Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

• Register: ClinicalTrials.gov
• Last refreshed on: 5 December 2022
• Main ID: NCT03019367
• Date of registration: 21/11/2016
• Prospective Registration: Yes
• Primary sponsor: Sharp HealthCare
• Public title: Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2 PREMOD2
• Scientific title: Premature Infants Receiving Milking or Delayed Cord Clamping: Randomized Controlled Multicenter Non-inferiority Trial
• Date of first enrolment: June 6, 2017
• Target sample size: 1201
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03019367
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada, Germany, Ireland, United States

Contacts

• Name: Anup C Katheria, MD
• Affiliation: Sharp HealthCare

Key inclusion & exclusion criteria

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



Age minimum: 23 Weeks
Age maximum: 33 Weeks
Gender: All

Health Condition(s) or Problem(s) studied

Death; Neonatal

Intraventricular Haemorrhage Neonatal

Intervention(s)

Procedure: Umbilical cord milking UCM

Procedure: Delayed cord clamping DCC

Primary Outcome(s)

Incidence of severe IVH or death [Time Frame: Through study completion at death or discharge, up to 6 months corrected gestational age (CGA)]

Secondary Outcome(s)

Blood pressures in the first 24 hours of life [Time Frame: In the first 24 hours of life]

Severe IVH (Grade 3 or 4) [Time Frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA)]

Hemoglobin/Hematocrit at 4 hours [Time Frame: 4 +/- 2 hours of life]

All Grade IVH [Time Frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA)]

Delivery room interventions [Time Frame: In the first 10 minutes of life]

Incidence of Severe IVH or death in infants <28 weeks gestation [Time Frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA)]

Secondary ID(s)

PREMOD2

1R01HD088646-01A1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PIH Health Good Samaritan Hospital

University of Pittsburgh

Christiana Care Health Services

University College Cork

University of Utah

LAC+USC Medical Center

University of Alberta

Children's Hospital Medical Center, Cincinnati

Loma Linda University

Providence Hospital

University of California, Irvine

University of Mississippi Medical Center

Sharp Mary Birch Hospital for Women & Newborns

University of Alabama at Birmingham

University of Ulm

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

John H. Stroger Hospital

Sharp Grossmont Hospital

St. Louis University