Preterm Birth, Umbilical Cord Clamping
Conditions
Keywords
Preterm newborn, Umbilical cord clamping, Hematopoietic stem cells, Peripheral blood, Randomized study
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREImmediate Cord Clamping
Clamping of the umbilical cord within 30 seconds after delivery.
PROCEDUREDelayed Cord Clamping
Clamping of the umbilical cord 60 seconds after delivery.
PROCEDUREUmbilical Cord Milking
Milking of a 20 cm segment of the umbilical cord toward the infant before clamping.
Sponsors
Era Tufan Benli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Outcome assessors were blinded to group allocation.
Intervention model description
Participants were randomly assigned to three parallel groups based on umbilical cord management method.
Eligibility
Sex/Gender
ALL
Age
0 Days to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Hemoglobin Level | Within first 24 hours after birth | Comparison of neonatal hemoglobin levels among immediate cord clamping, delayed cord clamping, and umbilical cord milking groups. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORMeryem Ceyhan, Dr.
Department of Gynecology and Obstetrics, Lokman Hekim University, Faculty of Medicine,
Outcome results
None listed