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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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ClinicalTrials.gov Identifier: NCT03741803
Recruitment Status : Not yet recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Pamela Berens, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Hyperbilirubinemia, Neonatal Jaundice, Neonatal Device: Delayed cord clamping Device: Early cord clamping Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : November 5, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Arm Intervention/treatment
Active Comparator: Delayed cord clamping Device: Delayed cord clamping
The umbilical cord will be clamped after 60 seconds after birth

Active Comparator: Early cord clamping Device: Early cord clamping
The umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth.




Primary Outcome Measures :
  1. Neonatal bilirubin level [ Time Frame: 24 hours after birth ]

Secondary Outcome Measures :
  1. Number of neonates with hyperbilirubinemia [ Time Frame: 24 hours after birth ]
    Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood.

  2. Number of neonates with a need for phototherapy [ Time Frame: From birth to up to 1 week after birth ]
  3. Number of neonates with a need for exchange transfusion [ Time Frame: From birth to up to 1 week after birth ]
  4. Number of neonates admitted to the neonatal intensive care unit (NICU) [ Time Frame: From birth to up to 1 week after birth ]
  5. Number of mothers with postpartum hemorrhage [ Time Frame: From birth to up to 1 week after birth ]
  6. Number of neonates re-hospitalized for jaundice [ Time Frame: From birth to up to 1 week after birth ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741803


Contacts
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Contact: Pamela D Berens, MD (713) 500-6471 Pamela.D.Berens@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Pamela D Berens, MD    713-500-6471    Pamela.D.Berens@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Pamela D Berens, MD The University of Texas Health Science Center, Houston

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Responsible Party: Pamela Berens, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03741803     History of Changes
Other Study ID Numbers: HSC-MS-17-0803
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Jaundice
Hyperbilirubinemia
Jaundice, Neonatal
Hyperbilirubinemia, Neonatal
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Infant, Newborn, Diseases
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs