NCT03731546

Brief Summary

To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age or less) with placental insufficiency.We hypothesized that preterm infants with placental insufficiency underwent DDC could have better hematologic parameters and hematopoietic progenitor cells compared to immediate cord clamping.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

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

September 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

November 3, 2018

Last Update Submit

May 15, 2022

Conditions

Preterm InfantPlacental InsufficiencyPlacental Transfusion

Keywords

Delayed cord clampingPreterm InfantPlacental InsufficiencyIntrauterine growth restriction

Outcome Measures

Primary Outcomes (1)

  • Peripheral venous CD34 at admission

    One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 minutes of life and CD34 will be assessed by flow cytometry.

    first 24 hours of infants' life

Secondary Outcomes (16)

  • Admission hemoglobin

    first 24 hours of infants' life

  • Hemoglobin at 2 months

    2 months of infants' life

  • Admission platelets

    first 24 hours of infants' life

  • Admission WBCs

    first 24 hours of infants' life

  • Phototherapy requirements

    first 28 days of life

  • +11 more secondary outcomes

Study Arms (3)

Group A

NO INTERVENTION

Placental insufficiency and ICC : Immediate cord clamping after delivery of the fetus in preterm infants with placental insufficiency

Group B

ACTIVE COMPARATOR

Placental insufficiency and DCC: Cord clamping 60 seconds after delivery of fetus in preterm infants with placental insufficiency

Procedure: Delayed cord clamping

Group C

ACTIVE COMPARATOR

Normal placenta with DCC:Cord clamping 60 seconds after delivery of fetus in preterm infants without placental insufficiency

Procedure: Delayed cord clamping

Interventions

Delayed cord clampingPROCEDURE

Cord clamping 60 seconds after delivery of fetus in preterm infants

Group BGroup C

Eligibility Criteria

Age0 Minutes - 1 Minute
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • preterm neonates \< 34 weeks gestational age

You may not qualify if:

  • Vaginal bleeding due to placental abruption or tears Multiple pregnancies Suspected major fetal anomalies Suspected chromosomal aberration Maternal drug abuse Hydrops fetalis preterm who needed major resuscitative measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Children's Hospital

Al Mansurah, Egypt

Location

Related Publications (3)

  • Gokmen Z, Ozkiraz S, Tarcan A, Kozanoglu I, Ozcimen EE, Ozbek N. Effects of delayed umbilical cord clamping on peripheral blood hematopoietic stem cells in premature neonates. J Perinat Med. 2011 May;39(3):323-9. doi: 10.1515/jpm.2011.021. Epub 2011 Mar 11.

    PMID: 21391876BACKGROUND

  • Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.

    PMID: 23168790BACKGROUND

  • Yunis M, Nour I, Gibreel A, Darwish M, Sarhan M, Shouman B, Nasef N. Effect of delayed cord clamping on stem cell transfusion and hematological parameters in preterm infants with placental insufficiency: a pilot randomized trial. Eur J Pediatr. 2021 Jan;180(1):157-166. doi: 10.1007/s00431-020-03730-4. Epub 2020 Jul 4.

    PMID: 32623628DERIVED

MeSH Terms

Conditions

Premature BirthPlacental InsufficiencyFetofetal TransfusionFetal Growth Retardation

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta DiseasesAnemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFetal DiseasesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of pediatrics/Neonatology

Study Record Dates

First Submitted

November 3, 2018

First Posted

November 6, 2018

Study Start

September 1, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)