Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2 (PREMOD2)
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|ClinicalTrials.gov Identifier: NCT03019367|
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : October 15, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Intraventricular Haemorrhage Neonatal Death; Neonatal||Procedure: Umbilical cord milking UCM Procedure: Delayed cord clamping DCC||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, 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.|
|Official Title:||Premature Infants Receiving Milking or Delayed Cord Clamping: Randomized Controlled Multicenter Non-inferiority Trial|
|Actual Study Start Date :||June 6, 2017|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 2024|
Active Comparator: Umbilical cord milking UCM
Milking the umbilical cord 4 times towards the infant at a speed of 20cm/2seconds.
Procedure: Umbilical 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.
Active Comparator: Delayed cord clamping DCC
Delayed clamping of the umbilical cord for at least 60 seconds.
Procedure: Delayed 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.
- 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
- All Grade IVH [ Time Frame: 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) [ 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)
- Hemoglobin/Hematocrit at 4 hours [ Time Frame: 4 +/- 2 hours of life ]hemoglobin/hematocrit
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019367
|Contact: Anup C Katheria, MD||858 firstname.lastname@example.org|
|Contact: Kathy M Arnell, RN||858 email@example.com|
|Principal Investigator:||Anup C Katheria, MD||Sharp HealthCare|