Delayed Clamping and Milking the Umbilical Cord in Preterm Infants
1 other identifier
interventional
282
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 13, 2014
CompletedFirst Posted
Study publicly available on registry
March 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2018
CompletedDecember 28, 2018
September 1, 2018
4.4 years
March 13, 2014
December 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin and Hematocrit values (H/H) in NICU
All H/H values in the neonatal intensive care unit (NICU) will be recorded.
NICU admission to discharge, expected average of 50 days
Secondary Outcomes (3)
Neonatal transfusions
Birth to discharge, expected average of 50 days
Necrotizing enterocolitis
Birth to discharge, expected average of 50 days
Intraventricular hemorrhage
Birth to discharge, expected average of 50 days
Other Outcomes (2)
Length of stay
Birth to discharge, expected average of 50 days
Survival to discharge
Birth to discharge, expected average of 50 days
Study Arms (2)
Delayed Clamping
NO INTERVENTIONThe 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
Cord Milking
EXPERIMENTALInfants 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TriHealth Inc.lead
Study Sites (1)
Good Samaritan TriHealth Hospital
Cincinnati, Ohio, 45220, United States
Related Publications (1)
Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.
PMID: 23168790BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen Smith, MD PhD
TriHealth Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2014
First Posted
March 19, 2014
Study Start
March 1, 2014
Primary Completion
July 8, 2018
Study Completion
July 8, 2018
Last Updated
December 28, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share