NCT03731611

Brief Summary

To investigate the effect of umbilical cord milking (UCM) on peripheral hematologic parameters including hematopoietic progenitor cells in premature infants ≤ 34 weeks gestational age with placental insufficiency. We hypothesize that UCM would enhance peripheral CD34 concentration, hemoglobin and reduce prematurity complications like NEC and IVH in preterm infant ≤ 34 week gestational age with placental insufficiency.

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 Apr 2019

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

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
5 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

May 3, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

November 3, 2018

Last Update Submit

May 2, 2022

Conditions

Placental InsufficiencyPreterm Infant

Keywords

Umbilical cord milking

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 min 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 after umbilical cord milking

  • 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

ACTIVE COMPARATOR

umbilical cord milking will be done for preterm infants \<34 gestational age without placental insufficiency

Procedure: Umbilical Cord Milking

Group B

ACTIVE COMPARATOR

umbilical cord milking will be done for preterm infant \<34 gestational age with placental insufficiency

Procedure: Umbilical Cord Milking

Group C

NO INTERVENTION

Immediate cord clamping for preterm infants \<34 gestational age with placental insufficiency

Interventions

Umbilical Cord MilkingPROCEDURE

Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team.

Group AGroup B

Eligibility Criteria

Age0 Minutes+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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 (2)

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, 35111, Egypt

Location

Mansoura University Children's Hospital

Al Mansurah, Egypt

Location

Related Publications (2)

  • Li J, Yu B, Wang W, Luo D, Dai QL, Gan XQ. Does intact umbilical cord milking increase infection rates in preterm infants with premature prolonged rupture of membranes? J Matern Fetal Neonatal Med. 2020 Jan;33(2):184-190. doi: 10.1080/14767058.2018.1487947. Epub 2018 Sep 6.

    PMID: 29886779RESULT

  • Kumar B, Upadhyay A, Gothwal S, Jaiswal V, Joshi P, Dubey K. Umbilical Cord Milking and Hematological Parameters in Moderate to Late Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2015 Sep;52(9):753-7. doi: 10.1007/s13312-015-0711-1.

    PMID: 26519708RESULT

MeSH Terms

Conditions

Placental InsufficiencyPremature Birth

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Placenta DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor, PrematureObstetric Labor Complications

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
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

April 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 30, 2020

Last Updated

May 3, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)