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

Kanuni Sultan Suleyman Training and Research Hospital

Status: Unknown

Conditions: Umbilical Cord; Clamping Time

Treatments: Procedure: Cord Milking; Procedure: Delayed umbilical cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT04057027

KAEK/2019.02.36

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: Under 30 minutes old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Delayed Cord Clamping for 30 seconds

Experimental group

Description:

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

Treatment:

Procedure: Delayed umbilical cord clamping

Delayed Cord Clamping for 60 seconds

Experimental group

Description:

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

Treatment:

Procedure: Delayed umbilical cord clamping

Umbilical Cord Milking

Experimental group

Description:

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.

Treatment:

Procedure: Cord Milking