The Effect of Cord Milking on Hemodynamic Status of Preterm Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preterm Infants

Intervention / Treatment
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* Procedure: Milking the umbilical cord at birth
* Procedure: immediate umbilical cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Preterm infants < 31 weeks' gestation if their mothers fulfill the following inclusion criteria: 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). at 24+0 weeks - 30+6/7 weeks gestation (by best estimate based on date of last menstrual period or early ultrasound) Exclusion Criteria: monochorionic twin or any higher order multiple pregnancy major fetal congenital or chromosomal anomalies significant placental abruption fetal anemia/transfusion Rh isoimmunization intent to withhold or withdraw treatment of the infant

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 31 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: immediate umbilical cord clamping<br>The control group will receive immediate cord clamping at birth which is the standard of care in our institution | Procedure: immediate umbilical cord clamping<br>* immediate cord clamping without milking as per standard practice<br>* Other names: standard practice-cord clamping;|
| Experimental: Milking the umbilical cord at birth<br>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<br>* 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<br>* Other names: Transfusion of blood from umbilical cord to the baby;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cord-milking, hemodynamic, preterm infants