Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06341582 |
| Other study ID # |
2023-10-14 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 11, 2023 |
| Est. completion date |
November 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Guangzhou Women and Children's Medical Center |
| Contact |
Ge Yang, M.D. |
| Phone |
(86)020-38076329 |
| Email |
geyang99[@]outlook.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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 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.
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:
1. Early postnatal (≤72 hours) ETCOc levels
2. ETCOc levels within 14 days after birth
3. ETCOc levels before each phototherapy and/or exchange transfusion treatment
4. 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.
