Umbilical Cord Clamping Methods and Stem Cell Counts in Preterm Infants

Era Tufan Benli

Status: Completed

Conditions: Umbilical Cord Clamping; Preterm Birth

Treatments: Procedure: Delayed Cord Clamping; Procedure: Immediate Cord Clamping; Procedure: Umbilical Cord Milking

Study type: Interventional

Funder types: Other

Identifiers

NCT07385326

SUCCH-UCC-2015

Details and patient eligibility

About

This study evaluates the effect of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns.

Preterm infants were randomly assigned to different umbilical cord clamping strategies as part of routine obstetric care. Peripheral blood samples were collected after birth to assess stem cell concentrations.

The aim of the study was to determine whether physiological cord management strategies could influence early hematologic adaptation in preterm infants. The study was conducted using standard clinical procedures without additional intervention beyond routine care.

Full description

This prospective randomized study was conducted to investigate the impact of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns.

Eligible preterm infants were randomly allocated to one of the predefined umbilical cord clamping strategies according to the study protocol. All procedures were performed as part of standard obstetric and neonatal care, and no experimental intervention outside routine clinical practice was applied.

Peripheral blood samples were obtained following delivery, and hematopoietic stem cell concentrations were analyzed using standard laboratory methods. The primary outcome was the comparison of stem cell counts between the different cord clamping groups.

The study was initiated and completed in 2015, prior to mandatory prospective clinical trial registration requirements. Ethical approval was obtained from the relevant institutional ethics committee, and informed consent was obtained from parents or legal guardians before participation.

Enrollment: 49 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Preterm neonates born between 28+0 and 36+6 weeks of gestation.
• Infants born at a single tertiary referral center.
• Written informed consent obtained from parents prior to delivery.

Exclusion criteria

• Major fetal congenital anomalies.
• Perinatal asphyxia.
• Requirement for advanced neonatal resuscitation at birth.
• Undetermined gestational age.
• Gestational age less than 28 weeks.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 3 patient groups

Immediate Cord Clamping (ICC)

Experimental group

Description:

Umbilical cord clamped within 30 seconds after birth.

Treatment:

Procedure: Immediate Cord Clamping

Delayed Cord Clamping (DCC)

Experimental group

Description:

Umbilical cord clamped 60 seconds after birth.

Treatment:

Procedure: Delayed Cord Clamping

Umbilical Cord Milking (UCM)

Experimental group

Description:

Umbilical cord milked toward the infant before clamping.

Treatment:

Procedure: Umbilical Cord Milking