Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

N/ACompletedNCT03019367

Sharp HealthCare1,201 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,201

Conditions

Intraventricular Haemorrhage Neonatal Death; Neonatal

Interventions

Umbilical cord milking UCMPROCEDURE

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.

Delayed cord clamping DCCPROCEDURE

At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.

Eligibility

Sex: ALLMin age: 23 WeeksMax age: 33 Weeks

Medical Language ↔ Plain English

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

Locations (18)

University of Alabama

Birmingham, Alabama, United States

Loma Linda Medical Center

Loma Linda, California, United States

Outcomes

Primary Outcomes

Incidence of severe IVH or death

Severe intraventricular hemorrhage of grade 3 or 4 or death

Time frame: Through study completion at death or discharge, up to 6 months corrected gestational age (CGA)

Secondary Outcomes

All Grade IVH

Any intraventricular hemorrhage (grades 1-4)

Time frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA)

Severe IVH (Grade 3 or 4)

Severe intraventricular hemorrhage (bleeding in the brain parenchyma and/or ventricular dilation)

Time frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA)

Hemoglobin/Hematocrit at 4 hours

hemoglobin/hematocrit

Time frame: 4 +/- 2 hours of life

Incidence of Severe IVH or death in infants <28 weeks gestation

Severe intraventricular hemorrhage (grade 3 or 4) in infants born under 28 weeks gestational age

Time frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA)

Delivery room interventions

Resuscitation interventions including positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications

Time frame: In the first 10 minutes of life

Blood pressures in the first 24 hours of life

Blood pressure on admission, 6, 12, 18 and 24 hours of life

Time frame: In the first 24 hours of life

Data from ClinicalTrials.gov

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