Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants
Primary Purpose
PreTerm Birth, Intraventricular Hemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Umbilical cord milking
Sponsored by
About this trial
This is an interventional supportive care trial for PreTerm Birth
Eligibility Criteria
Inclusion Criteria:
- Preterm infants < 32 weeks gestation confirmed by first trimester US
Exclusion Criteria:
- Any proven or suspected congenital or chromosomal abnormalities
- Placenta previa or abruption
- Cord prolapse
- Known Rh sensitization
- Fetal hydrops
- Monochorionic multiples
Sites / Locations
- King Abdulaziz University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Deferred Cord Clamping
Umbilical cord milking
Arm Description
Neonate is held at the level of placenta (level of introitus (vaginal delivery ) and mother's thigh or operating table (C/S) and cord clamping is deferred for 60 seconds.
Manually stripping 20cm of cord segment toward the umbilicus over a period of 2-3 seconds three times before cord clamping.
Outcomes
Primary Outcome Measures
Intraventricular haemorrhage
Any IVH diagnosed by cranial ultrasound
Secondary Outcome Measures
Need for resuscitation
Cardiac compression or medications at birth
Apgar score at one minute
Calculated Apgar score at one minute
Apgar score at 5 minutes
Calculated Apgar score at 5 minutes
The need for blood transfusion during hospital stay
The number of blood transfusions during hospital stay
Venous Hgb
Hgb at birth
Venous hematocrit
Hematocrit at birth
Bilirubin level
First bilirubin level after birth
Maximum bilirubin level
Highest bilirubin level
Polycythemia
If venous hematocrit more than 65%
Respiratory distress syndrome
The need for surfactant administration
Oxygen dependency
first 28 days after birth and/or 36 weeks corrected age
Need for volume administration
Need for bolus administration first 24 hours after birth
Use of inotropes
Use of any kind of inotropes in the first 24 hours
Necrotizing enterocolitis
Bell stage II or more
Mortality in hospital
Death before discharge
Sepsis
Positive blood culture
Maternal mortality
Maternal death after delivery in hospital
Post partum hemorrhage
Maternal estimated blood loss more than 500 mls in the first 24 hours after birth
Maternal need for blood transfusion
Maternal blood transfusion in the first 48 hours after delivery
Length of third stage
The time from delivery of the infant until delivery of placenta
Full Information
NCT ID
NCT02996799
First Posted
December 3, 2016
Last Updated
August 16, 2022
Sponsor
King Abdulaziz University
1. Study Identification
Unique Protocol Identification Number
NCT02996799
Brief Title
Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants
Official Title
Efficacy and Safety of Deferred Umbilical Cord Clamping Compared to Umbilical CordMilking in Preterm Infants: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.
Detailed Description
Contrary to delayed cord clamping, milking of the umbilical cord is done at a faster rate and in shorter time.Recent evidence has demonstrated the efficacy and safety of umbilical cord milking for both term and preterm infants.A newer evidence comparing delayed cord clamping to umbilical cord milking in preterm infants demonstrated a higher initial hemoglobin, blood pressure and systemic blood flow in preterm infants allocated to the umbilical cord milking arm.However, concerns have been raised with regard to rapid infusion of large volume of blood in relatively shorter time predisposing to hyperperfusion injury including intraventricular hemorrhage. This is particularly problematic for preterm neonates as they are at higher risk of neurological injury. It has, though, advantage of shorter timeframe allowing for effective resuscitation of preterm neonates to start as soon as possible. Thus, with countering advantages and disadvantages, the practice has not been adopted at most places. The authors planned to conduct a randomized clinical trail to compare the efficacy and safety of umbilical cord milking to deferred cord clamping in preterm infants less than 32 weeks gestation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreTerm Birth, Intraventricular Hemorrhage
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deferred Cord Clamping
Arm Type
No Intervention
Arm Description
Neonate is held at the level of placenta (level of introitus (vaginal delivery ) and mother's thigh or operating table (C/S) and cord clamping is deferred for 60 seconds.
Arm Title
Umbilical cord milking
Arm Type
Experimental
Arm Description
Manually stripping 20cm of cord segment toward the umbilicus over a period of 2-3 seconds three times before cord clamping.
Intervention Type
Other
Intervention Name(s)
Umbilical cord milking
Intervention Description
Milking of the umbilical cord at delivery
Primary Outcome Measure Information:
Title
Intraventricular haemorrhage
Description
Any IVH diagnosed by cranial ultrasound
Time Frame
twenty eight days
Secondary Outcome Measure Information:
Title
Need for resuscitation
Description
Cardiac compression or medications at birth
Time Frame
one hour
Title
Apgar score at one minute
Description
Calculated Apgar score at one minute
Time Frame
one minute after delivery
Title
Apgar score at 5 minutes
Description
Calculated Apgar score at 5 minutes
Time Frame
5 minutes after delivery
Title
The need for blood transfusion during hospital stay
Description
The number of blood transfusions during hospital stay
Time Frame
one month
Title
Venous Hgb
Description
Hgb at birth
Time Frame
2 days
Title
Venous hematocrit
Description
Hematocrit at birth
Time Frame
2 days
Title
Bilirubin level
Description
First bilirubin level after birth
Time Frame
24 hours after birth
Title
Maximum bilirubin level
Description
Highest bilirubin level
Time Frame
first week of life
Title
Polycythemia
Description
If venous hematocrit more than 65%
Time Frame
first 48 hours after birth
Title
Respiratory distress syndrome
Description
The need for surfactant administration
Time Frame
48 hours after birth
Title
Oxygen dependency
Description
first 28 days after birth and/or 36 weeks corrected age
Time Frame
first 28 days after birth and 36 weeks corrected age
Title
Need for volume administration
Description
Need for bolus administration first 24 hours after birth
Time Frame
24 hours after birth
Title
Use of inotropes
Description
Use of any kind of inotropes in the first 24 hours
Time Frame
First 24 hours
Title
Necrotizing enterocolitis
Description
Bell stage II or more
Time Frame
one month
Title
Mortality in hospital
Description
Death before discharge
Time Frame
one month
Title
Sepsis
Description
Positive blood culture
Time Frame
one month
Title
Maternal mortality
Description
Maternal death after delivery in hospital
Time Frame
2 weeks
Title
Post partum hemorrhage
Description
Maternal estimated blood loss more than 500 mls in the first 24 hours after birth
Time Frame
one day
Title
Maternal need for blood transfusion
Description
Maternal blood transfusion in the first 48 hours after delivery
Time Frame
First 48 hours after delivery
Title
Length of third stage
Description
The time from delivery of the infant until delivery of placenta
Time Frame
24 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm infants < 32 weeks gestation confirmed by first trimester US
Exclusion Criteria:
Any proven or suspected congenital or chromosomal abnormalities
Placenta previa or abruption
Cord prolapse
Known Rh sensitization
Fetal hydrops
Monochorionic multiples
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Al-Wassia
Phone
966544800441
Email
halwassia@kau.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Al-Wassia, MD
Organizational Affiliation
King Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdulaziz University Hospital
City
Jeddah
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Al-Wassia
Email
halwassia@kau.edu.sa
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We are planning to publish all the data that we will collect. If other researchers have specific questions about the data, we are willing to answer and share if needed.
IPD Sharing Time Frame
Data will be available upon request
IPD Sharing Access Criteria
Shared files
Learn more about this trial
Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants
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