Comparison of two methods of sudden and delayed umbilical cord cramps on hemoglobin levels in preterm infants 34-30 weeks old born in Hajar Hospital, Shahrekord
The effect of umbilical cord clamp delay on hemoglobin in preterm infants under 34 weeks
Design
Clinical trial with control group, with parallel groups, double-blind, simple approved (last dance of mother file number) on102 infants.
Settings and conduct
In this study, pregnant mothers who referred for a normal delivery; They were randomly divided into two groups: umbilical cord ligation immediately up to 30 seconds after birth and umbilical cord ligation at 30-60 seconds after birth. The mothers were unaware of the group in which they were placed. In this study, the facilitator and the researcher were aware of the interventions and only the statistical consultant was not aware of the type of intervention of the groups. The course of labor of the subjects was controlled and in the second stage of labor, no manual pressure was applied on the cervix to assist labor. After delivery, the umbilical cord in the control group immediately up to 30 seconds after birth and in the intervention group between 30-60 seconds after birth and while the baby is in the arms of the delivery method, it is level with the mother's heart; Clamped and disconnected
Participants/Inclusion and exclusion criteria
Infants with a birth age of 30-34 weeks are admitted to the study with parental consent
And infants in need of resuscitation immediately after birth and neonates born with twins and multiples and neonates born after traumatic and difficult births are excluded from the study.
Intervention groups
In the control group, the umbilical cord was clamped for less than 30 seconds and in the intervention group, the umbilical cord was clamped for 30 to 60 seconds.
Main outcome variables
Necrotizing enterocolitis
Need oxygen
Need phototherapy
Duration of hospitalization
Full feeding time
PDA
Hemoglobin level
Apgar score
General information
Reason for update
Acronym
DCC
IRCT registration information
IRCT registration number:IRCT20180915041040N4
Registration date:2021-04-12, 1400/01/23
Registration timing:registered_while_recruiting
Last update:2021-04-12, 1400/01/23
Update count:0
Registration date
2021-04-12, 1400/01/23
Registrant information
Name
Roya Choopani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
choopani.r@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-16, 1399/11/28
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of sudden and delayed umbilical cord cramps on hemoglobin levels in preterm infants 34-30 weeks old born in Hajar Hospital, Shahrekord
Public title
Delay umbilical cord clamping in premature infants
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants with GA 30-34 weeks age
Exclusion criteria:
The baby needs resuscitation immediately after birth
Babies born with twins and multiples
Babies born after a difficult and traumatic delivery
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
n this study, a table of random numbers is used. Infants with the right digit of the individual's maternal file number are in the control group (sudden umbilical cord clamp) and infants with the right digit of the pair of maternal file number are in the intervention group (delayed umbilical cord clamp).
Blinding (investigator's opinion)
Double blinded
Blinding description
En Parents of neonates and data analyzer and committee on safety and supervision of data were kept unaware of the groups their neonate was allocate to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Parastar
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815874119
Approval date
2021-02-15, 1399/11/27
Ethics committee reference number
IR.SKUMS.REC.1399.255
Health conditions studied
1
Description of health condition studied
Delay in cord clamping
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemoglobin level 3 hours, 48 hours and 6 weeks after birth
Timepoint
3 hours, 48 hours and 6 weeks after birth
Method of measurement
Hours
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Delay in umbilical cord clamp - umbilical cord closure was performed at 30-60 seconds after birth and the hematocrit and hemoglobin level of the infant was determined at 3 and 48 hours after birth. The neonatal Apgar score is determined at the end of the first and fifth minutes and parameters such as the incidence of necrotizing enterocolitis, duration of oxygen requirement, duration of phototherapy, length of hospital stay, time of full feeding (milk intake at 120 cc / kg / d -100), and the frequency of PDAs is also recorded
Category
N/A
2
Description
Control group: Umbilical cord clamp immediately after birth - Umbilical cord clamping was performed up to 30 seconds after birth and the infant's hematocrit and hemoglobin levels were determined at 3 and 48 hours after birth. The neonatal Apgar score is determined at the end of the first and fifth minutes and parameters such as the incidence of necrotizing enterocolitis, duration of oxygen demand, duration of phototherapy, length of hospital stay, time of full feeding (milk intake at 100-120 cc / kg / day), and the frequency of PDAs is also recorded
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Roya Choupani
Street address
Parastar
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
886854633
Phone
+98 38 3222 0016
Fax
+98 38 3224 3715
Email
choopani.r@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Mehraban Sadeghi
Street address
Kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 2414
Email
vcrt@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya-choupani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar
City
Sharkord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 0016
Email
dr.choopani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choupani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
dr.choopani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Roya Choupani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
dr.choopani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts from 1400
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in future research only
From where data/document is obtainable
Applicants should contact the researcher at dr.choopani@yahoo.com or call 03832220016 ext.
What processes are involved for a request to access data/document
The researcher is obliged to provide the documents to the applicant as soon as possible after contacting the applicant or after correspondence by e-mail.