Umbilical Cord; Clamping TimeNCT04057027
The Effect of Delayed Cord Clamping and Milking on the Amount of Stem Cells In Preterm
A study testing Delayed umbilical cord clamping and Cord Milking in people with Umbilical Cord; Clamping Time, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Stem cell therapies have been promising therapies in neonatal morbidities such as bronchopulmonary dysplasia, intraventricular hemorrhage and hypoxic ischemic encephalopathy. Although researchers showed those effects by several mechanisms including paracrine effect, regenerative and restorative effects, there is no… Read more about this study
- Who is it for?
- Ages Up to 30 minutesHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord; Clamping Time
- What is being tested?
- Delayed umbilical cord clamping and Cord Milking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2019to 1 Oct 2020
- 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 30 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born under 32 weeks of gestation
- Accepted to participate with informed consent
- History of healthy pregnancy
- Infants born and will be followed up at the study hospital
Who cannot join
- Congenital abnormalities
- Chromosomal abnormalities
- Declined to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34303
Seda Yilmaz Semerci, 05337180683, sedayilmazsemerci@gmail.com
About this study
Official title: The Effect of Delayed Cord Clamping and Milking on the Amount of Endogenous Stem Cells In Preterm Infants
Stem cell therapies have been promising therapies in neonatal morbidities such as bronchopulmonary dysplasia, intraventricular hemorrhage and hypoxic ischemic encephalopathy. Although researchers showed those effects by several mechanisms including paracrine effect, regenerative and restorative effects, there is no obvious recommendations for the type of stem cells, dosage or the route of administration the cells. The usage of exogenous stem cells can be difficult due to technical issues in preterm infants.
In the presence of these data, the amount of endogenous stem cells passing through the cord to the infant may show differences in terms of delayed cord clamping and milking. Therefore the aim of this prospective randomized study is to determine the quantity of the stem cells according to delayed cord clamping or cord milking. We also aimed to evaluate the association between the number of stem cells and neonatal morbidities.
- Conditions
- Umbilical Cord; Clamping Time
- Being tested
- Delayed umbilical cord clamping, Cord Milking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed umbilical cord clampingProcedure or surgery
During the C section, infants' umbilical cord clamping will be delayed for 30-60 seconds.
Cord MilkingProcedure or surgery
Umbilical cord will be milked from th distance of 20cm from mother's side to the baby, for 3-4 times.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Cord Clamping for 30 seconds | Experimental | Infants whose umbilical cord clamping will be delayed for 30 secs. Receives: Procedure: Delayed umbilical cord clamping |
| Delayed Cord Clamping for 60 seconds | Experimental | Infants whose umbilical cord clamping will be delayed for 60 secs. Receives: Procedure: Delayed umbilical cord clamping |
| Umbilical Cord Milking | Experimental | Infants whose umbilical cord will be clamped after milking from the distance of 20 cm from mother's side to the baby for 3-4 times. Receives: Procedure: Cord Milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Stem cells
Determining the quantity of endogenous stem cells transmitted through the umbilical cord to the infant after different types of cord clamping.
Measured: 6 months
Secondary outcomes (1)
Number of Participants with Neonatal Morbidities
Recording newborn morbidities such as intraventricular hemorrhage , necrotizing enterocolitis, bronchopulmonary dysplasia , retinopathy of prematurity which are detected in the study population.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start15 Sep 2019
- Primary completion5 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical Cord; Clamping TimeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Neonatology Society
- Responsible party
- Principal investigator, Merih Cetinkaya, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Seda Yilmaz Semerci, Principal investigator, Kanuni Sultan Süleyman Eah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057027
- Sponsor's protocol ID
- KAEK/2019.02.36
- Status last verified
- May 2020
- First submitted
- 15 May 2019
- Last updated
- 7 May 2020
- Results posted
- 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 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Delayed Cord Clamping and Milking on the Amount of Endogenous Stem Cells In Preterm Infants
- ClinicalTrials.gov ID
- NCT04057027
- Acronym / sponsor ID
- KAEK/2019.02.36
- Conditions
- Umbilical Cord; Clamping Time
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- Turkish Neonatology Society
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 5 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 14 Aug 2019 (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.
Stem cell therapies have been promising therapies in neonatal morbidities such as bronchopulmonary dysplasia, intraventricular hemorrhage and hypoxic ischemic encephalopathy. Although researchers showed those effects by several mechanisms including paracrine effect, regenerative and restorative effects, there is no obvious recommendations for the type of stem cells, dosage or the route of administration the cells. The usage of exogenous stem cells can be difficult due to technical issues in preterm infants.
In the presence of these data, the amount of endogenous stem cells passing through the cord to the infant may show differences in terms of delayed cord clamping and milking. Therefore the aim of this prospective randomized study is to determine the quantity of the stem cells according to delayed cord clamping or cord milking. We also aimed to evaluate the association between the number of stem cells and neonatal morbidities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delayed Cord Clamping for 30 seconds | Experimental | Procedure: Delayed umbilical cord clampingInfants whose umbilical cord clamping will be delayed for 30 secs. |
| Delayed Cord Clamping for 60 seconds | Experimental | Procedure: Delayed umbilical cord clampingInfants whose umbilical cord clamping will be delayed for 60 secs. |
| Umbilical Cord Milking | Experimental | Procedure: Cord MilkingInfants whose umbilical cord will be clamped after milking from the distance of 20 cm from mother's side to the baby for 3-4 times. |
Who may qualify
- Ages
- Up to 30 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants born under 32 weeks of gestation
- Accepted to participate with informed consent
- History of healthy pregnancy
- Infants born and will be followed up at the study hospital
Key exclusion criteria (3 listed)
- Congenital abnormalities
- Chromosomal abnormalities
- Declined to participate
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 |
|---|---|---|
| Delayed umbilical cord clampingDuring the C section, infants' umbilical cord clamping will be delayed for 30-60 seconds. | Procedure or surgery | Delayed Cord Clamping for 30 seconds, Delayed Cord Clamping for 60 seconds |
| Cord MilkingUmbilical cord will be milked from th distance of 20cm from mother's side to the baby, for 3-4 times. | Procedure or surgery | Umbilical Cord Milking |
Primary outcome
Concentration of Stem cells
Time frame: 6 months
Determining the quantity of endogenous stem cells transmitted through the umbilical cord to the infant after different types of cord clamping.
1 secondary outcome
Number of Participants with Neonatal Morbidities
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No
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.
Seda Yilmaz Semerci principal investigator
Kanuni Sultan Süleyman Eah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed umbilical cord clamping and Cord Milking in people with Umbilical Cord; Clamping Time, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 May 2020. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seda Yilmaz Semerci (05337180683, sedayilmazsemerci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Stem cells (time frame: 6 months). 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 7 May 2020.