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 University of Texas Health Science Center, Houston1 site in 1 country20 target enrollmentNovember 9, 2018

ConditionsHyperbilirubinemia, Neonatal Jaundice, Neonatal

InterventionsDelayed cord clamping Early cord clamping

Overview

Phase: N/A
Intervention: Delayed cord clamping
Conditions: Hyperbilirubinemia, Neonatal
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 20
Locations: 1
Primary Endpoint: Neonatal bilirubin level
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 9, 2018

End Date

May 27, 2019

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Pamela Berens

Professor

The University of Texas Health Science Center, Houston

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).

Arms & Interventions

Delayed cord clamping

Intervention: Delayed cord clamping

Early cord clamping

Intervention: Early cord clamping

Outcomes

Primary Outcomes

Neonatal bilirubin level

Time Frame: 24 hours after birth

Secondary Outcomes

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 re-hospitalized for jaundice(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 neonates with hyperbilirubinemia(24 hours after birth)
Number of mothers with postpartum hemorrhage(From birth to up to 1 week after birth)