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The evaluation of Melatonin effect on short outcome in newborns with hypoxic ischemic encephalopathy

Protocol summary

Study aim
The evaluation of Melatonin effect on short outcome in newborns with hypoxic ischemic encephalopathy
Design
This is a clinical trial, phase II, in which 66 eligible patients will be assigned to the intervention and control groups
Settings and conduct
The eligible newborns with hypoxic- ischemic- encephalopathy referring to the Fatemieh Hospital in Hamadan city during the study period will be enrolled .
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least one of the diagnostic criteria of HIE include: APGAR score <5 at 5 minutes, Fetal heart rate <60 bpm, Prolonged metabolic acidosis(>1 hour), Need of positive pressure ventilation>1 min or delay in crying >10 min of birth, Occurrence of acute perinatal events, Seizures occur in the first 24 to 48 hours after birth. Exclusion criteria: Gestational age <36weeks, Congenital anomalies, Unperforated anus, Intracranial hemorrhage
Intervention groups
Intervention group: Routine treatment plus intravenous injection of melatonin 1O mg/kg day on the first, second and third days and then every other day on the fifth, seventh, and ninth days to a maximum of 6 doses, Control group: Just routine treatment
Main outcome variables
Primary outcome: Seizure attacks, time of onset of consciousness, the occurrence of death, duration of hospitalization, time to start oral nutrition Secondary outcome: Drug complications such as thrombocytopenia.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160523028008N19
Registration date: 2021-12-06, 1400/09/15
Registration timing: prospective

Last update: 2021-12-06, 1400/09/15
Update count: 0
Registration date
2021-12-06, 1400/09/15
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-21, 1400/09/30
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of Melatonin effect on short outcome in newborns with hypoxic ischemic encephalopathy
Public title
evaluation of Melatonin effect on short outcome in newborns with hypoxic ischemic encephalopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least one of diagnostic criteria of HIE include: 1-APGAR score <5 at 5 minutes Fetal heart rate <60 bpm Prolonged metabolic acidosis(>1 hour) Need of positive pressure ventilation>1 min or delay in crying >10 min of birth Occurrence of acute perinatal events Exclusion criteria Seizures occur in the first 24 to 48 hours after birth
Exclusion criteria:
Gestational age <36weeks Congenital anomalies Unperforated anus Intracranial hemorrhage
Age
From 1 day old to 28 days old
Gender
Both
Phase
2-3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The person analyzing the results is not aware of patient allocation, so the study is single-blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-09-04, 1400/06/13
Ethics committee reference number
IR.UMSHA.REC.1400.452

Health conditions studied

1

Description of health condition studied
Hypoxic ischemic encephalopathy [HIE]
ICD-10 code
P91.6
ICD-10 code description
Hypoxic ischemic encephalopathy [HIE]

Primary outcomes

1

Description
Seizure attacks
Timepoint
From the beginning of the intervention until two weeks thereafter
Method of measurement
With clinical examination

2

Description
Time of onset of consciousness
Timepoint
From the beginning of the intervention until two weeks thereafter
Method of measurement
With clinical examination

3

Description
Occurrence of death
Timepoint
From the beginning of the intervention until two weeks thereafter
Method of measurement
With clinical examination

4

Description
Duration of hospitalization
Timepoint
From the beginning of the intervention until two weeks thereafter
Method of measurement
Based on the medical document

5

Description
Drug complications such as induced topical hypothermia, bradycardia and subcutaneous necrosis
Timepoint
From the beginning of the intervention until two weeks thereafter
Method of measurement
With clinical examination

6

Description
Time to start oral nutrition
Timepoint
From the beginning of the intervention until two weeks thereafter
Method of measurement
By taking a history

Secondary outcomes

1

Description
Drug complications such as thrombocytopenia
Timepoint
From the beginning of the intervention up to two weeks late
Method of measurement
By laboratory tests

Intervention groups

1

Description
Intervention group: Routine treatment plus intravenous injection of melatonin 1O mg/kgday on the first, second and third days and then every other day on the fifth, seventh, and ninth days to a maximum of 6 doses
Category
Treatment - Drugs

2

Description
Control group: Just routine treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemiyeh Hospital
Full name of responsible person
Behnaz Basiri
Street address
Fatemiyeh Hospital, Kermanshah street, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 31 26779
Email
b.basiri@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Kiani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Fatemiyeh Hospital, Kermanshah street, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 917 332 4977
Email
NahidKiani65@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behnaz Basiri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Fatemiyeh Hospital, Kermanshah street, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
b.basiri@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Kiani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Fatemiyeh Hospital, Kermanshah street, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 918 812 8458
Email
NahidKiani65@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
There is not 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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