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

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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.

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.

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
Birmingham, Alabama 35294
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Edmonton, Alberta T6G 2R3
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Edmonton,
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Loma Linda, California 92354
Principal Investigator: Giang Truong, MD
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Loma Linda, CA
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Newark, Delaware 19718
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Newark, DE
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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9205 SW Barnes Rd
Portland, Oregon 97225
(503) 216-1234
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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Portland, OR
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San Diego, California 92123
Principal Investigator: Anup Katheria, MD
Phone: 858-939-4198
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San Diego, CA
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