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The Effect of Cord Milking on Hemodynamic Status of Preterm Infants

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ClinicalTrials.gov Identifier: NCT01487187
Recruitment Status : Unknown
Verified March 2017 by Walid El-Naggar, IWK Health Centre.
Recruitment status was:  Active, not recruiting
First Posted : December 7, 2011
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Walid El-Naggar, IWK Health Centre

Tracking Information
First Submitted Date  ICMJE November 22, 2011
First Posted Date  ICMJE December 7, 2011
Last Update Posted Date March 9, 2017
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth. [ Time Frame: at 4-6 hours of age ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01487187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
  • low SVC flow (< 40 ml/kg/min), as assessed by echocardiography [ Time Frame: at 4-6 and 10-12 hours of age ]
  • Hypotension [ Time Frame: during the first 48 hours of life ]
    Hypotension is defiined as mean blood pressure < corresponding gestational age number for > 30 minutes
  • Hyperbilirubinemia and peak bilirubin level recording [ Time Frame: during first 2 weeks of age ]
    Hyperbilirubinemia requiring phototherapy (as per routine unit practice)
  • Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 10-12 hours after birth. [ Time Frame: at 10-12 hours of age ]
  • Number of blood transfusions during hospital stay [ Time Frame: at 40 weeks of corrected gestational age ]
  • Intraventricular hemorrhage (IVH) [ Time Frame: during first 2 weeks of life ]
    Intraventricular hemorrhage (IVH) as diagnosed by standard-practice cranial ultrasounds
  • Neurodevelopmental outcome [ Time Frame: At 36 months of age ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Cord Milking on Hemodynamic Status of Preterm Infants
Official Title  ICMJE The Effect of Umbilical Cord Milking on Hemodynamic Status of Preterm Infants: a Randomized Controlled Trial
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)

Detailed Description Eligible mothers will be randomized prior to delivery once preterm labour is established (cervical dilatation > 4cm and preterm birth is considered inevitable or delivery is indicated for maternal or fetal indications) to either milking of the umbilical cord of their infants (intervention group) or to clamp the cord as per standard practice (currently it is the immediate cord clamping) after birth (control group). Randomization will be done in variable block sizes and will be concealed by using opaque envelopes prepared ahead of time from a randomization table. Envelopes will be opened before the time of delivery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Preterm Infants
Intervention  ICMJE
  • Procedure: Milking the umbilical cord at birth
    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
    Other Name: Transfusion of blood from umbilical cord to the baby
  • Procedure: immediate umbilical cord clamping
    immediate cord clamping without milking as per standard practice
    Other Name: standard practice-cord clamping
Study Arms  ICMJE
  • Active Comparator: immediate umbilical cord clamping
    The control group will receive immediate cord clamping at birth which is the standard of care in our institution
    Intervention: Procedure: immediate umbilical cord clamping
  • Experimental: Milking the umbilical cord at birth
    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.
    Intervention: Procedure: Milking the umbilical cord at birth
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 31, 2015)
73
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2011)
70
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:Preterm infants < 31 weeks' gestation if their mothers fulfill the following inclusion criteria:

  1. 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).
  2. at 24+0 weeks - 30+6/7 weeks gestation (by best estimate based on date of last menstrual period or early ultrasound)

Exclusion Criteria:

  1. monochorionic twin or any higher order multiple pregnancy
  2. major fetal congenital or chromosomal anomalies
  3. significant placental abruption
  4. fetal anemia/transfusion
  5. Rh isoimmunization
  6. intent to withhold or withdraw treatment of the infant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Weeks to 31 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01487187
Other Study ID Numbers  ICMJE 1002554
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Walid El-Naggar, IWK Health Centre
Study Sponsor  ICMJE Walid El-Naggar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Walid I El-Naggar, MD IWK Health Centre- Dalhousie University
PRS Account IWK Health Centre
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP