NCT05922488

Effect of Umbilical Cord Milking Versus Clamping in Preterms on Cerebral Oxygenation and Ductus Arteriosus Closure

Effect of Umbilical Cord Milking Versus Delayed Clamping in Preterm Infants on Cerebral Oxygenation and Ductus Arteriosus Closure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 48 Hours
• Healthy volunteers: Not accepted

Summary

All patients will be subjected to the following: 1-Umbilical cord milking or delayed cord clamping according to the ranamization table 2 serial measurement of cerebral tissue oxygenation 3- serial echocardiography for ductus arteriosus (DA)functional closure

Detailed description

* Study Population: neonates born and admitted to Ain shams university neonatal intensive care units (NICUs). * Inclusion criteria: o Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs. * Exclusion criteria: * Late preterm with gestational age 34-37 weeks. * Term infants with gestational age \> 37 weeks. * NIRS data that was not obtained within 1st hour after birth. * Congenital heart disease (other than DA or small atrial septal defects/patent foramen oval/ventriculi septal defects). * Hypoxic-ischemic insult. * Major congenital deformations. #All participants will be subjected to the following: * Infants will be considered to be randomized at the time of enrolment for: o Delayed cord clamping (DCC) and Umbilical cord milking (UCM) * Near-infrared spectroscopy (NIRS): * In the delivery room: after the intervention (UCM or DCC) the regional cerebral tissue oxygenation (rScO2 ) and cerebral fractional tissue oxygen extraction (c FTOE) will be collected for 10 minutes within 1st hour after birth. * In the neonatal intensive care unit: NIRS data will be collected for 2 hours at 12,24 hours, and 48 hours after birth. * Echocardiography: will be performed at 6, 12, 18, 24, and 48 hours of life by using an ultrasound Doppler machine Mindary.M9. assessment of DA functioning closure by measuring duct diameter and direction of blood flow through it.

Conditions

• Ductus Arteriosus

Interventions

Type	Name	Description
PROCEDURE	Umbilical cord milking	Umbilical cord milking : uncut umbilical cord and squeeze it from the placenta several times toward the infant usually within 20 seconds.
PROCEDURE	delayed cord clamping	delayed cord clamping: delivery the delivering obstetrician will wait at least 60 s before clamping the umbilical cord

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2023-06-28
• Last updated: 2023-06-28

Locations

1 site across 1 country: Egypt