Neonatal JaundicePREVENTNCT06341582
Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort
An observational study of Neonatal Jaundice and Neonatal Hyperbilirubinemia, run by Guangzhou Women and Children's Medical Center at 7 sites in China.
Trial summary
The hemolytic disease of newborns (HDN) is one of the most significant risk factors for hyperbilirubinemia. Studies have shown that end-tidal carbon monoxide-corrected (ETCOc) correlated with the rate of bilirubin production in the body and thus can be a good surrogate to quantify hemolysis and identifying the… Read more about this study
- Who is it for?
- Ages 1 hour to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Neonatal Jaundice, Neonatal Hyperbilirubinemia, Hemolysis Neonatal
- What is being tested?
- End-tidal carbon monoxide-corrected (ETCOc)
- How many people
- 2,700 participants
- Where
- 7 sitesChina
- Study dates
- 11 Dec 2023to Nov 2025
- How long will I take part?
- 28 Days
- Phase
- Observational
- 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 1 hour to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: The eligible study population will be screened in the well-baby nursery or the neonatal intensive care unit (NICU).
Who may be able to join
- Infants who are born at gestational age ≥35 weeks and with a birth weight ≥2000 grams within 72 hours after birth
- Infants who are born at study centers
- Infants with the informed consent obtained from the parents or legal guardians
Who cannot join
- Immediate requirement of respiratory support after birth (e.g., mechanical ventilation, nasal high-flow cannula oxygen therapy)
- Mothers who have active tobacco smoking or continuous environmental tobacco exposure during pregnancy
- Major congenital anomalies (e.g., cardiac or lung abnormalities, lethal chromosomal defects)
- The presence of injury of nasal mucosa, choanal atresia or Pierre Robin Sequence
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Dongguan Maternity and Child Healthcare Hospital
Dongguan, Guangdong, 523700
Minxu Li, M.D.
- Not yet recruiting
Foshan Shunde Women and Children Health Care Hospital
Foshan, Guangdong, 528300
Runzhong Huang, M.D.
- Not yet recruiting
Guangdong Maternity and Child Healthcare Hospital
Guangzhou, Guangdong, 510010
Chuan Nie, M.D.
- Not yet recruiting
The First affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Muxue Yu, M.D.
- Recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
Ge Yang, M.D., (86)020-38076329, geyang99@outlook.com
Huayan Zhang, M.D.
- Not yet recruiting
The First Affiliated Hospital of Jinan University, Guangzhou Overseas Chinese Hospital
Guangzhou, Guangdong, 510632
Bingxiao Li, M.D.
Shasha Han, M.D.
- Not yet recruiting
Shenzhen Maternity and Child Healthcare Hospital
Shenzhen, Guangdong, 518000
Chuanzhong Yang, M.D.
About this study
Official title: Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia (PREVENT) Cohort: a Multi-center Prospective Cohort Study
The hemolytic disease of newborns (HDN) is one of the most significant risk factors for hyperbilirubinemia. Studies have shown that end-tidal carbon monoxide-corrected (ETCOc) correlated with the rate of bilirubin production in the body and thus can be a good surrogate to quantify hemolysis and identifying the high-risk infants. However, there is insufficient clinical evidence regarding the early prediction of hemolytic hyperbilirubinemia using ETCOc. This study hypothesizes that early postnatal ETCOc levels are significantly associated with the risk of hemolytic hyperbilirubinemia requiring treatments within 14 days after birth, and early postnatal ETCOc can be a good indicator for early prediction of hemolysis. In addition, the investigators aim to investigate the relationship between the characteristics of treatments for hyperbilirubinemia and ETCOc.
Read the detailed description
Study design: this study is a multi-center, prospective observational cohort study on neonatal jaundice. Eligible participants will be enrolled in the well-baby nursery and neonatal intensive care units (NICU). Transcutaneous bilirubin and/or total serum bilirubin (TCB/TSB) will be measured as per clinical practice and simultaneous ETCOc (within time intervals ≤3 hours) will be monitored until (1) the newborn is discharged with the mother, or (2) until 72 hours after birth or (3) requiring the treatments for hyperbilirubinemia (phototherapy and/or exchange transfusion) (whichever comes first). For infants who do not require treatments for hyperbilirubinemia (phototherapy and/or exchange transfusion) during the stay in well-baby nursery or in the NICU within 72 hours after birth, they will be followed up via telephone or outpatient clinic visits during the first 14 days of life (DOL).
The primary outcome is the first occurrence of hemolytic hyperbilirubinemia requiring treatments within DOL14. For participants who have the primary outcome occurred within DOL14, follow-up calls/visits will continue until DOL28 to record the readmissions due to hyperbilirubinemia within 28 DOL . The secondary outcomes are 1) the incidence of hemolytic diseases of newborns; 2) characteristics of treatment for hemolytic hyperbilirubinemia: postnatal age when requiring the treatment, levels of TCB/TSB/ETCOc during hospitalization, length of stay, length of phototherapy, courses of phototherapy, exchange of transfusion, the use of intravenous immunoglobulin; 3) characteristics of readmission for hyperbilirubinemia in 28 DOL: readmission for hyperbilirubinemia in 28 DOL, postnatal age when readmitted, TCB/TSB levels when readmitted
Exposures and measurements:
- Early postnatal (≤72 hours) ETCOc levels
- ETCOc levels within 14 days after birth
- ETCOc levels before each phototherapy and/or exchange transfusion treatment
- ETCOc levels when stopping phototherapy and/or exchange transfusion treatment
Covariates and characteristics: covariates will be collected including maternal and prenatal history (e.g., mother's blood type [ABO and Rh type], G6PD deficiency status, etc.), family history (e.g., history of hemolytic diseases in the previous newborn, history of NHB treatment in the previous newborn, etc.). Clinical characteristics include demographic characteristics (e.g., gestational age, birth weight), infant's blood type (ABO and Rh type), the status of G6PD deficiency,ABO incompatibility and hemolysis, feeding history and other risk factors (e.g., early discharge after birth, excessive weight loss and the presence of hematoma) as well as data related to the primary and secondary outcomes.
For analysis, this study will examine the association between early postnatal ETCOc and the incidence of hemolytic hyperbilirubinemia, and the relation of ETCOc levels with the characteristics of treatments for hyperbilirubinemia.
- Being tested
- End-tidal carbon monoxide-corrected (ETCOc)
- Keywords
- Neonatal Hyperbilirubinemia, Hemolysis Neonatal, End-tidal carbon monoxide-corrected (ETCOc)
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-tidal carbon monoxide-corrected (ETCOc)Diagnostic test
Early postnatal ETCOc levels
| Study group | Role | What they receive |
|---|---|---|
| Neonates with hemolytic hyperbilirubinemia | Neonates who are diagnosed as neonatal hyperbilirubinemia and hemolytic diseases of newborns.
Neonatal hyperbilirubinemia is defined as the total serum bilirubin (TSB) reaching or exceeding the thresholds in aligned with the 2004 American Academy of Pediatrics (AAP) guidelines.
Hemolytic diseases of newborns is defined as a diagnosis of ABO hemolytic diseases of newborns and/or glucose-6-phosphate dehydrogenase (G6PD) deficiency. Receives: Diagnostic Test: End-tidal carbon monoxide-corrected (ETCOc) | |
| Neonates without hemolytic hyperbilirubinemia | Neonates who have no neonatal hyperbilirubinemia. Receives: Diagnostic Test: End-tidal carbon monoxide-corrected (ETCOc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hemolytic hyperbilirubinemia within 14 days of life (DOL)
The incidence of neonatal hyperbilirubinemia and hemolytic diseases of newborns
Measured: Within 14 days of life (DOL)
Secondary outcomes (2)
The incidence of neonatal hyperbilirubinemia within 14 days of life (DOL)
The diagnosis of neonatal hyperbilirubinemia as per the 2004 AAP guidelines
Measured: Within 14 days of life (DOL)
The incidence of hemolytic diseases of newborns within 14 days of life (DOL)
The diagnosis of ABO hemolytic diseases of newborns and/or G6PD deficiency
Measured: Within 14 days of life (DOL)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start11 Dec 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,700 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huayan Zhang, M.D., Guangzhou Women and Children's Medical Center
- Investigators
- Huayan Zhang, M.D., Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341582
- Sponsor's protocol ID
- 2023-10-14
- Acronym
- PREVENT
- Status last verified
- Mar 2024
- First submitted
- 24 Dec 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia (PREVENT) Cohort: a Multi-center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06341582
- Acronym / sponsor ID
- PREVENT / 2023-10-14
- Keywords
- Neonatal Hyperbilirubinemia, Hemolysis Neonatal, End-tidal carbon monoxide-corrected (ETCOc)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 2 Apr 2024 (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 hemolytic disease of newborns (HDN) is one of the most significant risk factors for hyperbilirubinemia. Studies have shown that end-tidal carbon monoxide-corrected (ETCOc) correlated with the rate of bilirubin production in the body and thus can be a good surrogate to quantify hemolysis and identifying the high-risk infants. However, there is insufficient clinical evidence regarding the early prediction of hemolytic hyperbilirubinemia using ETCOc. This study hypothesizes that early postnatal ETCOc levels are significantly associated with the risk of hemolytic hyperbilirubinemia requiring treatments within 14 days after birth, and early postnatal ETCOc can be a good indicator for early prediction of hemolysis. In addition, the investigators aim to investigate the relationship between the characteristics of treatments for hyperbilirubinemia and ETCOc.
Detailed description
Study design: this study is a multi-center, prospective observational cohort study on neonatal jaundice. Eligible participants will be enrolled in the well-baby nursery and neonatal intensive care units (NICU). Transcutaneous bilirubin and/or total serum bilirubin (TCB/TSB) will be measured as per clinical practice and simultaneous ETCOc (within time intervals ≤3 hours) will be monitored until (1) the newborn is discharged with the mother, or (2) until 72 hours after birth or (3) requiring the treatments for hyperbilirubinemia (phototherapy and/or exchange transfusion) (whichever comes first). For infants who do not require treatments for hyperbilirubinemia (phototherapy and/or exchange transfusion) during the stay in well-baby nursery or in the NICU within 72 hours after birth, they will be followed up via telephone or outpatient clinic visits during the first 14 days of life (DOL).
The primary outcome is the first occurrence of hemolytic hyperbilirubinemia requiring treatments within DOL14. For participants who have the primary outcome occurred within DOL14, follow-up calls/visits will continue until DOL28 to record the readmissions due to hyperbilirubinemia within 28 DOL . The secondary outcomes are 1) the incidence of hemolytic diseases of newborns; 2) characteristics of treatment for hemolytic hyperbilirubinemia: postnatal age when requiring the treatment, levels of TCB/TSB/ETCOc during hospitalization, length of stay, length of phototherapy, courses of phototherapy, exchange of transfusion, the use of intravenous immunoglobulin; 3) characteristics of readmission for hyperbilirubinemia in 28 DOL: readmission for hyperbilirubinemia in 28 DOL, postnatal age when readmitted, TCB/TSB levels when readmitted
Exposures and measurements:
- Early postnatal (≤72 hours) ETCOc levels
- ETCOc levels within 14 days after birth
- ETCOc levels before each phototherapy and/or exchange transfusion treatment
- ETCOc levels when stopping phototherapy and/or exchange transfusion treatment
Covariates and characteristics: covariates will be collected including maternal and prenatal history (e.g., mother's blood type [ABO and Rh type], G6PD deficiency status, etc.), family history (e.g., history of hemolytic diseases in the previous newborn, history of NHB treatment in the previous newborn, etc.). Clinical characteristics include demographic characteristics (e.g., gestational age, birth weight), infant's blood type (ABO and Rh type), the status of G6PD deficiency,ABO incompatibility and hemolysis, feeding history and other risk factors (e.g., early discharge after birth, excessive weight loss and the presence of hematoma) as well as data related to the primary and secondary outcomes.
For analysis, this study will examine the association between early postnatal ETCOc and the incidence of hemolytic hyperbilirubinemia, and the relation of ETCOc levels with the characteristics of treatments for hyperbilirubinemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonates with hemolytic hyperbilirubinemia | – | Diagnostic Test: End-tidal carbon monoxide-corrected (ETCOc)Neonates who are diagnosed as neonatal hyperbilirubinemia and hemolytic diseases of newborns. Neonatal hyperbilirubinemia is defined as the total serum bilirubin (TSB) reaching or exceeding the thresholds in aligned with the 2004 American Academy of Pediatrics (AAP) guidelines. Hemolytic diseases of newborns is defined as a diagnosis of ABO hemolytic diseases of newborns and/or glucose-6-phosphate dehydrogenase (G6PD) deficiency. |
| Neonates without hemolytic hyperbilirubinemia | – | Diagnostic Test: End-tidal carbon monoxide-corrected (ETCOc)Neonates who have no neonatal hyperbilirubinemia. |
Who may qualify
- Ages
- 1 hour to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The eligible study population will be screened in the well-baby nursery or the neonatal intensive care unit (NICU).
Key inclusion criteria (3 listed)
- Infants who are born at gestational age ≥35 weeks and with a birth weight ≥2000 grams within 72 hours after birth
- Infants who are born at study centers
- Infants with the informed consent obtained from the parents or legal guardians
Key exclusion criteria (4 listed)
- Immediate requirement of respiratory support after birth (e.g., mechanical ventilation, nasal high-flow cannula oxygen therapy)
- Mothers who have active tobacco smoking or continuous environmental tobacco exposure during pregnancy
- Major congenital anomalies (e.g., cardiac or lung abnormalities, lethal chromosomal defects)
- The presence of injury of nasal mucosa, choanal atresia or Pierre Robin Sequence
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 |
|---|---|---|
| End-tidal carbon monoxide-corrected (ETCOc)Early postnatal ETCOc levels | Diagnostic test | Neonates with hemolytic hyperbilirubinemia, Neonates without hemolytic hyperbilirubinemia |
Primary outcome
The incidence of hemolytic hyperbilirubinemia within 14 days of life (DOL)
Time frame: Within 14 days of life (DOL)
The incidence of neonatal hyperbilirubinemia and hemolytic diseases of newborns
2 secondary outcomes
The incidence of neonatal hyperbilirubinemia within 14 days of life (DOL)
Time frame: Within 14 days of life (DOL)
The incidence of hemolytic diseases of newborns within 14 days of life (DOL)
Time frame: Within 14 days of life (DOL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
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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.
Huayan Zhang, M.D. principal investigator
Guangzhou Women and Children's Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Jaundice and Neonatal Hyperbilirubinemia, run by Guangzhou Women and Children's Medical Center at 7 sites in China.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ge Yang, M.D. ((86)020-38076329, geyang99@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hemolytic hyperbilirubinemia within 14 days of life (DOL) (time frame: Within 14 days of life (DOL)). 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 2 Apr 2024.