The Effect of Cord Milking on Hemodynamic Status of Preterm Infants

Preterm Infants Clinical Trial

Official title:

The Effect of Umbilical Cord Milking on Hemodynamic Status of Preterm Infants: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01487187
• Other study ID #: 1002554
• Status: Active, not recruiting
• Phase: N/A
• First received: November 22, 2011
• Last updated: March 7, 2017
• Start date: November 2011
• Est. completion date: January 2018

Study information

• Verified date: March 2017
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 73
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 31 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

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
• immediate umbilical cord clamping
immediate cord clamping without milking as per standard practice

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Walid El-Naggar

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	low SVC flow (< 40 ml/kg/min), as assessed by echocardiography		at 4-6 and 10-12 hours of age
Secondary	Hypotension	Hypotension is defiined as mean blood pressure < corresponding gestational age number for > 30 minutes	during the first 48 hours of life
Secondary	Hyperbilirubinemia and peak bilirubin level recording	Hyperbilirubinemia requiring phototherapy (as per routine unit practice)	during first 2 weeks of age
Secondary	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
Secondary	Number of blood transfusions during hospital stay		at 40 weeks of corrected gestational age
Secondary	Intraventricular hemorrhage (IVH)	Intraventricular hemorrhage (IVH) as diagnosed by standard-practice cranial ultrasounds	during first 2 weeks of life
Secondary	Neurodevelopmental outcome		At 36 months of age