Clinical trial NCT05922488: Effect of Umbilical Cord Milking Versus Clamping in Preterms on Cerebral Oxygenation and Ductus Arteriosus Closure
Official title: Effect of Umbilical Cord Milking Versus Delayed Clamping in Preterm Infants on Cerebral Oxygenation and Ductus Arteriosus Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ductus Arteriosus
Keywords: Cerebral tissue oxygenation
Functional Ductus arteriosus closure
Umbilical cord milking
Delayed cord clamping
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 100
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: all involved neonates will be randomized to DCC or UCM according to the randomization table and double-blinded method.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: time of functional ductus arteriosus closure
timeFrame: 6, 12, 18, 24, and 48 hours of life
Secondary outcomes:
measure: changes in cerebral tissue oxygenation by NIRS.
timeFrame: First hour of life for 10 minutes/ and for 2 hours on 12,24,84 hours of life
measure: ductus arteriosus diameter
timeFrame: 6, 12, 18, 24, and 48 hours of life
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams university
Study officials:
References: