Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

Study Overview
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Brief Summary
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For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.

Detailed Description
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Contrary to delayed cord clamping, milking of the umbilical cord is done at a faster rate and in shorter time.Recent evidence has demonstrated the efficacy and safety of umbilical cord milking for both term and preterm infants.A newer evidence comparing delayed cord clamping to umbilical cord milking in preterm infants demonstrated a higher initial hemoglobin, blood pressure and systemic blood flow in preterm infants allocated to the umbilical cord milking arm.However, concerns have been raised with regard to rapid infusion of large volume of blood in relatively shorter time predisposing to hyperperfusion injury including intraventricular hemorrhage. This is particularly problematic for preterm neonates as they are at higher risk of neurological injury. It has, though, advantage of shorter timeframe allowing for effective resuscitation of preterm neonates to start as soon as possible. Thus, with countering advantages and disadvantages, the practice has not been adopted at most places. The authors planned to conduct a randomized clinical trail to compare the efficacy and safety of umbilical cord milking to deferred cord clamping in preterm infants less than 32 weeks gestation.

Official Title
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Efficacy and Safety of Deferred Umbilical Cord Clamping Compared to Umbilical CordMilking in Preterm Infants: A Randomized Clinical Trial

Conditions
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PreTerm Birth, Intraventricular Hemorrhage

Intervention / Treatment
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* Other: Umbilical cord milking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants < 32 weeks gestation confirmed by first trimester US Exclusion Criteria: Any proven or suspected congenital or chromosomal abnormalities Placenta previa or abruption Cord prolapse Known Rh sensitization Fetal hydrops Monochorionic multiples
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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Deferred Cord Clamping<br>Neonate is held at the level of placenta (level of introitus (vaginal delivery ) and mother's thigh or operating table (C/S) and cord clamping is deferred for 60 seconds. | |
| Experimental: Umbilical cord milking<br>Manually stripping 20cm of cord segment toward the umbilicus over a period of 2-3 seconds three times before cord clamping. | Other: Umbilical cord milking<br>* Milking of the umbilical cord at delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraventricular haemorrhage | Any IVH diagnosed by cranial ultrasound | twenty eight days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for resuscitation | Cardiac compression or medications at birth | one hour | 
| Apgar score at one minute | Calculated Apgar score at one minute | one minute after delivery | 
| Apgar score at 5 minutes | Calculated Apgar score at 5 minutes | 5 minutes after delivery | 
| The need for blood transfusion during hospital stay | The number of blood transfusions during hospital stay | one month | 
| Venous Hgb | Hgb at birth | 2 days | 
| Venous hematocrit | Hematocrit at birth | 2 days | 
| Bilirubin level | First bilirubin level after birth | 24 hours after birth | 
| Maximum bilirubin level | Highest bilirubin level | first week of life | 
| Polycythemia | If venous hematocrit more than 65% | first 48 hours after birth | 
| Respiratory distress syndrome | The need for surfactant administration | 48 hours after birth | 
| Oxygen dependency | first 28 days after birth and/or 36 weeks corrected age | first 28 days after birth and 36 weeks corrected age | 
| Need for volume administration | Need for bolus administration first 24 hours after birth | 24 hours after birth | 
| Use of inotropes | Use of any kind of inotropes in the first 24 hours | First 24 hours | 
| Necrotizing enterocolitis | Bell stage II or more | one month | 
| Mortality in hospital | Death before discharge | one month | 
| Sepsis | Positive blood culture | one month | 
| Maternal mortality | Maternal death after delivery in hospital | 2 weeks | 
| Post partum hemorrhage | Maternal estimated blood loss more than 500 mls in the first 24 hours after birth | one day | 
| Maternal need for blood transfusion | Maternal blood transfusion in the first 48 hours after delivery | First 48 hours after delivery | 
| Length of third stage | The time from delivery of the infant until delivery of placenta | 24 hours |