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Effect of Umbilical Cord Milking Versus Clamping in Preterms on Cerebral Oxygenation and Ductus Arteriosus Closure

Primary Purpose

Ductus Arteriosus

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Umbilical cord milking
delayed cord clamping
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ductus Arteriosus focused on measuring Cerebral tissue oxygenation, Functional Ductus arteriosus closure, Umbilical cord milking, Delayed cord clamping

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs. Exclusion Criteria: Late preterm with gestational age 35-37 weeks. Term infants with gestational age > 37weeks. NIRS data that not obtained within 1sthour after birth. Congenital heart disease (other than PDA or small atrial septal defects/patent foramen oval/muscularventriculoseptal defects). Hypoxic-ischemic insult. Major congenital deformations.

Sites / Locations

  • Ainshams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Umbilical cord milking

delayed cord clamping

Arm Description

In the cesarean section or vaginal delivery, the obstetrician will gently grasp the uncut umbilical cord and squeeze it from the placenta several times toward the infant usually within 20 seconds.

In the cesarean section or vaginal delivery the delivering obstetrician will wait at least 60 s before clamping the umbilical cord. Infants will be dried and will be given gentle tactile stimulation to promote the respiratory effort.

Outcomes

Primary Outcome Measures

time of functional ductus arteriosus closure
performed by follow-up echocardiography using machine Mindary.M9 measuring changes from the baseline blood flow direction through the ductus arteriosus (DA) at 6, 12, 18, 24, 48 hours of life that helps to determine at which time the functional closure of ductus arteriosus occurs.

Secondary Outcome Measures

changes in cerebral tissue oxygenation by NIRS.
Cerebral tissue oxygenation measurement using Near-infrared spectroscopy (NIRS): In the delivery room: after the intervention (UCM or DCC), rScO2 and cFTOE will be collected for 10 minutes within 1st hour after birth. In the neonatal intensive care unit: NIRS data will be collected for 2 hours at 12,24 hours, and 48 hours after birth.
ductus arteriosus diameter
performed by follow-up echocardiography at 6, 12, 18, 24, and 48 hours of life by using an ultrasound Doppler machine Mindary.M9 comparing changes that occur in the ductus arteriosus diameter from the baseline

Full Information

First Posted
April 26, 2023
Last Updated
June 19, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05922488
Brief Title
Effect of Umbilical Cord Milking Versus Clamping in Preterms on Cerebral Oxygenation and Ductus Arteriosus Closure
Official Title
Effect of Umbilical Cord Milking Versus Delayed Clamping in Preterm Infants on Cerebral Oxygenation and Ductus Arteriosus Closure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
All patients will be subjected to the following: 1-Umbilical cord milking or delayed cord clamping according to the ranamization table 2 serial measurement of cerebral tissue oxygenation 3- serial echocardiography for ductus arteriosus (DA)functional closure
Detailed Description
Study Population: neonates born and admitted to Ain shams university neonatal intensive care units (NICUs). Inclusion criteria: o Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs. Exclusion criteria: Late preterm with gestational age 34-37 weeks. Term infants with gestational age > 37 weeks. NIRS data that was not obtained within 1st hour after birth. Congenital heart disease (other than DA or small atrial septal defects/patent foramen oval/ventriculi septal defects). Hypoxic-ischemic insult. Major congenital deformations. #All participants will be subjected to the following: Infants will be considered to be randomized at the time of enrolment for: o Delayed cord clamping (DCC) and Umbilical cord milking (UCM) Near-infrared spectroscopy (NIRS): In the delivery room: after the intervention (UCM or DCC) the regional cerebral tissue oxygenation (rScO2 ) and cerebral fractional tissue oxygen extraction (c FTOE) will be collected for 10 minutes within 1st hour after birth. In the neonatal intensive care unit: NIRS data will be collected for 2 hours at 12,24 hours, and 48 hours after birth. Echocardiography: will be performed at 6, 12, 18, 24, and 48 hours of life by using an ultrasound Doppler machine Mindary.M9. assessment of DA functioning closure by measuring duct diameter and direction of blood flow through it.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductus Arteriosus
Keywords
Cerebral tissue oxygenation, Functional Ductus arteriosus closure, Umbilical cord milking, Delayed cord clamping

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
all involved neonates will be randomized to DCC or UCM according to the randomization table and double-blinded method.
Masking
None (Open Label)
Masking Description
all involved neonates will be randomized to DCC or UCM according to the randomization table and double-blinded method.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Umbilical cord milking
Arm Type
Experimental
Arm Description
In the cesarean section or vaginal delivery, the obstetrician will gently grasp the uncut umbilical cord and squeeze it from the placenta several times toward the infant usually within 20 seconds.
Arm Title
delayed cord clamping
Arm Type
Experimental
Arm Description
In the cesarean section or vaginal delivery the delivering obstetrician will wait at least 60 s before clamping the umbilical cord. Infants will be dried and will be given gentle tactile stimulation to promote the respiratory effort.
Intervention Type
Procedure
Intervention Name(s)
Umbilical cord milking
Intervention Description
Umbilical cord milking : uncut umbilical cord and squeeze it from the placenta several times toward the infant usually within 20 seconds.
Intervention Type
Procedure
Intervention Name(s)
delayed cord clamping
Intervention Description
delayed cord clamping: delivery the delivering obstetrician will wait at least 60 s before clamping the umbilical cord
Primary Outcome Measure Information:
Title
time of functional ductus arteriosus closure
Description
performed by follow-up echocardiography using machine Mindary.M9 measuring changes from the baseline blood flow direction through the ductus arteriosus (DA) at 6, 12, 18, 24, 48 hours of life that helps to determine at which time the functional closure of ductus arteriosus occurs.
Time Frame
6, 12, 18, 24, and 48 hours of life
Secondary Outcome Measure Information:
Title
changes in cerebral tissue oxygenation by NIRS.
Description
Cerebral tissue oxygenation measurement using Near-infrared spectroscopy (NIRS): In the delivery room: after the intervention (UCM or DCC), rScO2 and cFTOE will be collected for 10 minutes within 1st hour after birth. In the neonatal intensive care unit: NIRS data will be collected for 2 hours at 12,24 hours, and 48 hours after birth.
Time Frame
First hour of life for 10 minutes/ and for 2 hours on 12,24,84 hours of life
Title
ductus arteriosus diameter
Description
performed by follow-up echocardiography at 6, 12, 18, 24, and 48 hours of life by using an ultrasound Doppler machine Mindary.M9 comparing changes that occur in the ductus arteriosus diameter from the baseline
Time Frame
6, 12, 18, 24, and 48 hours of life

10. Eligibility

Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs. Exclusion Criteria: Late preterm with gestational age 35-37 weeks. Term infants with gestational age > 37weeks. NIRS data that not obtained within 1sthour after birth. Congenital heart disease (other than PDA or small atrial septal defects/patent foramen oval/muscularventriculoseptal defects). Hypoxic-ischemic insult. Major congenital deformations.
Facility Information:
Facility Name
Ainshams university
City
Cairo
ZIP/Postal Code
11517
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Umbilical Cord Milking Versus Clamping in Preterms on Cerebral Oxygenation and Ductus Arteriosus Closure

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