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

Not Applicable

• Conditions: Umbilical Cord; Clamping Time
• Interventions: Procedure: Delayed umbilical cord clamping; Procedure: Cord Milking

• Registration Number: NCT04057027
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-14
• Study Start: 2019-09-15
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-07
• Primary Completion: 2020-09-05
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

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Exclusion Criteria

• Congenital abnormalities
• Chromosomal abnormalities
• Declined to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Cord Clamping for 30 seconds	Delayed umbilical cord clamping	Infants whose umbilical cord clamping will be delayed for 30 secs.
Delayed Cord Clamping for 60 seconds	Delayed umbilical cord clamping	Infants whose umbilical cord clamping will be delayed for 60 secs.
Umbilical Cord Milking	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.

Primary Outcome Measures

Name	Time	Method
Concentration of Stem cells	6 months	Determining the quantity of endogenous stem cells transmitted through the umbilical cord to the infant after different types of cord clamping.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Neonatal Morbidities	6 months	Recording newborn morbidities such as intraventricular hemorrhage , necrotizing enterocolitis, bronchopulmonary dysplasia , retinopathy of prematurity which are detected in the study population.

Trial Locations

Locations (1)

Istanbul Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey