The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates.

Study Overview
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Brief Summary
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Comparing the beneficial effect of cord milking versus deferred cord clamping in preterm neonates. A randomized controlled trial

Detailed Description
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Placental transfusion either by deferred cord clamping or umbilical cord milking became standard care and recommended management especially in preterm deliveries.1 In average, about 80 ml of blood was found to be transferred to the neoborn by one minute after birth.2 This additional blood can afford extra iron and blood volume giving the benefit of less iron deficiency anemia during the first year of life, less need for blood transfusion, less need for vasopressors and less intraventricular hemorrhage (IVH) by 50%.3 Placental transfusion with different techniques proved safety with no significant risks regarding postpartum hemorrhage, polycythemia, jaundice, Apgar score or admission rates.4 Our study aims to compare delayed cord clamping with umbilical cord milking as the best way for placental transfusion for preterm neonates.

Official Title
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The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates. A Randomized Controlled Trial

Conditions
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Delayed Cord Clamping, Umbilical Cord Milking, Preterm Neonates

Intervention / Treatment
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* Procedure: delayed cord clamping
* Procedure: cord milking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Gestational age 24 to 34+6 weeks Exclusion Criteria: Category III CTG Monochorionic twins Significant antepartum hemorrhage IUGR or Rh incompatibility

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: delayed cord clamping<br>Keep the baby at the level or below the placenta for 45-60 seconds before clamping the cord. Keep the room temperature at 23-25˚C and wrap the baby if possible | Procedure: delayed cord clamping<br>* delay of cord clamping for 60 seconds<br>|
| Active Comparator: cord milking<br>Do 4-5 strips from proximal (maternal) end of the cord (as proximal as possible) towards the baby abdomen with thumb and forefinger Wait for 2 seconds between each stripping Keep the baby at the level of placenta | Procedure: cord milking<br>* active cord milking 5 times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematological parameters of the premature neonates | first draw and peak hematocrit value and hemoglobin percent, need for inotropes and blood transfusion | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite neonatal morbidities | incidence of intraventricular hemorrhage, necrotizing enterocolitis, retinopathy, jaundice, sepsis , patent ductus arteriosus, etc | 12 month |