NCT05922488

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

1.4 years

First QC Date

April 26, 2023

Last Update Submit

June 19, 2023

Conditions

Ductus Arteriosus

Keywords

Cerebral tissue oxygenationFunctional Ductus arteriosus closureUmbilical cord milkingDelayed cord clamping

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • changes in cerebral tissue oxygenation by NIRS.

    First hour of life for 10 minutes/ and for 2 hours on 12,24,84 hours of life

  • ductus arteriosus diameter

    6, 12, 18, 24, and 48 hours of life

Study Arms (2)

Umbilical cord milking

EXPERIMENTAL

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

delayed cord clamping

EXPERIMENTAL

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

Interventions

Umbilical cord milkingPROCEDURE

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

Umbilical cord milking
delayed cord clampingPROCEDURE

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

delayed cord clamping

Eligibility Criteria

AgeUp to 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainshams university

Cairo, 11517, Egypt

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
all involved neonates will be randomized to DCC or UCM according to the randomization table and double-blinded method.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: all involved neonates will be randomized to DCC or UCM according to the randomization table and double-blinded method.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant fellow of pediatrics at Ahmed Maher teaching hospital

Study Record Dates

First Submitted

April 26, 2023

First Posted

June 28, 2023

Study Start

December 1, 2021

Primary Completion

April 20, 2023

Study Completion

April 20, 2023

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)