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

May 5, 2020 updated by: Merih Cetinkaya, Kanuni Sultan Suleyman Training and Research Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34303
        • Recruiting
        • Istanbul Kanuni Sultan Suleyman Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 minutes (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Collaborators

Turkish Neonatology Society

Investigators

  • Principal Investigator: Seda Yilmaz Semerci, Kanuni Sultan Süleyman Eah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2019

Primary Completion (Anticipated)

September 5, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

August 13, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2020

Last Update Submitted That Met QC Criteria

May 5, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • KAEK/2019.02.36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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