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

Ain Shams University

Status: Completed

Conditions: Ductus Arteriosus

Treatments: Procedure: delayed cord clamping; Procedure: Umbilical cord milking

Study type: Interventional

Funder types: Other

Identifiers

NCT05922488

M D 75 / 2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Umbilical cord milking

Experimental group

Description:

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.

Treatment:

Procedure: Umbilical cord milking

delayed cord clamping

Experimental group

Description:

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.

Treatment:

Procedure: delayed cord clamping