NCT03019367

Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

Premature Infants Receiving Milking or Delayed Cord Clamping: Randomized Controlled Multicenter Non-inferiority Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,201 (actual)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 23 Weeks – 33 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Intraventricular Haemorrhage Neonatal
• Death; Neonatal

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2017-06-06
• Primary completion: 2022-09-16
• Completion: 2022-09-16
• First posted: 2017-01-12
• Last updated: 2022-11-23

Locations

18 sites across 4 countries: United States, Canada, Germany, Ireland