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

Study Overview
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Brief Summary
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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.

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

Conditions
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Umbilical Cord; Clamping Time

Intervention / Treatment
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* Procedure: Delayed umbilical cord clamping
* Procedure: Cord Milking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 30 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delayed Cord Clamping for 30 seconds<br>Infants whose umbilical cord clamping will be delayed for 30 secs. | Procedure: Delayed umbilical cord clamping<br>* During the C section, infants' umbilical cord clamping will be delayed for 30-60 seconds.<br>|
| Experimental: Delayed Cord Clamping for 60 seconds<br>Infants whose umbilical cord clamping will be delayed for 60 secs. | Procedure: Delayed umbilical cord clamping<br>* During the C section, infants' umbilical cord clamping will be delayed for 30-60 seconds.<br>|
| Experimental: Umbilical Cord Milking<br>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. | Procedure: Cord Milking<br>* Umbilical cord will be milked from th distance of 20cm from mother's side to the baby, for 3-4 times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |