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Delayed Clamping and Milking the Umbilical Cord in Preterm Infants

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cord Milking
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring Premature Birth, Umbilical Cord Clamping

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Good Samaritan TriHealth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Delayed Clamping

Cord Milking

Arm Description

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

Infants randomized to the cord milking group will follow the protocol below: Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery) Infant held and the cord is milked from perineum to infant four times Assistant to deliver preps cord clamps Cord clamped and cut Infant handed off to waiting staff

Outcomes

Primary Outcome Measures

Hemoglobin and Hematocrit values (H/H) in NICU
All H/H values in the neonatal intensive care unit (NICU) will be recorded.

Secondary Outcome Measures

Neonatal transfusions
The incidence of transfusions between the two groups will be compared.
Necrotizing enterocolitis
The incidence of necrotizing enterocolitis between the two groups will be compared.
Intraventricular hemorrhage
The incidence of intraventricular hemorrhage between the two groups will be compared.

Full Information

First Posted
March 13, 2014
Last Updated
December 27, 2018
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02092103
Brief Title
Delayed Clamping and Milking the Umbilical Cord in Preterm Infants
Official Title
Delayed Clamping and Milking the Umbilical Cord Prior to Clamping in Preterm Infants and the Effect of Neonatal Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 8, 2018 (Actual)
Study Completion Date
July 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Premature Birth, Umbilical Cord Clamping

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delayed Clamping
Arm Type
No Intervention
Arm Description
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: Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery) Once infant is delivered designated RN starts timer Infant warming bag on delivery table Infant placed into warming bag then wrapped in a towel Assistant to deliver preps cord clamps Registered Nurse (RN) notifies provider at 30 seconds Cord clamped and cut Infant handed off to waiting staff Exceptions: Placental separation, cord stops pulsating, need for immediate resuscitation, all would result in clamping prior to 30 seconds
Arm Title
Cord Milking
Arm Type
Experimental
Arm Description
Infants randomized to the cord milking group will follow the protocol below: Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery) Infant held and the cord is milked from perineum to infant four times Assistant to deliver preps cord clamps Cord clamped and cut Infant handed off to waiting staff
Intervention Type
Procedure
Intervention Name(s)
Cord Milking
Intervention Description
See description in cord milking arm.
Primary Outcome Measure Information:
Title
Hemoglobin and Hematocrit values (H/H) in NICU
Description
All H/H values in the neonatal intensive care unit (NICU) will be recorded.
Time Frame
NICU admission to discharge, expected average of 50 days
Secondary Outcome Measure Information:
Title
Neonatal transfusions
Description
The incidence of transfusions between the two groups will be compared.
Time Frame
Birth to discharge, expected average of 50 days
Title
Necrotizing enterocolitis
Description
The incidence of necrotizing enterocolitis between the two groups will be compared.
Time Frame
Birth to discharge, expected average of 50 days
Title
Intraventricular hemorrhage
Description
The incidence of intraventricular hemorrhage between the two groups will be compared.
Time Frame
Birth to discharge, expected average of 50 days
Other Pre-specified Outcome Measures:
Title
Length of stay
Description
The length of NICU stay between the two arms will be compared.
Time Frame
Birth to discharge, expected average of 50 days
Title
Survival to discharge
Description
The rate of infant survival until discharge will be recorded for both groups.
Time Frame
Birth to discharge, expected average of 50 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Smith, MD PhD
Organizational Affiliation
TriHealth Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Good Samaritan TriHealth Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23168790
Citation
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.
Results Reference
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Delayed Clamping and Milking the Umbilical Cord in Preterm Infants

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