NCT01487187

Brief Summary

Very preterm babies frequently develop problems with their blood circulation during the first few days after birth. These circulation problems could affect the oxygen and blood flow to their brain and lead to effects such as bleeding in the head or delayed developmental milestones later in life. Currently the care for such problems may include transfusion of intravenous fluids or blood to the baby and/or giving the baby medications that can help circulation. The current practice at the delivery of these babies is to immediately clamp their umbilical cords after birth. Recent research studies have shown that giving more of the baby's own blood to them at birth by delayed cord clamping (waiting for clamping the cord for about 30-90 seconds) or by milking the cord, may reduce the number of blood transfusions that these babies may need later on. It may also improve their initial blood pressure and reduce the chances of bleeding in their heads. More research is needed to prove if either delayed cord clamping or milking the cord at birth will be better in terms of improving these babies' health. The aim of this study is to find out if adding some blood to these babies' circulation, through milking the cord at birth, could prevent or reduce the possible problems with blood circulation and the reduced blood flow to the brain that some of these babies may have after birth. The investigators will also investigate if milking the cord at birth could improve their long-term developmental outcome. Hypothesis: In preterm infants less than 31 weeks' gestation, milking the umbilical cord 3 times prior to clamping, compared to immediate clamping after birth will improve systemic blood flow (as assessed by improving superior vena cava flow measured by heart ultrasound in the first 24 hours after birth)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

6.2 years

First QC Date

November 22, 2011

Last Update Submit

March 7, 2017

Conditions

Preterm Infants

Keywords

Cord-milkinghemodynamicpreterm infants

Outcome Measures

Primary Outcomes (1)

  • Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth.

    at 4-6 hours of age

Secondary Outcomes (7)

  • low SVC flow (< 40 ml/kg/min), as assessed by echocardiography

    at 4-6 and 10-12 hours of age

  • Hypotension

    during the first 48 hours of life

  • Hyperbilirubinemia and peak bilirubin level recording

    during first 2 weeks of age

  • Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 10-12 hours after birth.

    at 10-12 hours of age

  • Number of blood transfusions during hospital stay

    at 40 weeks of corrected gestational age

  • +2 more secondary outcomes

Study Arms (2)

immediate umbilical cord clamping

ACTIVE COMPARATOR

The control group will receive immediate cord clamping at birth which is the standard of care in our institution

Procedure: immediate umbilical cord clamping

Milking the umbilical cord at birth

EXPERIMENTAL

Infants in the cord-milked group will be placed at or below the level of the placenta, and about 20 cm of the umbilical cord (or the length of cord that is accessible if less than 20 cm) will be vigorously milked towards the umbilicus three times before clamping the cord.

Procedure: Milking the umbilical cord at birth

Interventions

Milking the umbilical cord at birthPROCEDURE

Infants in the cord-milked group will be placed at or below the level of the placenta, and about 20 cm of the umbilical cord (or the length of cord that is accessible if less than 20 cm) will be vigorously milked towards the umbilicus three times before clamping the cord

Also known as: Transfusion of blood from umbilical cord to the baby
Milking the umbilical cord at birth
immediate umbilical cord clampingPROCEDURE

immediate cord clamping without milking as per standard practice

Also known as: standard practice-cord clamping
immediate umbilical cord clamping

Eligibility Criteria

Age24 Weeks - 31 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • admitted to the hospital for at least 2 hours before delivery in preterm labor (cervical dilatation \>2 cm or having premature rupture of membranes) or if a decision to induce labour has been made by treating physician for a maternal or fetal indications).
  • at 24+0 weeks - 30+6/7 weeks gestation (by best estimate based on date of last menstrual period or early ultrasound)

You may not qualify if:

  • monochorionic twin or any higher order multiple pregnancy
  • major fetal congenital or chromosomal anomalies
  • significant placental abruption
  • fetal anemia/transfusion
  • Rh isoimmunization
  • intent to withhold or withdraw treatment of the infant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, Canada

Location

Related Publications (3)

  • El-Naggar W, McMillan D, Hussain A, Armson A, Dodds L, Warren A, Whyte R, Vincer M, Simpson CD. Neurodevelopmental outcomes of very preterm infants who received cord milking at birth: a randomized controlled trial. Eur J Pediatr. 2022 Dec;181(12):4215-4220. doi: 10.1007/s00431-022-04638-x. Epub 2022 Oct 4.

    PMID: 36194256DERIVED

  • El-Naggar W, McMillan D, Hussain A, Armson A, Warren A, Whyte R, Simpson D. The effect of umbilical cord milking on cerebral blood flow in very preterm infants: a randomized controlled study. J Perinatol. 2021 Feb;41(2):263-268. doi: 10.1038/s41372-020-00780-2. Epub 2020 Aug 11.

    PMID: 32782323DERIVED

  • El-Naggar W, Simpson D, Hussain A, Armson A, Dodds L, Warren A, Whyte R, McMillan D. Cord milking versus immediate clamping in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2019 Mar;104(2):F145-F150. doi: 10.1136/archdischild-2018-314757. Epub 2018 Jun 14.

    PMID: 29903720DERIVED

MeSH Terms

Interventions

Umbilical Cord Clamping

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Walid I El-Naggar, MD

    IWK Health Centre- Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

November 22, 2011

First Posted

December 7, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Locations

CA(1)