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

Ductus Arteriosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05922488
• Other study ID #: M D 75 / 2021
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: April 20, 2023

Study information

• Verified date: June 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Ductus Arteriosus
• Ductus Arteriosus, Patent

Intervention

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.
• delayed cord clamping
delayed cord clamping: delivery the delivering obstetrician will wait at least 60 s before clamping the umbilical cord

Locations

Country	Name	City	State
Egypt	Ainshams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of functional ductus arteriosus closure	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.	6, 12, 18, 24, and 48 hours of life
Secondary	changes in cerebral tissue oxygenation by NIRS.	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.	First hour of life for 10 minutes/ and for 2 hours on 12,24,84 hours of life
Secondary	ductus arteriosus diameter	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	6, 12, 18, 24, and 48 hours of life