Umbilical Cord; Clamping Time Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 90 |
| Est. completion date | October 1, 2020 |
| Est. primary completion date | September 5, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A to 30 Minutes |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Istanbul Kanuni Sultan Suleyman Training and Research Hospital | Istanbul |
| Lead Sponsor | Collaborator |
|---|---|
| Kanuni Sultan Suleyman Training and Research Hospital | Turkish Neonatology Society |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 6 months | |
| Secondary | 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. | 6 months |