The Effect of Cord Milking on Hemodynamic Status of Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by IWK Health Centre
Sponsor:
Information provided by (Responsible Party):
Walid El-Naggar, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01487187
First received: November 22, 2011
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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)


Condition Intervention Phase
Preterm Infants
Procedure: Milking the umbilical cord at birth
Procedure: immediate umbilical cord clamping
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Umbilical Cord Milking on Hemodynamic Status of Preterm Infants: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • low SVC flow (< 40 ml/kg/min), as assessed by echocardiography [ Time Frame: at 4-6 and 10-12 hours of age ] [ Designated as safety issue: No ]
  • Hypotension [ Time Frame: during the first 48 hours of life ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Number of blood transfusions during hospital stay [ Time Frame: at 40 weeks of corrected gestational age ] [ Designated as safety issue: No ]
  • Intraventricular hemorrhage (IVH) [ Time Frame: during first 2 weeks of life ] [ Designated as safety issue: No ]
    Intraventricular hemorrhage (IVH) as diagnosed by standard-practice cranial ultrasounds

  • Neurodevelopmental outcome [ Time Frame: At 36 months of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: November 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: immediate umbilical cord clamping
immediate cord clamping without milking as per standard practice
Other Name: standard practice-cord clamping
Experimental: milking of 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.
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

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.

  Eligibility

Ages Eligible for Study:   24 Weeks to 31 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487187

Contacts
Contact: Walid I El-Naggar, MD 902-470-7961

Locations
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada
Principal Investigator: Walid I El-Naggar, MD         
Sponsors and Collaborators
Walid El-Naggar
Investigators
Principal Investigator: Walid I El-Naggar, MD IWK Health Centre- Dalhousie University
  More Information

No publications provided

Responsible Party: Walid El-Naggar, Primary Investigator, IWK Health Centre
ClinicalTrials.gov Identifier: NCT01487187     History of Changes
Other Study ID Numbers: 1002554
Study First Received: November 22, 2011
Last Updated: September 24, 2014
Health Authority: Canada: Health Canada

Keywords provided by IWK Health Centre:
Cord-milking
hemodynamic
preterm infants

ClinicalTrials.gov processed this record on October 22, 2014