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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04057027
Enrollment
90
Registered
2019-08-14
Start date
2019-09-15
Completion date
2020-10-01
Last updated
2020-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Umbilical Cord; Clamping Time

Brief 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 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.

Interventions

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

PROCEDURECord Milking

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

Sponsors

Turkish Neonatology Society
CollaboratorOTHER
Kanuni Sultan Suleyman Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Minutes
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Concentration of Stem cells6 monthsDetermining the quantity of endogenous stem cells transmitted through the umbilical cord to the infant after different types of cord clamping.

Secondary

MeasureTime frameDescription
Number of Participants with Neonatal Morbidities6 monthsRecording newborn morbidities such as intraventricular hemorrhage , necrotizing enterocolitis, bronchopulmonary dysplasia , retinopathy of prematurity which are detected in the study population.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSeda Yilmaz Semerci
sedayilmazsemerci@gmail.com05337180683

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026