Ductus ArteriosusNCT05922488
Effect of Umbilical Cord Milking Versus Clamping in Preterms on Cerebral Oxygenation and Ductus Arteriosus Closure
A study testing Umbilical cord milking and delayed cord clamping in people with Ductus Arteriosus, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Ductus Arteriosus
- What is being tested?
- Umbilical cord milking and delayed cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Umbilical Cord Milking Versus Delayed Clamping in Preterm Infants on Cerebral Oxygenation and Ductus Arteriosus Closure
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
Read the detailed description
- Study Population: neonates born and admitted to Ain shams university neonatal intensive care units (NICUs).
- 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 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:
- 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.
- Conditions
- Ductus Arteriosus
- Being tested
- Umbilical cord milking, delayed cord clamping
- Keywords
- Cerebral tissue oxygenation, Functional Ductus arteriosus closure, Umbilical cord milking, Delayed cord clamping
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord milkingProcedure or surgery
Umbilical cord milking : uncut umbilical cord and squeeze it from the placenta several times toward the infant usually within 20 seconds.
delayed cord clampingProcedure or surgery
delayed cord clamping: delivery the delivering obstetrician will wait at least 60 s before clamping the umbilical cord
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord milking | Experimental | 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. Receives: Procedure: Umbilical cord milking |
| delayed cord clamping | Experimental | 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. Receives: Procedure: delayed cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6, 12, 18, 24, and 48 hours of life
Secondary outcomes (2)
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.
Measured: First hour of life for 10 minutes/ and for 2 hours on 12,24,84 hours of life
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
Measured: 6, 12, 18, 24, and 48 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Dec 2021
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa M Madkoor, MD [walaa madkoor], Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922488
- Sponsor's protocol ID
- M D 75 / 2021
- Status last verified
- Jun 2023
- First submitted
- 26 Apr 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Umbilical Cord Milking Versus Delayed Clamping in Preterm Infants on Cerebral Oxygenation and Ductus Arteriosus Closure
- ClinicalTrials.gov ID
- NCT05922488
- Acronym / sponsor ID
- M D 75 / 2021
- Conditions
- Ductus Arteriosus
- Keywords
- Cerebral tissue oxygenation, Functional Ductus arteriosus closure, Umbilical cord milking, Delayed cord clamping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- all involved neonates will be randomized to DCC or UCM according to the randomization table and double-blinded method.
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord milking | Experimental | Procedure: Umbilical cord milkingIn 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. |
| delayed cord clamping | Experimental | Procedure: delayed cord clampingIn 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. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs.
Key exclusion criteria (6 listed)
- Late preterm with gestational age 35-37 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord milkingUmbilical cord milking : uncut umbilical cord and squeeze it from the placenta several times toward the infant usually within 20 seconds. | Procedure or surgery | Umbilical cord milking |
| delayed cord clampingdelayed cord clamping: delivery the delivering obstetrician will wait at least 60 s before clamping the umbilical cord | Procedure or surgery | delayed cord clamping |
Primary outcome
time of functional ductus arteriosus closure
Time frame: 6, 12, 18, 24, and 48 hours of life
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.
2 secondary outcomes
changes in cerebral tissue oxygenation by NIRS.
Time frame: First hour of life for 10 minutes/ and for 2 hours on 12,24,84 hours of life
ductus arteriosus diameter
Time frame: 6, 12, 18, 24, and 48 hours of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord milking and delayed cord clamping in people with Ductus Arteriosus, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of functional ductus arteriosus closure (time frame: 6, 12, 18, 24, and 48 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.