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Completed

NCT Number: NCT05922488

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

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

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Key information

Conditions

Ductus Arteriosus Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ainshams university

Cairo, 11517, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Umbilical Cord Milking

Procedure

Umbilical cord milking : uncut umbilical cord and squeeze it from the placenta several times toward the infant usually within 20 seconds.

Delayed Cord Clamping

Procedure

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

Primary outcomes

  1. time of functional ductus arteriosus closure

    Time frame: 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 outcomes

  1. changes in cerebral tissue oxygenation by NIRS.

    Time frame: 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.

  2. ductus arteriosus diameter

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2023
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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