Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

Sharp HealthCare

Status: Completed

Conditions: Intraventricular Haemorrhage Neonatal; Death; Neonatal

Treatments: Procedure: Umbilical cord milking UCM; Procedure: Delayed cord clamping DCC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03019367

PREMOD2

1R01HD088646-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,201 patients

Sex: All

Ages: 23 to 33 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,201 participants in 2 patient groups

Umbilical cord milking UCM

Active Comparator group

Description:

Milking the umbilical cord 4 times towards the infant at a speed of 20cm/2seconds.

Treatment:

Procedure: Umbilical cord milking UCM

Delayed cord clamping DCC

Active Comparator group

Description:

Delayed clamping of the umbilical cord for at least 60 seconds.

Treatment:

Procedure: Delayed cord clamping DCC