NCT01487187

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Walid El-Naggar · Academic / Other
• Sex: All
• Age: 24 Weeks – 31 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Infants

Interventions

Type	Name	Description
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
PROCEDURE	immediate umbilical cord clamping	immediate cord clamping without milking as per standard practice

Timeline

• Start date: 2011-11-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2011-12-07
• Last updated: 2017-03-09

Locations

1 site across 1 country: Canada