Hyperbilirubinemia, NeonatalNCT03741803
Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
A study testing Delayed cord clamping and Early cord clamping in people with Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- What is being tested?
- Delayed cord clamping and Early cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 27 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
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.
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- Being tested
- Delayed cord clamping, Early cord clamping
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed cord clampingProcedure or surgery
The umbilical cord will be clamped after 60 seconds after birth
Early cord clampingProcedure or surgery
The umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth.
| Study group | Role | What they receive |
|---|---|---|
| Delayed cord clamping | Active comparator | Not described Receives: Procedure: Delayed cord clamping |
| Early cord clamping | Active comparator | Not described Receives: Procedure: Early cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal bilirubin level
Measured: 24 hours after birth
Secondary outcomes (6)
Number of neonates with hyperbilirubinemia
Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood.
Measured: 24 hours after birth
Number of neonates with a need for phototherapy
Measured: From birth to up to 1 week after birth
Number of neonates with a need for exchange transfusion
Measured: From birth to up to 1 week after birth
Number of neonates admitted to the neonatal intensive care unit (NICU)
Measured: From birth to up to 1 week after birth
Number of mothers with postpartum hemorrhage
Measured: From birth to up to 1 week after birth
Number of neonates re-hospitalized for jaundice
Measured: From birth to up to 1 week after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start9 Nov 2018
- Primary completion27 May 2019
- Study completion27 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Berens, The University of Texas Health Science Center, Houston
- Investigators
- Pamela D Berens, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741803
- Sponsor's protocol ID
- HSC-MS-17-0803
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2018
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03741803
- Acronym / sponsor ID
- HSC-MS-17-0803
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 27 May 2019 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed cord clamping | Active comparator | Procedure: Delayed cord clamping |
| Early cord clamping | Active comparator | Procedure: Early cord clamping |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed cord clampingThe umbilical cord will be clamped after 60 seconds after birth | Procedure or surgery | Delayed cord clamping |
| Early cord clampingThe umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth. | Procedure or surgery | Early cord clamping |
Primary outcome
Neonatal bilirubin level
Time frame: 24 hours after birth
6 secondary outcomes
Number of neonates with hyperbilirubinemia
Time frame: 24 hours after birth
Number of neonates with a need for phototherapy
Time frame: From birth to up to 1 week after birth
Number of neonates with a need for exchange transfusion
Time frame: From birth to up to 1 week after birth
Number of neonates admitted to the neonatal intensive care unit (NICU)
Time frame: From birth to up to 1 week after birth
Number of mothers with postpartum hemorrhage
Time frame: From birth to up to 1 week after birth
Number of neonates re-hospitalized for jaundice
Time frame: From birth to up to 1 week after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela D Berens, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed cord clamping and Early cord clamping in people with Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal bilirubin level (time frame: 24 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.