CClinicalTrials.gg
Status unknownNCT04057027Updated May 7, 2020

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

An interventional study of Delayed umbilical cord clamping and Cord Milking in Umbilical Cord; Clamping Time, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged Up to 30 Minutes, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-07.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
Up to 30 Minutes
Sex
All
01

Study 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.

02

Conditions studied

  • Umbilical Cord; Clamping Time
03

In context

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 30 Minutes
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Congenital abnormalities
  • Chromosomal abnormalities
  • Declined to participate
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Delayed Cord Clamping for 30 seconds

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

    Procedure: Delayed umbilical cord clamping

  • Experimental
    Delayed Cord Clamping for 60 seconds

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

    Procedure: Delayed umbilical cord clamping

  • 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

Interventions

  • ProcedureDelayed umbilical cord clamping

    During the C section, infants' umbilical cord clamping will be delayed for 30-60 seconds.

  • ProcedureCord Milking

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Istanbul Kanuni Sultan Suleyman Training and Research Hospital
    Istanbul, 34303, Turkey
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04057027
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Collaborators
Turkish Neonatology Society
Responsible party
Merih Cetinkaya (Neonatologist, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Aug 14, 2019
Start date
Sep 15, 2019
Primary completion
Sep 5, 2020 (estimated)
Completion
Oct 1, 2020 (estimated)
Last update
May 7, 2020

Study contacts

Seda Yilmaz Semerci
Contact
sedayilmazsemerci@gmail.com
05337180683
Seda Yilmaz Semerci
principal investigator · Kanuni Sultan Süleyman Eah

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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