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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
180
Milking of the umbilical cord at delivery
King Abdulaziz University Hospital
Jeddah, Saudi Arabia
RECRUITINGIntraventricular haemorrhage
Any IVH diagnosed by cranial ultrasound
Time frame: twenty eight days
Need for resuscitation
Cardiac compression or medications at birth
Time frame: one hour
Apgar score at one minute
Calculated Apgar score at one minute
Time frame: one minute after delivery
Apgar score at 5 minutes
Calculated Apgar score at 5 minutes
Time frame: 5 minutes after delivery
The need for blood transfusion during hospital stay
The number of blood transfusions during hospital stay
Time frame: one month
Venous Hgb
Hgb at birth
Time frame: 2 days
Venous hematocrit
Hematocrit at birth
Time frame: 2 days
Bilirubin level
First bilirubin level after birth
Time frame: 24 hours after birth
Maximum bilirubin level
Highest bilirubin level
Time frame: first week of life
Polycythemia
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If venous hematocrit more than 65%
Time frame: first 48 hours after birth
Respiratory distress syndrome
The need for surfactant administration
Time frame: 48 hours after birth
Oxygen dependency
first 28 days after birth and/or 36 weeks corrected age
Time frame: first 28 days after birth and 36 weeks corrected age
Need for volume administration
Need for bolus administration first 24 hours after birth
Time frame: 24 hours after birth
Use of inotropes
Use of any kind of inotropes in the first 24 hours
Time frame: First 24 hours
Necrotizing enterocolitis
Bell stage II or more
Time frame: one month
Mortality in hospital
Death before discharge
Time frame: one month
Sepsis
Positive blood culture
Time frame: one month
Maternal mortality
Maternal death after delivery in hospital
Time frame: 2 weeks
Post partum hemorrhage
Maternal estimated blood loss more than 500 mls in the first 24 hours after birth
Time frame: one day
Maternal need for blood transfusion
Maternal blood transfusion in the first 48 hours after delivery
Time frame: First 48 hours after delivery
Length of third stage
The time from delivery of the infant until delivery of placenta
Time frame: 24 hours