Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm (CORDMILK-PT)

Nemours Children's Health

Status: Enrolling

Conditions: Infant Death; Preterm

Treatments: Procedure: Umbilical cord milking

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06240715

CORDMILK-PT

Details and patient eligibility

About

The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.

Full description

Background: Prematurity is the leading cause of death in children younger than 5 years of age. Worldwide, 15 million infants are born premature, and India alone contributes to quarter of them. Approximately 1 million children die each year due to complications of prematurity.

Delayed cord clamping (DCC), one of the methods of transfer of placental blood to neonates (placental transfusion) immediately after birth reduce mortality by 30% in premature infants. But DCC is not recommended in neonates who require immediate resuscitation. Umbilical cord milking (UCM) is an option for placental transfusion in preterm infants who require immediate resuscitation but not currently recommended due to lack of randomized clinical trials.

HYPOTHESIS: UCM will reduce the in-hospital mortality in non-vigorous preterm infants born between 30 weeks to 34 weeks of gestation compared to early cord clamping.

METHODS: This multicenter cluster crossover randomized trial will enroll approximately 800 preterm infants to early cord clamping or milking the intact cord 4 times prior to clamping.

IMPACT: If investigators find that UCM is beneficial, this simple, low-tech, no cost intervention can be used in preventing deaths in preterm infants. This trial will potentially provide evidence to support a change in guidelines making UCM part of standard practice worldwide for preterm infants who require immediate resuscitation.

Enrollment: 800 estimated patients

Sex: All

Ages: Under 10 minutes old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
• Non-vigorous at birth

Exclusion criteria

• Infants with congenital malformation
• Major chromosomal abnormalities
• Complete placental abruption/cutting through the placenta at the time of delivery
• Cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord)
• Mono-chorionic twins,
• Twins with no information on amnion/chorion
• Multiple gestation >2

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

800 participants in 2 patient groups

Umbilical Cord Milking

Active Comparator group

Description:

The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for early cord clamping (ECC).

Treatment:

Procedure: Umbilical cord milking

Early Cord Clamping

No Intervention group

Description:

Umbilical cord will be clamped immediately after birth (within 60 seconds)