Delayed Clamping and Milking the Umbilical Cord in Preterm Infants

Premature Birth Clinical Trial

Official title:

Delayed Clamping and Milking the Umbilical Cord Prior to Clamping in Preterm Infants and the Effect of Neonatal Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092103
• Other study ID #: 13094-14-012
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: July 8, 2018

Study information

• Verified date: September 2018
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Obstetricians 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: July 8, 2018
• Est. primary completion date: July 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Procedure:
• Cord Milking
See description in cord milking arm.

Locations

Country	Name	City	State
United States	Good Samaritan TriHealth Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay	The length of NICU stay between the two arms will be compared.	Birth to discharge, expected average of 50 days
Other	Survival to discharge	The rate of infant survival until discharge will be recorded for both groups.	Birth to discharge, expected average of 50 days
Primary	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	Neonatal transfusions	The incidence of transfusions between the two groups will be compared.	Birth to discharge, expected average of 50 days
Secondary	Necrotizing enterocolitis	The incidence of necrotizing enterocolitis between the two groups will be compared.	Birth to discharge, expected average of 50 days
Secondary	Intraventricular hemorrhage	The incidence of intraventricular hemorrhage between the two groups will be compared.	Birth to discharge, expected average of 50 days