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

June 19, 2023 updated by: walaa M Madkoor, MD [walaa madkoor], Ain Shams University

Effect of Umbilical Cord Milking Versus Delayed Clamping in Preterm Infants 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11517
        • Ainshams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
Procedure: delayed cord clamping
delayed cord clamping: delivery the delivering obstetrician will wait at least 60 s before clamping the umbilical cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6, 12, 18, 24, and 48 hours of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First hour of life for 10 minutes/ and for 2 hours on 12,24,84 hours of life
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
6, 12, 18, 24, and 48 hours of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

April 20, 2023

Study Completion (Actual)

April 20, 2023

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M D 75 / 2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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