Delayed Clamping and Milking the Umbilical Cord in Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by TriHealth Inc.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT02092103
First received: March 13, 2014
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

This is a randomized controlled trial that will compare the effects of delayed umbilical cord clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). The infants' hemoglobin and hematocrit levels in the Neonatal Intensive Care Unit (NICU) will be evaluated, as well as the rates of necrotizing enterocolitis, intraventricular hemorrhage, and blood transfusions. The hypothesis is that milking the umbilical cord prior to clamping is superior to simply delayed cord clamping, presumably providing an increased blood volume to the preterm neonate improving its outcomes.


Condition Intervention
Premature Birth
Infant, Extremely Premature
Infant, Premature
Procedure: Cord Milking

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Delayed Clamping and Milking the Umbilical Cord Prior to Clamping in Preterm Infants and the Effect of Neonatal Outcomes

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • Hemoglobin and Hematocrit values (H/H) in NICU [ Time Frame: NICU admission to discharge, expected average of 50 days ] [ Designated as safety issue: No ]
    All H/H values in the neonatal intensive care unit (NICU) will be recorded.


Secondary Outcome Measures:
  • Neonatal transfusions [ Time Frame: Birth to discharge, expected average of 50 days ] [ Designated as safety issue: No ]
    The incidence of transfusions between the two groups will be compared.

  • Necrotizing enterocolitis [ Time Frame: Birth to discharge, expected average of 50 days ] [ Designated as safety issue: No ]
    The incidence of necrotizing enterocolitis between the two groups will be compared.

  • Intraventricular hemorrhage [ Time Frame: Birth to discharge, expected average of 50 days ] [ Designated as safety issue: No ]
    The incidence of intraventricular hemorrhage between the two groups will be compared.


Other Outcome Measures:
  • Length of stay [ Time Frame: Birth to discharge, expected average of 50 days ] [ Designated as safety issue: No ]
    The length of NICU stay between the two arms will be compared.

  • Survival to discharge [ Time Frame: Birth to discharge, expected average of 50 days ] [ Designated as safety issue: No ]
    The rate of infant survival until discharge will be recorded for both groups.


Estimated Enrollment: 240
Study Start Date: March 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Delayed Clamping

The American Congress of Obstetricians and Gynecologists (ACOG) recommends delayed cord clamping for preterm infants. Infants randomized to this group will follow the protocol below:

  1. Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery)
  2. Once infant is delivered designated RN starts timer
  3. Infant warming bag on delivery table
  4. Infant placed into warming bag then wrapped in a towel
  5. Assistant to deliver preps cord clamps
  6. Registered Nurse (RN) notifies provider at 30 seconds
  7. Cord clamped and cut
  8. Infant handed off to waiting staff
  9. Exceptions: Placental separation, cord stops pulsating, need for immediate resuscitation, all would result in clamping prior to 30 seconds
Experimental: Cord Milking

Infants randomized to the cord milking group will follow the protocol below:

  1. Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery)
  2. Infant held and the cord is milked from perineum to infant four times
  3. Assistant to deliver preps cord clamps
  4. Cord clamped and cut
  5. Infant handed off to waiting staff
Procedure: Cord Milking
See description in cord milking arm.

Detailed Description:

The optimal timing for clamping the umbilical cord after birth in preterm infants has been a subject of controversy and debate for many years. It has been until recently the standard practice in ob/gyn to clamp the umbilical cord immediately post delivery to allow for immediate transition resuscitation of the neonate, especially in preterm infants. Due to the fact that optimal timing for cord clamping has yet to be definitively established in the preterm population, more information is needed. Immediate cord clamping, however, could preclude the infant from an extra boost in blood volume that may prove beneficial later in the newborn life. Directly comparing the recently recommended practice of delayed umbilical cord clamping to milking the umbilical cord prior to clamping has the potential to prove beneficial for the neonates in question, as well as change daily obstetrical practices. In this study all infants below 34 weeks will be randomized into one of two groups: delayed cord clamping and milking the umbilical cord prior to clamping. The decision was made not to include immediate cord clamping due to a recent American Congress of Obsetricians and Gynecologists (ACOG) recommendation that all preterm infants have their cord clamping be delayed. Their outcomes will be measured by serial hemoglobin and hematocrit levels while in the NICU, the incidence of necrotizing enterocolitis, incidence of intraventricular hemorrhage, and the need for neonatal blood transfusions.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to Labor & Delivery at Good Samaritan TriHealth Hospital in Cincinnati, Ohio with expected/possible preterm delivery between 23-34 weeks gestation
  • Care provided by Good Samaritan TriHealth Hospital's Faculty Medical Center or Tri-State Maternal Fetal Medicine

Exclusion Criteria:

  • Declined to participate
  • Known congenital anomalies
  • Precipitous delivery preventing completion of the protocol
  • Placental abruption around the time of or as indication for delivery
  • Mother has uterine rupture
  • Non reassuring fetal heart tracing (FHT) immediately prior/leading to delivery
  • Multiple gestation
  • Parvo B19
  • Infants known to be at risk of anemia due to isoimmunization (mother has red blood cell antibodies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02092103

Contacts
Contact: Kathleen Smith, MD PhD 513-862-6200 kate_smith@trihealth.com
Contact: Stephanie Manolis, DO 513-819-1374 stephanie_manolis@trihealth.com

Locations
United States, Ohio
Good Samaritan TriHealth Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Michaela Eschenbacher, MPH    513-862-2341    michaela_eschenbacher@trihealth.com   
Sponsors and Collaborators
TriHealth Inc.
Investigators
Principal Investigator: Kathleen Smith, MD PhD TriHealth Inc.
  More Information

Publications:
Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02092103     History of Changes
Other Study ID Numbers: 13094-14-012
Study First Received: March 13, 2014
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
Premature Birth
Umbilical Cord Clamping

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on August 28, 2014