Back to resultsRelationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
Primary Purpose
Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delayed cord clamping
Early cord clamping
Sponsored by
About this trial
This is an interventional prevention trial for Hyperbilirubinemia, Neonatal
Eligibility Criteria
Inclusion Criteria:
- mothers delivering at 35 weeks or greater
- mothers who have had at least 1 previous child that received phototherapy for hyperbilirubinemia
- multiple gestations can be included unless the neonate does not meet criteria for delayed cord clamping as described below or due to concerns about safety of delayed cord clamping for timing of delivery of the 2nd twin (ie: 2nd twin requires immediate delivery intervention)
Exclusion Criteria:
- Neonates who do not meet criteria for delayed cord clamping (any infant that any provider in the room felt needed evaluation by the neonatal transport team immediately so that the infant would be handed off for resuscitation. If the patient required delivery by cesarean section the delayed cord clamping protocol would be abandoned).
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Delayed cord clamping
Early cord clamping
Arm Description
Outcomes
Primary Outcome Measures
Neonatal bilirubin level
Secondary Outcome Measures
Number of neonates with hyperbilirubinemia
Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood.
Number of neonates with a need for phototherapy
Number of neonates with a need for exchange transfusion
Number of neonates admitted to the neonatal intensive care unit (NICU)
Number of mothers with postpartum hemorrhage
Number of neonates re-hospitalized for jaundice
Full Information
NCT ID
NCT03741803
First Posted
November 12, 2018
Last Updated
January 31, 2022
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03741803
Brief Title
Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
Official Title
Randomized Controlled Trial to Evaluate the Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Suspended
Why Stopped
Study paused due to COVID-19 and personnel
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of the study is to determine if neonates (who already have an increased risk of hyperbilirubinemia due to mother's history of having previous neonate who received phototherapy for hyperbilirubinemia) have higher bilirubin levels 24 hours after birth with delayed cord clamping.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Delayed cord clamping
Arm Type
Active Comparator
Arm Title
Early cord clamping
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Delayed cord clamping
Intervention Description
The umbilical cord will be clamped after 60 seconds after birth
Intervention Type
Procedure
Intervention Name(s)
Early cord clamping
Intervention Description
The umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth.
Primary Outcome Measure Information:
Title
Neonatal bilirubin level
Time Frame
24 hours after birth
Secondary Outcome Measure Information:
Title
Number of neonates with hyperbilirubinemia
Description
Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood.
Time Frame
24 hours after birth
Title
Number of neonates with a need for phototherapy
Time Frame
From birth to up to 1 week after birth
Title
Number of neonates with a need for exchange transfusion
Time Frame
From birth to up to 1 week after birth
Title
Number of neonates admitted to the neonatal intensive care unit (NICU)
Time Frame
From birth to up to 1 week after birth
Title
Number of mothers with postpartum hemorrhage
Time Frame
From birth to up to 1 week after birth
Title
Number of neonates re-hospitalized for jaundice
Time Frame
From birth to up to 1 week after birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mothers delivering at 35 weeks or greater
mothers who have had at least 1 previous child that received phototherapy for hyperbilirubinemia
multiple gestations can be included unless the neonate does not meet criteria for delayed cord clamping as described below or due to concerns about safety of delayed cord clamping for timing of delivery of the 2nd twin (ie: 2nd twin requires immediate delivery intervention)
Exclusion Criteria:
- Neonates who do not meet criteria for delayed cord clamping (any infant that any provider in the room felt needed evaluation by the neonatal transport team immediately so that the infant would be handed off for resuscitation. If the patient required delivery by cesarean section the delayed cord clamping protocol would be abandoned).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela D Berens, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
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