NCT04057027

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2020

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

12 months

First QC Date

May 15, 2019

Last Update Submit

May 5, 2020

Conditions

Umbilical Cord; Clamping Time

Outcome Measures

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.

    6 months

Secondary Outcomes (1)

  • Number of Participants with Neonatal Morbidities

    6 months

Study Arms (3)

Delayed Cord Clamping for 30 seconds

EXPERIMENTAL

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

Procedure: Delayed umbilical cord clamping

Delayed Cord Clamping for 60 seconds

EXPERIMENTAL

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

Procedure: Delayed umbilical cord clamping

Umbilical Cord Milking

EXPERIMENTAL

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

Delayed umbilical cord clampingPROCEDURE

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

Delayed Cord Clamping for 30 secondsDelayed Cord Clamping for 60 seconds
Cord MilkingPROCEDURE

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

Umbilical Cord Milking

Eligibility Criteria

AgeUp to 30 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Congenital abnormalities
  • Chromosomal abnormalities
  • Declined to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Umbilical Cord Clamping

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Seda Yilmaz Semerci

    Kanuni Sultan Süleyman Eah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seda Yilmaz Semerci

CONTACT

05337180683sedayilmazsemerci@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatologist

Study Record Dates

First Submitted

May 15, 2019

First Posted

August 14, 2019

Study Start

September 15, 2019

Primary Completion

September 5, 2020

Study Completion

October 1, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)