Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preterm Infant Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cluster Randomized Crossover

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Umbilical Cord Milking

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).

Group Type ACTIVE_COMPARATOR

Umbilical cord milking

Intervention Type PROCEDURE

At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 1--15 seconds.

Early Cord Clamping

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Umbilical cord milking

At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 1--15 seconds.

Intervention Type PROCEDURE

Other Intervention Names

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UCM

Eligibility Criteria

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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

Minimum Eligible Age

0 Minutes

Maximum Eligible Age

10 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Zubair Aghai

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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