Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

Death; Neonatal Clinical Trial

— PREMOD2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019367
• Other study ID #: PREMOD2
• Secondary ID: 1R01HD088646-01A
• Status: Completed
• Phase: N/A
• Start date: June 6, 2017
• Est. completion date: September 16, 2022

Study information

• Verified date: November 2022
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1201
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 33 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Death; Neonatal
• Hemorrhage
• Intraventricular Haemorrhage Neonatal
• Premature Birth

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Governors of University of Alberta	Edmonton	Alberta
Germany	University of ULM	Ulm	Baden-Wurttemberg
Ireland	Cork University Maternity Hospital	Cork
United States	University of Alabama	Birmingham	Alabama
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Loma Linda Medical Center	Loma Linda	California
United States	LAC+USC Medical Center	Los Angeles	California
United States	PIH Health Good Samaritan Hospital	Los Angeles	California
United States	Christiana Care	Newark	Delaware
United States	University of California, Irvine Medical Center	Orange	California
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	St. Louis University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Sharp Grossmont Hospital	San Diego	California
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California

Sponsors (20)

Lead Sponsor

Collaborator

Sharp HealthCare

Children's Hospital Medical Center, Cincinnati, Christiana Care Health Services, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), John H. Stroger Hospital, LAC+USC Medical Center, Loma Linda University, PIH Health Good Samaritan Hospital, Providence Hospital, Sharp Grossmont Hospital, Sharp Mary Birch Hospital for Women & Newborns, St. Louis University, University College Cork, University of Alabama at Birmingham, University of Alberta, University of California, Irvine, University of Mississippi Medical Center, University of Pittsburgh, University of Ulm, University of Utah

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe IVH or death	Severe intraventricular hemorrhage of grade 3 or 4 or death	Through study completion at death or discharge, up to 6 months corrected gestational age (CGA)
Secondary	All Grade IVH	Any intraventricular hemorrhage (grades 1-4)	Through study completion at discharge, up to 6 months corrected gestational age (CGA)
Secondary	Severe IVH (Grade 3 or 4)	Severe intraventricular hemorrhage (bleeding in the brain parenchyma and/or ventricular dilation)	Through study completion at discharge, up to 6 months corrected gestational age (CGA)
Secondary	Hemoglobin/Hematocrit at 4 hours	hemoglobin/hematocrit	4 +/- 2 hours of life
Secondary	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	Through study completion at discharge, up to 6 months corrected gestational age (CGA)
Secondary	Delivery room interventions	Resuscitation interventions including positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications	In the first 10 minutes of life
Secondary	Blood pressures in the first 24 hours of life	Blood pressure on admission, 6, 12, 18 and 24 hours of life	In the first 24 hours of life

External Links

•   Followup Study-PREMOD2
•   NIRS Sub-study PREMOD2
•   Website for trial