The Effect of Cord Milking on Hemodynamic Status of Preterm Infants

This study is currently recruiting participants.
Verified December 2011 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: December 5, 2011
Last verified: December 2011

November 22, 2011
December 5, 2011
November 2011
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01487187 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Cord Milking on Hemodynamic Status of Preterm Infants
The Effect of Umbilical Cord Milking on Hemodynamic Status of Preterm Infants: a Randomized Controlled Trial

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)

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Preterm Infants
  • 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
  • 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 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.
    Intervention: Procedure: Milking the umbilical cord at birth
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2016
December 2013   (final data collection date for primary outcome measure)

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
Both
24 Weeks to 31 Weeks
No
Contact: Walid I El-Naggar, MD 902-470-7961
Canada
 
NCT01487187
1002554
Yes
Walid El-Naggar, IWK Health Centre
Walid El-Naggar
Not Provided
Principal Investigator: Walid I El-Naggar, MD IWK Health Centre- Dalhousie University
IWK Health Centre
December 2011

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