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Study of the Effects of Perinatal Iron Deficiency and Its Treatment on Auditory Brainstem Evoked Response in Neonates at Risk of Latent Iron Deficiency in the Vali-e Asr Hospital Maternity Ward

Protocol summary

Summary
In the first phase, a prospective cohort study shall be conducted wherein maternal and cord blood samples will be taken after birth and will be sent to the laboratory for measurement of ferritin levels. Study infants will be divided into two groups, Serum Feritin≤75 and Serum Feritin>75 ng/mL. For initial assessment of nervous system development in the auditory pathway, bilateral monaural ABR shall be utilized within the first 48 hours after birth by an audiologist. The test is repeated three times and an average of the waves from two out of three of the tests is used for analysis. The ABR data is analyzed by an audiologist that is unaware of the iron levels. ABR results of the strongest ear, i.e. the ear with lowest latency of wave V in ABR, are utilized in the final analysis. Absolute latencies of waves I, III, and V and inter peak latencies (IPL) I-III, III-V, I-V are recorded as the outcomes indicating neurodevelopment. The second phase of the study will be a clinical trial using the same infants from the first phase of the study. In this phase, infants with Feritin concentrations corresponding to aforementioned definition of Latent Iron Deficiency, i.e. 11-75 ng/mL, will be administered with 1 mg/kg iron drops (ferrous sulfate) from the start of the third week after birth until the end of the infant’s first month of life. At the end of the first month, ABR will be performed again and compared with the initial ABR.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201709019568N18
Registration date: 2017-09-30, 1396/07/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-09-30, 1396/07/08
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Maternal Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effects of Perinatal Iron Deficiency and Its Treatment on Auditory Brainstem Evoked Response in Neonates at Risk of Latent Iron Deficiency in the Vali-e Asr Hospital Maternity Ward
Public title
Effects of Iron administration on Auditory Brainstem Evoked Response in neonates at Risk of Latent Iron Deficiency
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Neonates with gestational ages>35 weeks and weight over 2,500 grshowing at least one of the risk factors for in utero Latent Iron Deficiency including maternal diabetes, maternal gestational hypertension, intrauterine growth restriction, and Serum Feritin levels between 11-75 ng/mL. Exclusion criteria: Neonates with craniofacial anomalies, chromosome abnormalities, hemolytic diseases, history of infectious disease in the third trimester, clinical evidence of chorioamnionitis, 5-minute Apgar scores<5, evidence of TORCH infections, clinical or laboratory diagnosed sepsis, history of hospitalization in the NICU due to any medical issue.
Age
From 14 days old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences,6 th floor of Tehran University of Medical Sciences,ghods St., Keshavarz blv,Tehran, Iran
City
Tehran
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
1396.3377

Health conditions studied

1

Description of health condition studied
Neonatal hearing impairment
ICD-10 code
H90.5
ICD-10 code description
Sensorineural hearing loss, unspecified

2

Description of health condition studied
Iron deficiency anemia
ICD-10 code
D-50
ICD-10 code description
anaemia

Primary outcomes

1

Description
neonatal hearing assessment
Timepoint
at birth and one month later
Method of measurement
ABR test

Secondary outcomes

empty

Intervention groups

1

Description
infants with Feritin concentrations corresponding to aforementioned definition of Latent Iron Deficiency, will be administered with 1 mg/kg iron drops (ferrous sulfate) from the start of the third week after birth until the end of the infant’s first month of life. At the end of the first month, ABR will be performed again and compared with the initial ABR.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Delivery Room, Vali e asr Hospital
Full name of responsible person
Dr. Elaheh Amini
Street address
Vali e asr Hospital,Imam Khomeini Hospital complexex, Keshavarz blv,14914, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Maternal, Fetal & Neonatal Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mamak Shariat
Street address
Vali e asr Hospital,Imam Khomeini Hospital complexex, Keshavarz blv,14914, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Maternal, Fetal & Neonatal Research Center, Tehran 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
Maternal Fetal and Neonatal Research Center
Full name of responsible person
Dr. Elaheh Amini
Position
Associate Professor
Other areas of specialty/work
Street address
Vali e asr Hospital,Imam Khomeini Hospital complexex, Keshavarz blv,14914, Tehran, Iran
City
Tehhran
Postal code
Phone
+98 21 6659 1316
Fax
Email
mfnhrc@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Maternal Fetal and Neonatal Research Center
Full name of responsible person
Dr Elaheh Amini
Position
Associate Professor
Other areas of specialty/work
Street address
Vali e asr Hospital,Imam Khomeini Hospital complexex, Keshavarz blv,14914, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6659 1316
Fax
Email
mfnhrc@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Maternal Fetal and Neonatal Research Center
Full name of responsible person
Dr. Elaheh Amini
Position
associate professor
Other areas of specialty/work
Street address
Vali e asr Hospital,Imam Khomeini Hospital complexex, Keshavarz blv,14914, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6659 1316
Fax
Email
mfnhrc@yahoo.com
Web page address

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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