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

Jaundice, Neonatal Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03741803
• Other study ID #: HSC-MS-17-0803
• Status: Suspended
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Jaundice
• Jaundice, Neonatal

Intervention

Procedure:
• Delayed cord clamping
The umbilical cord will be clamped after 60 seconds after birth
• Early cord clamping
The umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

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