RecruitingNot ApplicableNCT06240715

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

A Cluster Randomized Clinical Trial of Umbilical Cord Milking Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth


Sponsor

Nemours Children's Clinic

Enrollment

800 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 0 MinutesMax Age: 10 Minutes

Inclusion Criteria2

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

Exclusion Criteria7

  • 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

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Interventions

PROCEDUREUmbilical 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.


Locations(9)

KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College

Belagavi, Karnataka, India

Government Medical College

Chandrapur, Maharashtra, India

Indira Gandhi Government Medical College & Hospital

Nagpur, Maharashtra, India

Yashwantrao Chavan Memorial Hospital

Pune, Maharashtra, India

Daga Memorial Woman and Children Hospital

Nagpur, MS, India

Government Medical College and Hospital

Nagpur, MS, India

Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital

Wardha, MS, India

Sawai Man Singh Medical College

Jaipur, Rajasthan, India

Osmania Medical College, Niloufer Hospital

Hyderabad, Telangana, India

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NCT06240715


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