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Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks

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Johns Hopkins University

Status

Terminated

Conditions

Prematurity

Treatments

Procedure: Milking group
Procedure: Immediate cord clamping

Study type

Interventional

Funder types

Other

Identifiers

NCT01819532
NA_00046760

Details and patient eligibility

About

Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.

Enrollment

22 patients

Sex

Female

Ages

15 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Preterm neonates delivered between 24 0/7 and 32 6/7
  • Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age
  • Written parental consent

Exclusion criteria

  • Multiple gestation pregnancies (twins or higher order multiples)
  • Rh or other antibody sensitization
  • Hydrops fetalis
  • Known major congenital abnormality
  • Suspected abruptio placentae

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

22 participants in 2 patient groups

Immediate umbilical cord clamping
Active Comparator group
Description:
The umbilical cord will be clamped immediately after delivery.
Treatment:
Procedure: Immediate cord clamping
Cord milking group
Experimental group
Description:
The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes.
Treatment:
Procedure: Milking group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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