The Effect of Delayed Cord Clamping and Milking on the Amount of Stem Cells In Preterm

NCT ID: NCT04057027

Last Updated: 2020-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-15

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Umbilical Cord; Clamping Time

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Delayed Cord Clamping for 30 seconds

Infants whose umbilical cord clamping will be delayed for 30 secs.

Group Type EXPERIMENTAL

Delayed umbilical cord clamping

Intervention Type PROCEDURE

During the C section, infants' umbilical cord clamping will be delayed for 30-60 seconds.

Delayed Cord Clamping for 60 seconds

Infants whose umbilical cord clamping will be delayed for 60 secs.

Group Type EXPERIMENTAL

Delayed umbilical cord clamping

Intervention Type PROCEDURE

During the C section, infants' umbilical cord clamping will be delayed for 30-60 seconds.

Umbilical Cord Milking

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.

Group Type EXPERIMENTAL

Cord Milking

Intervention Type PROCEDURE

Umbilical cord will be milked from th distance of 20cm from mother's side to the baby, for 3-4 times.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Delayed umbilical cord clamping

During the C section, infants' umbilical cord clamping will be delayed for 30-60 seconds.

Intervention Type PROCEDURE

Cord Milking

Umbilical cord will be milked from th distance of 20cm from mother's side to the baby, for 3-4 times.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Congenital abnormalities
* Chromosomal abnormalities
* Declined to participate
Maximum Eligible Age

30 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Turkish Neonatology Society

OTHER

Sponsor Role collaborator

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Merih Cetinkaya

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Seda Yilmaz Semerci

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Süleyman Eah

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Seda Yilmaz Semerci

Role: CONTACT

05337180683

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Seda Yilmaz Semerci

Role: primary

05337180683

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KAEK/2019.02.36

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Delayed Cord Clamping in VLBW Infants
NCT01222364 COMPLETED PHASE1/PHASE2
Warmed Blood Transfusion in Premature Infants
NCT06425783 ACTIVE_NOT_RECRUITING NA