Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice

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

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.

Study Overview

• Status: Suspended
• Conditions: Hyperbilirubinemia, Neonatal; Jaundice, Neonatal
• Intervention / Treatment: Procedure: Delayed cord clamping; Procedure: Early cord clamping

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Delayed cord clamping	Procedure: Delayed cord clamping; The umbilical cord will be clamped after 60 seconds after birth
Active Comparator: Early cord clamping	Procedure: Early cord clamping; The umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neonatal bilirubin level	24 hours after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of neonates with hyperbilirubinemia	Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood.	24 hours after birth
Number of neonates with a need for phototherapy		From birth to up to 1 week after birth
Number of neonates with a need for exchange transfusion		From birth to up to 1 week after birth
Number of neonates admitted to the neonatal intensive care unit (NICU)		From birth to up to 1 week after birth
Number of mothers with postpartum hemorrhage		From birth to up to 1 week after birth
Number of neonates re-hospitalized for jaundice		From birth to up to 1 week after birth

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Pamela D Berens, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Jaundice; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice, Neonatal
• Other Study ID Numbers: HSC-MS-17-0803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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