Premature Infants Receiving Milking or Delayed Cord Clamping: Randomized Controlled Multicenter Non-inferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intraventricular Haemorrhage Neonatal
- Sponsor
- Sharp HealthCare
- Enrollment
- 1201
- Locations
- 18
- Primary Endpoint
- Incidence of severe IVH or death
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Anup Katheria, M.D.
Director of Neonatal Research Institute
Sharp HealthCare
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
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
- All Grade IVH(Through study completion at discharge, up to 6 months corrected gestational age (CGA))
- Severe IVH (Grade 3 or 4)(Through study completion at discharge, up to 6 months corrected gestational age (CGA))
- Delivery room interventions(In the first 10 minutes of life)
- Hemoglobin/Hematocrit at 4 hours(4 +/- 2 hours of life)
- Blood pressures in the first 24 hours of life(In the first 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))