Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Women's Studies |
| Therapuetic Areas: | Neurology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/6/2019 |
| Start Date: | June 6, 2017 |
| End Date: | December 2024 |
| Contact: | Anup C Katheria, MD |
| Email: | anup.katheria@sharp.com |
| Phone: | 858 939-4170 |
Premature Infants Receiving Milking or Delayed Cord Clamping: Randomized Controlled Multicenter Non-inferiority Trial
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 consequently allowed
for continuation of the trial in infants 30-32+6 wk GA.
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 consequently allowed
for continuation of the trial in infants 30-32+6 wk GA.
Aim 1. Compare the incidence of severe intraventricular hemorrhage (IVH) and/or death in
premature newborns 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 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 by C/S (Cesarean section) (from Aims 1 and 2) with those born by V/D (vaginal delivery)
receiving UCM or DCC.
premature newborns 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 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 by C/S (Cesarean section) (from Aims 1 and 2) with those born by V/D (vaginal delivery)
receiving UCM or DCC.
Inclusion Criteria:
- 23 to 32 +6 Gestational age
- Multiples unless monochorionic
Exclusion Criteria:
- Congenital anomalies
- Major cardiac defects
- Placental abruption or previa with hemorrhage
- Cord prolapse
- Hydrops
- Bleeding Accreta
- Monochorionic multiples (i.e. Di/Mo or Mo/Mo twins)
- Fetal or maternal risk (i.e. compromise)
- Parents declined study
- Unlikely to return for 2 yr Follow Up
We found this trial at
7
sites
San Diego, California 92123
Principal Investigator: Anup Katheria, MD
Phone: 858-939-4198
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