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

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ClinicalTrials.gov Identifier: NCT04057027
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Turkish Neonatology Society
Information provided by (Responsible Party):
Merih Cetinkaya, 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.


Condition or disease Intervention/treatment Phase
Umbilical Cord; Clamping Time Procedure: Delayed umbilical cord clamping Procedure: Cord Milking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effect of Delayed Cord Clamping and Milking on the Amount of Endogenous Stem Cells In Preterm Infants
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : November 5, 2019
Estimated Study Completion Date : January 1, 2020

Arm Intervention/treatment
Experimental: Delayed Cord Clamping for 30 seconds
Infants whose umbilical cord clamping will be delayed for 30 secs.
Procedure: Delayed umbilical cord clamping
During the C section, infants' umbilical cord clamping will be delayed for 30-60 seconds.

Experimental: Delayed Cord Clamping for 60 seconds
Infants whose umbilical cord clamping will be delayed for 60 secs.
Procedure: Delayed umbilical cord clamping
During the C section, infants' umbilical cord clamping will be delayed for 30-60 seconds.

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




Primary Outcome Measures :
  1. Concentration of Stem cells [ Time Frame: 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 :
  1. Number of Participants with Neonatal Morbidities [ Time Frame: 6 months ]
    Recording newborn morbidities such as intraventricular hemorrhage , necrotizing enterocolitis, bronchopulmonary dysplasia , retinopathy of prematurity which are detected in the study population.



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Ages Eligible for Study:   up to 30 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057027


Contacts
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Contact: Seda Y Semerci 05337180683 sedayilmazsemerci@gmail.com

Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Turkish Neonatology Society

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Responsible Party: Merih Cetinkaya, Neonatologist, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04057027     History of Changes
Other Study ID Numbers: KAEK/2019.02.36
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No