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Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2 (PREMOD2)

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ClinicalTrials.gov Identifier: NCT03019367
Recruitment Status : Active, not recruiting
First Posted : January 12, 2017
Last Update Posted : October 8, 2018
Sponsor:
Collaborators:
Sharp Mary Birch Hospital for Women & Newborns
Loma Linda University
University of Pittsburgh
Providence Hospital
University of Alabama at Birmingham
University of Alberta
University College Cork
University of Ulm
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Christiana Care Health Services
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare

November 21, 2016
January 12, 2017
October 8, 2018
June 6, 2017
September 17, 2018   (Final data collection date for primary outcome measure)
Incidence of severe IVH or death [ Time Frame: Through study completion at death or discharge, up to 6 months corrected gestational age (CGA) ]
Severe intraventricular hemorrhage of grade 3 or 4 or death
Incidence of severe IVH or death [ Time Frame: Through study completion at death or discharge, up to 6 months corrected gestational age (CGA) ]
Complete list of historical versions of study NCT03019367 on ClinicalTrials.gov Archive Site
  • All Grade IVH [ Time Frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA) ]
    Any intraventricular hemorrhage (grades 1-4)
  • Severe IVH (Grade 3 or 4) [ Time Frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA) ]
    Severe intraventricular hemorrhage (bleeding in the brain parenchyma and/or ventricular dilation)
  • Hemoglobin/Hematocrit at 4 hours [ Time Frame: 4 +/- 2 hours of life ]
    hemoglobin/hematocrit
  • 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) ]
    Severe intraventricular hemorrhage (grade 3 or 4) in infants born under 28 weeks gestational age
  • Delivery room interventions [ Time Frame: In the first 10 minutes of life ]
    Resuscitation interventions including positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications
  • Blood pressures in the first 24 hours of life [ Time Frame: In the first 24 hours of life ]
    Blood pressure on admission, 6, 12, 18 and 24 hours of life
  • Incidence of death or neurodevelopmental impairment at 22-26 months corrected gestational age [ Time Frame: Through follow up completion at 26 months corrected gestational age ]
  • All Grade Intraventricular Hemorrhage [ Time Frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA) ]
  • 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 ]
  • 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) ]
  • Cerebral StO2 during Resuscitation [ Time Frame: In the first 10 minutes of life ]
  • Cerebral StO2 in the NICU [ Time Frame: In the first 72 hours of life ]
Not Provided
Not Provided
 
Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
Premature Infants Receiving Milking or Delayed Cord Clamping: Randomized Controlled Multicenter Non-inferiority Trial
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.

Aim 1. Compare the incidence of severe intraventricular hemorrhage (IVH) and/or death in premature newborns <32 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 <32 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 <32 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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:
It is not possible to blind the delivering obstetrician, however all other caregivers will be blinded. The procedure will be documented as "placental transfusion" in the delivery summary or admission-progress notes and all study assessments whether primary (head US) or secondary (neurodevelopmental exams) will be performed by blinded team members.
Primary Purpose: Prevention
  • Intraventricular Haemorrhage Neonatal
  • Death; Neonatal
  • 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.
  • Active Comparator: Umbilical cord milking UCM
    Milking the umbilical cord 4 times towards the infant at a speed of 20cm/2seconds.
    Intervention: Procedure: Umbilical cord milking UCM
  • Active Comparator: Delayed cord clamping DCC
    Delayed clamping of the umbilical cord for at least 60 seconds.
    Intervention: Procedure: Delayed cord clamping DCC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
470
1500
December 2020
September 17, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 23 to 31 +6 Gestational age
  • Multiples unless monochorionic

Exclusion Criteria:

  • Congenital anomalies
  • Major cardiac defects
  • Placental abruption or previa with hemorrhage
  • Cord prolapse
  • Hydrops
  • Bleeding Accreta
  • Monochorionic multiples (i.e. Di/Mo or Mo/Mo twins)
  • Fetal or maternal risk (i.e. compromise)
  • Parents declined study
  • Unlikely to return for 2 yr Follow Up
Sexes Eligible for Study: All
23 Weeks to 32 Weeks   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Ireland,   United States
 
 
NCT03019367
PREMOD2
1R01HD088646-01A1 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Data will be made available per NICHD requirements (National Institute of Child Health and Human Development).
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 2 years after primary publication
Access Criteria: An archived dataset with documentation will be made available for additional uses by outside investigators, in collaboration with the study investigators. We will work with NICHD program staff to develop a broad data sharing plan over time.
Anup Katheria, M.D., Sharp HealthCare
Sharp HealthCare
  • Sharp Mary Birch Hospital for Women & Newborns
  • Loma Linda University
  • University of Pittsburgh
  • Providence Hospital
  • University of Alabama at Birmingham
  • University of Alberta
  • University College Cork
  • University of Ulm
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Christiana Care Health Services
Principal Investigator: Anup C Katheria, MD Sharp HealthCare
Sharp HealthCare
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP