Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
- Conditions
- Death; NeonatalIntraventricular Haemorrhage Neonatal
- Interventions
- Procedure: Delayed cord clamping DCCProcedure: Umbilical cord milking UCM
- Registration Number
- NCT03019367
- Lead Sponsor
- Sharp HealthCare
- Brief 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 subsequently allowed for continuation of the trial in infants 29-32+6 wk GA.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1201
- 23 to 32 +6 Gestational age (currently enrolling 29 to 32+6 weeks)
- Multiples without Twin-to-twin Transfusion Syndrome (TTTS)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed cord clamping DCC Delayed cord clamping DCC Delayed clamping of the umbilical cord for at least 60 seconds. Umbilical cord milking UCM Umbilical cord milking UCM Milking the umbilical cord 4 times towards the infant at a speed of 20cm/2seconds.
- Primary Outcome Measures
Name Time Method Incidence of severe IVH or death 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 Outcome Measures
Name Time Method All Grade IVH Through study completion at discharge, up to 6 months corrected gestational age (CGA) Any intraventricular hemorrhage (grades 1-4)
Severe IVH (Grade 3 or 4) 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)
Delivery room interventions In the first 10 minutes of life Resuscitation interventions including positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications
Hemoglobin/Hematocrit at 4 hours 4 +/- 2 hours of life hemoglobin/hematocrit
Blood pressures in the first 24 hours of life In the first 24 hours of life Blood pressure on admission, 6, 12, 18 and 24 hours of life
Incidence of Severe IVH or death in infants <28 weeks gestation 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
Trial Locations
- Locations (18)
John H. Stroger, Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Loma Linda Medical Center
🇺🇸Loma Linda, California, United States
LAC+USC Medical Center
🇺🇸Los Angeles, California, United States
Governors of University of Alberta
🇨🇦Edmonton, Alberta, Canada
Christiana Care
🇺🇸Newark, Delaware, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
PIH Health Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
Sharp Grossmont Hospital
🇺🇸San Diego, California, United States
Sharp Mary Birch Hospital for Women and Newborns
🇺🇸San Diego, California, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Cork University Maternity Hospital
🇮🇪Cork, Ireland
University of ULM
🇩🇪Ulm, Baden-Wurttemberg, Germany