Comparison of the effect of prophylactic phototherapy with therapeutic phototherapy on serum bilirubin and neurodevelopment in 1500-2000-gr preterm neonates
Comparison of the effect of prophylactic phototherapy with therapeutic phototherapy on neurodevelopment among 1500-2000 gram preterm neonates born in Shohadaye Khalije Fars and Salman Farsi Hospitals in Bushehr in 2021-2022
Design
Clinical trial with control group, with parallel groups, single blind, randomized, on 200 patients. R software was used for randomization
Settings and conduct
Study place: Neonatal wards of Salman Farsi and Shohadaye Khalije Fars hospitals in Bushehr.
Study population: All neonates under 37 weeks old weighing 1500-2000 grams hospitalized in the mentioned places.
Blinding: One-way blinding.
How to blind: Parents do not know if their baby is in the intervention group or the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Premature infants weighing 1500-2000 gram. Non-inclusion criteria: Dissatisfaction with participating in the study, asphyxia, cerebral hemorrhage, meningitis, neurological problems such as seizures without jaundice, structural brain problems, Hypoxia, sepsis (positive blood culture), ABO incompatibility, first-day jaundice
Intervention groups
Intervention group (A): Infants receive prophylactic phototherapy in the first 24 hours of birth.
Control group (B): Infants do not receive prophylactic phototherapy in the first 24 hours of birth and receive phototherapy if bilirubin increases according to the curves in Nelson's book.
Main outcome variables
Direct bilirubin;
Total bilirubin;
Development
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211015052778N1
Registration date:2022-05-11, 1401/02/21
Registration timing:prospective
Last update:2022-05-11, 1401/02/21
Update count:0
Registration date
2022-05-11, 1401/02/21
Registrant information
Name
Soroush Ostadzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3333 5250
Email address
soorena767@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of prophylactic phototherapy with therapeutic phototherapy on serum bilirubin and neurodevelopment in 1500-2000-gr preterm neonates
Public title
Evaluation of phototherapy on premature neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants weighing 1500-2000 gr
Exclusion criteria:
Dissatisfaction with participating in the study
Asphyxia
Cerebral hemorrhage
Meningitis
Neurological problems such as seizures without jaundice
Structural brain problems
Hypoxia
Sepsis (positive blood culture)
ABO incompatibility
First-day jaundice
Age
To 4 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Infants with ≤1500-2000 gr will be randomly divided into two groups.
Random allocation was performed using R software and the resulting random design will be placed in special envelopes. Infants who meet the required criteria will be assigned to the intervention group (A) and the control group (B) consecutively. The random allocation file is attached in the appendices section. The intervening physician will not be aware of the random allocation scheme and the number of blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Study participants do not know whether they are in the control or the intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Boushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences and Health Services, In front of Mosallaye Namaze Jome, Moallem St.
City
Boushehr
Province
Boushehr
Postal code
7514633341
Approval date
2021-05-19, 1400/02/29
Ethics committee reference number
IR.BPUMS.REC.1400.024
Health conditions studied
1
Description of health condition studied
Hyperbilirubinemia
ICD-10 code
E80.6
ICD-10 code description
Other disorders of bilirubin metabolism
Primary outcomes
1
Description
Total bilirubin
Timepoint
Measurement of total blood bilirubin at the beginning of the study (before the intervention) and then on days 1, 3, 5, 7 and 10 after birth
Method of measurement
In Shohadaye Khalije Fars Hospital, the bilirubin samples will be tested based on photometric principles and using Jendrssik Grof Assay kit from Biorex Fars Company through DIRUI CS-400 Auto-Chemistry Analyzer. In Salman Farsi Hospital, the bilirubin samples will be measured based on the same principles and kit used in the Shohadaye Khalije Fars Hospital using the DIRUI CS-400 Auto-Chemistry Analyzer.
2
Description
Development
Timepoint
2 and 4 month
Method of measurement
By ASQ questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: infants will receive prophylactic phototherapy in the first 24 hours after birth. Phototherapy will be performed using a 5-DTA-lamp portable Phototherapy Equipment - XHZ-90P with Philips lamps in Shohadaye Khalije Fars Hospital and using Tucson phototherapy device with Philips lamps in Social Security Hospital (Salman Farsi Hospital)
Category
Treatment - Devices
2
Description
Control group: receive no prophylaxis, and infants will receive theraputic phototherapy after bilirubin rise according to the curves in Nelson's book.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Khalije Fars hospital
Full name of responsible person
Soroush Ostadzade
Street address
Taleghani Blvd
City
Boushehr
Province
Boushehr
Postal code
۷۵۱۷۹۳۳۷۵۵
Phone
+98 77 3345 5375
Email
mpgh@bpums.ac.ir
2
Recruitment center
Name of recruitment center
Salman Farsi hospital
Full name of responsible person
Soroush Ostadzade
Street address
Sabzabad Street
City
Boushehr
Province
Boushehr
Postal code
7518759416
Phone
+98 77 3344 2815
Email
salmanfarsi.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Hasan Sedaghat
Street address
Moalem Blvd
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
s.firoozbakht@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Soroush Ostadzade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Sina Dormitory, Hafez Ave., Taleghani Blvd
City
Boushehr
Province
Boushehr
Postal code
7514665936
Phone
+98 77 3333 5250
Fax
Email
soorena767@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Saeede Firoozbakht
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Sangi street
City
Boushehr
Province
Boushehr
Postal code
۷۵۱۷۹۳۳۷۵۵
Phone
+98 77 3345 5375
Email
s.firouzbakht@bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Saeede Firoozbakht
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Sangi street
City
Boushehr
Province
Boushehr
Postal code
۷۵۱۷۹۳۳۷۵۵
Phone
+98 77 3345 5375
Email
s.firouzbakht@bpums.ac.ir
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
Due to possible use by ourselves for future projects