Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

King Abdulaziz University

Status: Unknown

Conditions: Intraventricular Hemorrhage; PreTerm Birth

Treatments: Other: Umbilical cord milking

Study type: Interventional

Funder types: Other

Identifiers

NCT02996799

409-16

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Deferred Cord Clamping

No Intervention group

Description:

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.

Umbilical cord milking

Experimental group

Description:

Manually stripping 20cm of cord segment toward the umbilicus over a period of 2-3 seconds three times before cord clamping.

Treatment:

Other: Umbilical cord milking