In this study, 54 premature infants delivered via cesarean section and gestational age of less 32 weeks and birth weight of less than 1500 gram will randomly assign to two groups. The exclusion criteria are: congenital anomalies, maternal use of medications that interrupt with coagulative system, infant trauma, need for infant intensive resuscitation, twin pregnancy, breech presentation, maternal systemic diseases (preeclampsia, diabetes, hypertension ). The cord of 27 infants in the case group will be clamped after 30-45 seconds of birth and 27 infants in control group will have early cord clamping within first 10 seconds of life. All infants will have routine care for premature infants and will be evaluated for Intra ventricular using brain ultrasonography within third to seventh days of life. The rate of IVH will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091319145N1
Registration date:2014-12-01, 1393/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-01, 1393/09/10
Registrant information
Name
Afshin Khani
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0971
Email address
afshinkhani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research and technology of Babol University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study Of the Effect Of Delayed Versus Early Cord Clamping On The Incidence of Intra Ventricular Hemorrhage In Preterm Neonate
Public title
The Effect Of Delayed Cord Clamping On The Incidence Of Intra Ventricular Hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: Premature infants; delivered via cesarean section; Gestational age of less 32 weeks; Birth weight of less than 1500 gram
Exclusion Criteria: Congenital anomalies; Maternal use of medications that interrupt with coagulative system; Infant trauma; Need for infant intensive resuscitation; Twin pregnancy; Breech presentation; Maternal systemic diseases (preeclampsia, diabetes, hypertension )
Age
To 7 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
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
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz street, Keshvary Square, Babol
City
Babol
Postal code
Approval date
2014-01-21, 1392/11/01
Ethics committee reference number
/304709ژ/پ
Health conditions studied
1
Description of health condition studied
Intra Ventricular Hemorrhage
ICD-10 code
P52.3
ICD-10 code description
Unspecified intraventricular (non-traumatic) hemorrhage of fetus and newborn
Primary outcomes
1
Description
Intra Ventricular Hemorrhage
Timepoint
Days 3 to 7
Method of measurement
Brain Ultrasonography
2
Description
Survival of the infant
Timepoint
Every day up to 28 days
Method of measurement
Observing the neonate
Secondary outcomes
empty
Intervention groups
1
Description
Case: Cord clamping within 30 to 45 seconds of life
Category
Prevention
2
Description
Control: Cord clamping in the first 10 seconds of life
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Mobina Vrij Kazemi
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Aliakbar Moghadamnia
Street address
Deputy of Research and Technology, Babol University of Medical Sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mobina Vrijkazemi
Position
Nurse
Other areas of specialty/work
Street address
NICU ward, Ayatollah Rouhani Hospital
City
Babol
Postal code
Phone
+98 11 3223 8290
Fax
Email
baroon.vk@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohsen Haghshenas
Position
Neonatologist (MD)
Other areas of specialty/work
Street address
NICU ward, Ayatollah Rouhani Hospital, Babol University of Medical Sciences, Babol
City
Babol
Postal code
Phone
+98 11 3223 8290
Fax
Email
matia.mojaveri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Afshin Khani
Position
Student
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Babol
City
Babol
Postal code
Phone
00
Fax
Email
dr.afshinkhani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)