Death; Neonatal, Intraventricular Haemorrhage Neonatal
Conditions
Keywords
Premature infants, Umbilical cord milking, Delayed cord clamping, Intraventricular Hemorrhage, Death
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.
Interventions
PROCEDUREUmbilical cord milking UCM
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.
PROCEDUREDelayed cord clamping DCC
At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.
Sponsors
Sharp Mary Birch Hospital for Women & Newborns
Loma Linda University
University of Pittsburgh
Providence Hospital
University of Alabama at Birmingham
University of Alberta
University College Cork
University of Ulm
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Christiana Care Health Services
Sharp Grossmont Hospital
University of Utah
University of Mississippi Medical Center
PIH Health Good Samaritan Hospital
University of California, Irvine
Children's Hospital Medical Center, Cincinnati
Cook County Health
St. Louis University
LAC+USC Medical Center
Sharp HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
It is not possible to blind the delivering obstetrician, however all other caregivers will be blinded. The procedure will be documented as placental transfusion in the delivery summary or admission-progress notes and all study assessments whether primary (head US) or secondary (neurodevelopmental exams) will be performed by blinded team members.
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 33 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Hemoglobin/Hematocrit at 4 hours | 4 +/- 2 hours of life | hemoglobin/hematocrit |
| All Grade IVH | Through study completion at discharge, up to 6 months corrected gestational age (CGA) | Any intraventricular hemorrhage (grades 1-4) |
| 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 |
| 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 |
Countries
Canada, Germany, Ireland, United States
Outcome results
None listed