The aim of present study is determining the effect of cord milking, delayed and early cord clamping on preterm infant outcome such as intraventricular hemorrhage, bronchopulmonary dysplasia and blood transfusion and to detect the best method of cord clamp in these infants.
Design
In a randomized controlled clinical trial 90 neonates randomly allocate in three groups. Cord clamping performs in three different methods: routine , delayed clamping and cord milking. Enrolled infants follow till discharge to determine their outcome including need to blood transfusion, intraventricular hemorrhage and need to supplemental oxygen.
Settings and conduct
The study is done in Alzahra Hospital, a referral tertiary university hospital. The aid of labor perform cord clamp according random number list. Admission nurse in nursery, the physician that manage the neonates and outcome recorder are blind about patients groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include preterm infants with gestation age 28-30 weeks; birth weight less than 1500 grams.
Non- inclusion criteria include Infants with congenital anomalies; placenta previa; decolman; parental refuse or need to immediate maternal or neonatal resuscitation.
Intervention groups
In control group: routine cord clamping is done 10 seconds after birth. In intervention group1: delayed cord clamp is done 30-60 seconds after birth and in intervention group2: cord milking is done from 20 ±2 cm toward the neonate for 20 seconds three times.
Main outcome variables
Intraventricular hemorrhage; Bronchopulmonary dysplasia; Anemia of prematurity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100512003915N22
Registration date:2019-04-27, 1398/02/07
Registration timing:registered_while_recruiting
Last update:2019-04-27, 1398/02/07
Update count:0
Registration date
2019-04-27, 1398/02/07
Registrant information
Name
Manizheh Mostafa Gharehbaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2253
Email address
peirovifara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the short term outcome of preterm infants with three different umbilical cord clamping methods
Public title
the short term outcome of three different umbilical cord clamping methods
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
preterm infants with gestation age less than 28-30 weeks
birth weight less than 1250
Exclusion criteria:
placenta previa
decolman
need to emergent resuscitation of mother or neonate
parental refuse
congenital anomalies
Age
From 1 day old to 28 days old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Preterm infants randomly allocated in three groups by random number list generator based on their arrive in delivery room.
Blinding (investigator's opinion)
Double blinded
Blinding description
Nurses who admit these infants , the nonatologists who manage the patients in NICU and outcome recorder are blind to groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences. Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR. TBZMED.REC.1397.1076
Health conditions studied
1
Description of health condition studied
Anemia of prematurity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intra-ventricular hemorrhage
Timepoint
At 3-5 days after birth and 28 days
Method of measurement
Brain sonography
2
Description
Bronchopulmonary dysplasia
Timepoint
One month after birth and at discharge
Method of measurement
Need to supplemental oxygen based on pulse oxymetry
Secondary outcomes
1
Description
Anemia of prematurity
Timepoint
Discharge
Method of measurement
The numbers of blood transfusions
2
Description
Intra-ventricular hemorrhage
Timepoint
At 3-5 days and at 28 days of birth
Method of measurement
Brain sonography
3
Description
Bronchopulmonary dysplasia
Timepoint
One month after birth
Method of measurement
Need to supplemental oxygen
Intervention groups
1
Description
Intervention group: Delayed cord clamp within 30-60 sec of delivery
Category
Other
2
Description
Intervention group: Cord milking toward neonate from 20 centimeter for 20 seconds 3 times
Category
Other
3
Description
Control group: Routine cord clamp within 10 seconds of delivery
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Sanaz Yasrebi nia
Street address
South Artesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3553 9161
Email
gharehbaghimm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Joyban
Street address
Tabriz University of Medical Sciences. Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Yasrebi nia
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Azahra Hospital. South Artesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3553 9161
Email
gharehbaghimm@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Gharehbaghi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Alzahra Hospital. South Atesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3553 9161
Email
gharehbaghimm@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Yasrebinia
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Alzahra Hospital. South Artesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3553 9161
Email
gharehbaghimm@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
No additional data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available