measured by quantitative luminescence method with automatic Immulight.
Secondary outcomes
1
Description
Side effects of intravenous calcium injection: bradycardia, arrhythmia, seizures, skin necrosis, subcutaneous calcium
Timepoint
All side effects are evaluated instantly by the medical staff
Method of measurement
Observation
Intervention groups
1
Description
Intravenous administration of 10% calcium gluconate with a dose of 1 mg/kg of body weight for 3 to 4 times daily from second day of birth till 34 week post menstrual age to intervention group
Category
Treatment - Drugs
2
Description
24-hour infusion, 10% solution of calcium gluconate with a dose of 4-5 mL/kg /day into intravenous feeding serum from second day of birth till 34 week post menstrual age to intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Hospital of Tabriz
Full name of responsible person
Asmar Amir Arsalan Zadeh
Street address
East Azerbaijan Province, Tabriz, Shishgelan St, Children's HospitalC
City
Tabriz
Province
East Azarbaijan
Postal code
515791655
Phone
+98 41 3526 2250
Email
amiraslanzadeh.a@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7582
Email
parvizshahabi@gmail.com
Web page address
https://researchvice.tbzmed.ac.ir/
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
Assisstant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Tabriz University Main Street 3rd Floor, Central Building، Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7582
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
Assisstant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Second floor, Central Building, Golgasht St, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7582
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
Assisstant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Second floor, Central Building, Golgasht St, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7582
Email
m.mahallei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD