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

Not Applicable

Completed

• Conditions: Ductus Arteriosus
• Interventions: Procedure: Umbilical cord milking; Procedure: delayed cord clamping

• Registration Number: NCT05922488
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Study First Submitted: 2023-04-26
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-19
• Last Update Submitted: 2023-06-19
• Study First Posted: 2023-06-28
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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 35-37 weeks.

  • Term infants with gestational age > 37weeks.
  • NIRS data that not obtained within 1sthour after birth.
  • Congenital heart disease (other than PDA or small atrial septal defects/patent foramen oval/muscularventriculoseptal defects).
  • Hypoxic-ischemic insult.
  • Major congenital deformations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umbilical cord milking	Umbilical cord milking	In the cesarean section or vaginal delivery, the obstetrician will gently grasp the uncut umbilical cord and squeeze it from the placenta several times toward the infant usually within 20 seconds.
delayed cord clamping	delayed cord clamping	In the cesarean section or vaginal delivery the delivering obstetrician will wait at least 60 s before clamping the umbilical cord. Infants will be dried and will be given gentle tactile stimulation to promote the respiratory effort.

Primary Outcome Measures

Name	Time	Method
time of functional ductus arteriosus closure	6, 12, 18, 24, and 48 hours of life	performed by follow-up echocardiography using machine Mindary.M9 measuring changes from the baseline blood flow direction through the ductus arteriosus (DA) at 6, 12, 18, 24, 48 hours of life that helps to determine at which time the functional closure of ductus arteriosus occurs.

Secondary Outcome Measures

Name	Time	Method
changes in cerebral tissue oxygenation by NIRS.	First hour of life for 10 minutes/ and for 2 hours on 12,24,84 hours of life	Cerebral tissue oxygenation measurement using Near-infrared spectroscopy (NIRS): * In the delivery room: after the intervention (UCM or DCC), rScO2 and cFTOE 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.
ductus arteriosus diameter	6, 12, 18, 24, and 48 hours of life	performed by follow-up echocardiography at 6, 12, 18, 24, and 48 hours of life by using an ultrasound Doppler machine Mindary.M9 comparing changes that occur in the ductus arteriosus diameter from the baseline

Trial Locations

Locations (1)

Ainshams university; 🇪🇬 Cairo, Egypt