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Completed

NCT Number: NCT03019367

Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

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 subsequently allowed for continuation of the trial in infants 29-32+6 wk GA.

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Key information

Conditions

Intraventricular Haemorrhage Neonatal Death Death; Neonatal Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Premature Birth Urogenital Diseases

Age range

23 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Governors of University of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 23 to 32 +6 Gestational age (currently enrolling 29 to 32+6 weeks)
  • Multiples without Twin-to-twin Transfusion Syndrome (TTTS)

Exclusion criteria

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

Treatment and study plan

Umbilical cord milking UCM

Procedure

At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before it is clamped. This procedure infuses a placental transfusion of blood into the preterm neonate and can be done in 15-20 seconds.

Delayed cord clamping DCC

Procedure

At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.

Primary outcomes

  1. Incidence of severe IVH or death

    Time frame: Through study completion at death or discharge, up to 6 months corrected gestational age (CGA)

    Severe intraventricular hemorrhage of grade 3 or 4 or death

Secondary outcomes

  1. All Grade IVH

    Time frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA)

    Any intraventricular hemorrhage (grades 1-4)

  2. Severe IVH (Grade 3 or 4)

    Time frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA)

    Severe intraventricular hemorrhage (bleeding in the brain parenchyma and/or ventricular dilation)

  3. Hemoglobin/Hematocrit at 4 hours

    Time frame: 4 +/- 2 hours of life

    hemoglobin/hematocrit

  4. Incidence of Severe IVH or death in infants <28 weeks gestation

    Time frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA)

    Severe intraventricular hemorrhage (grade 3 or 4) in infants born under 28 weeks gestational age

  5. Delivery room interventions

    Time frame: In the first 10 minutes of life

    Resuscitation interventions including positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications

  6. Blood pressures in the first 24 hours of life

    Time frame: In the first 24 hours of life

    Blood pressure on admission, 6, 12, 18 and 24 hours of life

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • Christiana Care Health Services
  • Cook County Health
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • LAC+USC Medical Center
  • Loma Linda University
  • PIH Health Good Samaritan Hospital
  • Providence Hospital
  • Sharp Grossmont Hospital
  • Sharp Mary Birch Hospital for Women & Newborns
  • St. Louis University
  • University College Cork
  • University of Alabama at Birmingham
  • University of Alberta
  • University of California, Irvine
  • University of Mississippi Medical Center
  • University of Pittsburgh
  • University of Ulm
  • University of Utah

Registry information

Official study title

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

Acronym: PREMOD2

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2017
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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