Summary

Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

This study is being done to find out whether umbilical cord milking (UCM) is at least as good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent death in premature newborns. The investigators will study short and long term outcomes of infants delivered before 32 weeks gestation that receive either UCM or DCC. * The trial was stopped by the DSMB for safety in the small strata. They consequently allowed for continuation of the trial in infants 29-32+6 wk GA.

Official Title

Premature Infants Receiving Milking or Delayed Cord Clamping: Randomized Controlled Multicenter Non-inferiority Trial

Details

Aim 1. Compare the incidence of severe intraventricular hemorrhage (IVH) and/or death in premature newborns </=33 weeks gestational age (GA) delivered by C/S receiving UCM to those receiving DCC.

Hypothesis1: First demonstrate infants in the UCM group are not inferior to the DCC group (reject H10).

Hypothesis2: If H1 is true, demonstrate lower incidence of severe IVH and/or death in UCM infants compared to DCC.

Aim 2. Compare the safety and efficacy profiles of premature newborns </=33 weeks GA delivered by C/S receiving UCM vs. DCC during their hospitalization.

Hypothesis3: UCM group will have a decreased need for resuscitation interventions with no differences in bilirubin or polycythemia compared to DCC.

Hypothesis4: UCM group will have improved blood pressures in the first 24 hours of life compared to DCC.

Aim 3 (exploratory). To compare the outcomes of premature newborns </=33 weeks GA delivered by C/S (Cesarean section) (from Aims 1 and 2) with those born by V/D (vaginal delivery) receiving UCM or DCC.

Keywords

Intraventricular Haemorrhage Neonatal Death; Neonatal Premature infants Umbilical cord milking Delayed cord clamping Intraventricular Hemorrhage Death Premature Birth Hemorrhage Umbilical cord milking UCM Delayed cord clamping DCC

Eligibility

You can join if…

  • 23 to 32 +6 Gestational age (currently enrolling 29 to 32+6 weeks)
  • Multiples unless monochorionic

You CAN'T join if...

  • Congenital anomalies
  • Major cardiac defects
  • Placental abruption or previa with hemorrhage
  • Cord prolapse
  • Hydrops
  • Bleeding Accreta
  • Monochorionic multiples (i.e. Di/Mo or Mo/Mo twins)
  • Fetal or maternal risk (i.e. compromise)
  • Parents declined study
  • Unlikely to return for 2 yr Follow Up

Locations

  • University of California, Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • PIH Health Good Samaritan Hospital accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sharp HealthCare
Links
Website for trial
ID
NCT03019367
Study Type
Interventional
Last Updated