Protocol summary

Summary
Term and near-term Babies (> 35 week) or (> 2500 g) with serum bilirubin levels in the therapeutic range (> 15 mg / dl) who admitted in bentolhoda hospital, Bojnord,Iran without signs of hemolysis, internal bleeding, G6PD sepsis, severe respiratory illness requiring mechanical ventilation and congenital anomalies are enrolled after parental consent. Since the Babies are eligible to enter the total number of samples is 60. Methods: in this case- control trial all babies enrolled in the study after routine tests, including blood group of baby and mother, G6PD, bil (t, d), coombs, Pbs, Hb, Hct, Retic were collected. Phenobarbital with dose (12 mg / kg) administered orally in one dose, randomly to half of babies in addition with phototherapy. Serum bil (T, D) after 24 and 72 hours was evaluated within all babies. Indication of starting and discontinuing phototherapy was planned as AAP guidelines (starting at bil>15mg/dl, discontinuing at 50-70% of bil T). Phototherapy duration also will be compared between case and control groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014102919716N4
Registration date: 2015-03-15, 1393/12/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-03-15, 1393/12/24
Registrant information
Name
Ghasem Bayani
Name of organization / entity
North Khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 4221 1008
Email address
bayani.ghasem@yahoo.com
Recruitment status
Recruitment complete
Funding source
North Khorasan University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of single dose Phenobarbital on treatment of term and near term newborn'shyper bilirubinemia admitted in the hospital
Public title
Effect of single dose Phenobarbital on treatment of term and near term newborn'shyper bilirubinemia admitted in the hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Term and near-term babies (> 35 week) or (> 2500 g) with serum bilirubin levels in the therapeutic range (> 15 mg / dl) who admitted in hospital without signs of hemolysis, internal bleeding, G6PD, sepsis, severe respiratory illness requiring mechanical ventilation and congenital anomalies are enrolled after parental consent.
Age
From 1 day old to 7 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
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
North Khorasan University of Medical Sciences
Street address
North Khorasan University of Medical Sciences, Berenji alley, Bojnord, North Khorasan
City
Bojnord
Postal code
2247124
Approval date
2014-10-18, 1393/07/26
Ethics committee reference number
756-پ-93

Health conditions studied

1

Description of health condition studied
Near term newborn's hyper bilirubinemia
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified

Primary outcomes

1

Description
Serum bilirubin
Timepoint
Weeks 35-42
Method of measurement
Blood sample test

2

Description
Hematocrit,coombs,blood group,retic count
Timepoint
at birth time and starting treatment to discharge at hospital
Method of measurement
serum examination

Secondary outcomes

1

Description
Hospitalization period, phototherapy duration
Timepoint
Days of hospitalization, hours of phototherapy
Method of measurement
Medical records

Intervention groups

1

Description
In the intervention group babies receive phenobarbital with phototherapy. Phenobarbital with dose (12 mg / kg) administered orally in one dose. Indication of starting and discontinuing phototherapy was planned as AAP guidelines (starting at bil>15mg/dl, discontinuing at 50-70% of bil T).
Category
Treatment - Drugs

2

Description
Control group give only phototherapy,without phenobarbital
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Bentolhoda
Full name of responsible person
Ghasem Bayani
Street address
Zayeshgah st., Bojnord, North Khorasan
City
Bojnord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Dr. Alireza Golshan
Street address
North Khorasan University of Medical Sciences, Berenji alley, Bojnord, North Khorasan
City
Bojnord
Grant name
1 درصد
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
North Khorasan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Dr. Ghasem Bayani
Position
MD, pediatrician
Other areas of specialty/work
Street address
North Khorasan University of Medical Sciences, Berenji alley, Bojnord, North Khorasan
City
Bojnord
Postal code
9445445
Phone
+98 58 4221 1008
Fax
+98 58 4224 7124
Email
bayani.ghasem@yahoo.com
Web page address
http://nkums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Dr. Ghasem Bayani
Position
MD, pediatrician
Other areas of specialty/work
Street address
North Khorasan University of Medical Sciences, Berenji alley, Bojnord, North Khorasan
City
Bojnord
Postal code
9445445
Phone
+98 58 4221 1008
Fax
+98 58 4224 7124
Email
bayani.ghasem@yahoo.com
Web page address
nkums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Dr. Ghasem Bayani
Position
MD, pediatrician
Other areas of specialty/work
Street address
North Khorasan University of Medical Sciences, Berenji alley, Bojnord, North Khorasan
City
Bojnord
Postal code
2247124
Phone
+98 58 4221 1008
Fax
+98 58 4224 7124
Email
bayani.ghasem@yahoo.com
Web page address
nkums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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