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| Name | Class |
|---|---|
| Longhua Hospital Of Baoan District, Shenzhen | OTHER |
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To study and analyze the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life (less than 3 days of life) among the very low birth weight (VLBW) infants.
The rescue treatment of very low birth weight (VLBW) infants is the main task of our neonatal intensive care unit (NICU) is this era. Anemia of prematurity (AOP) is one of the most common complication of these infants, which can affect their growth, intelligence, behavior, immunity and hemodynamics, and even endanger their lives in severe situation. It is of great significance to investigate the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life for improving the prognosis of these infants.
Patient Registry procedures: First, the list of VLBW infants was obtained through medical record search, and sent to the principal investigator (PI) at each center when an infant was eligible for enrollment. Second, patients are included in this study according to the exclusion criteria by PI. Finally, the PI at each center will be responsible for the accuracy,completeness or representativeness of medical records, registry forms,data collection.
Statistical analysis:The two groups were compared by a Χ2-test for categorical variables, Mann-Whitney U Test were used when reporting medians.A P value of <0.05 was considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anemia group | The very low birth weight (VLBW) infants meet the diagnostic criteria of neonatal anemia during hospitalization between January 2020 and January 2023. |
| |
| Control group | The very low birth weight (VLBW) infants are included without anemia during hospitalization between January 2020 and January 2023. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Retrospect study, no direct intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Early Onset Sepsis in VLBW Infants With AOP. | The incidence of early onset sepsis in very low birth weigh (VLBW) infants with anemia of prematurity (AOP) | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Maternal Hb Levels Before Birth Among VLBW Infants With AOP. | The maternal hemoglobin (Hb) levels in very low birth weight (VLBW) infants with anemia of prematurity (AOP) | Through study completion, an average of 6 months |
| Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) |
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Inclusion Criteria:
Exclusion Criteria:
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All the preterm infants less than 32 weeks of gestational age and birth weight below 1500 g and who survive to neonatal intensive care unit (NICU) are eligible for the trial between January 2020 and January 2023.
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| Name | Affiliation | Role |
|---|---|---|
| Jun Luo, M.D. | Shenzhen Bao'an Maternal and Child Health Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Bao'an Maternal and Child Health Hospital | Shenzhen | Guangdong | 518102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37350698 | Background | Everhart KC, Donevant SB, Iskersky VN, Wirth MD, Dail RB. Case Comparison of Preterm Infant Stability During Packed Red Blood Cell Transfusions. Nurs Res. 2023 Jul-Aug 01;72(4):301-309. doi: 10.1097/NNR.0000000000000658. | |
| 26934258 | Background | Patel RM, Knezevic A, Shenvi N, Hinkes M, Keene S, Roback JD, Easley KA, Josephson CD. Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis in Very Low-Birth-Weight Infants. JAMA. 2016 Mar 1;315(9):889-97. doi: 10.1001/jama.2016.1204. |
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The outcomes of this study, including the risk factors of anemia in different periods of hospitalization and the influence of anemia in different degrees on prognosis among the very low birth weight (VLBW) infants.
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45 extremely preterm infants were excluded due to severe birth deformity, twin-twin transfusion syndrome, neonatal hemolytic disease, death within 14 days after birth or transfer to another hospital.
This was a retrospective study on the maternal and infant clinical and electronic records.146 extremely preterm infants with a gestational age of less than 28 weeks were admitted to Bao'an Women's and Children's Hospital affiliated with Jinan University and Longhua District Women's and Children's Hospital from January 1, 2020 to December 31, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anemia Group | The very low birth weight (VLBW) infants meet the diagnostic criteria of neonatal anemia during hospitalization between January 2020 and January 2023. No intervention: Retrospect study, no direct intervention |
| FG001 | Control Group | The very low birth weight (VLBW) infants are included without anemia during hospitalization between January 2020 and January 2023. No intervention: Retrospect study, no direct intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anemia Group | The very low birth weight (VLBW) infants meet the diagnostic criteria of neonatal anemia during hospitalization between January 2020 and January 2023. No intervention: Retrospect study, no direct intervention |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | the median gestational age in anemia group |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Incidence of Early Onset Sepsis in VLBW Infants With AOP. | The incidence of early onset sepsis in very low birth weigh (VLBW) infants with anemia of prematurity (AOP) | Posted | Count of Participants | Participants | No | through study completion, an average of 6 months |
|
"through study completion, an average of 6 months"
Two in anemia group and six in non-anemia group were excluded due to death within 14 days after birth.
Three of 25 patients in anemia group were died, and four of 76 patients in non-anemia group were died.
In anemia group: Two died from late onset sepsis, another died from necrotizing enterocolitis.
In non-anemia group: Four died from late onset sepsis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anemia Group | The very low birth weight (VLBW) infants meet the diagnostic criteria of neonatal anemia during hospitalization between January 2020 and January 2023. No intervention: Retrospect study, no direct intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Infections and infestations | Systematic Assessment | In anemia group: Two died from late onset sepsis. In non-anemia group: Six died from late onset sepsis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neonatal sepsis | Infections and infestations | Systematic Assessment | Neonatal sepsis diagnosis required positive culture along with clinical signs (fever; hypothermia; lethargy; tachypnea; apnea/bradycardia; cyanosis; and hypoglycemia not explained by other diagnoses) or laboratory signs of infection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jun Luo | ShenzhenBMCHH | 015818671195 | luojun-78@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2023 | Oct 14, 2024 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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The incidence of death and morbidity among extremely preterm infants with AOP and without. |
| Through study completion, an average of 6 months |
| 35901846 | Background | Bellach L, Eigenschink M, Hassanein A, Savran D, Salzer U, Mullner EW, Repa A, Klebermass-Schrehof K, Wisgrill L, Giordano V, Berger A. Packed red blood cell transfusion in preterm infants. Lancet Haematol. 2022 Aug;9(8):e615-e626. doi: 10.1016/S2352-3026(22)00207-1. |
| 34933821 | Background | Nesterenko TH, Baliga N, Swaintek S, Abdelatif D, Aly H, Mohamed MA. The impact of a multifaceted quality improvement program on the incidence of necrotizing enterocolitis in very low birth weight infants. Pediatr Neonatol. 2022 Mar;63(2):181-187. doi: 10.1016/j.pedneo.2021.10.002. Epub 2021 Dec 5. |
| neonatal hemolytic disease |
|
| death within 14 days after birth |
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| transfer to another hospital |
|
The very low birth weight (VLBW) infants are included without anemia during hospitalization between January 2020 and January 2023. No intervention: Retrospect study, no direct intervention |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| weeks (gestational age) |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Maternal Hb Levels Before Birth Among VLBW Infants With AOP. | The maternal hemoglobin (Hb) levels in very low birth weight (VLBW) infants with anemia of prematurity (AOP) | Posted | Median | Inter-Quartile Range | g/L | Through study completion, an average of 6 months |
|
|
|
| Secondary | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | The incidence of death and morbidity among extremely preterm infants with AOP and without. | Posted | Count of Participants | Participants | Through study completion, an average of 6 months |
|
|
|
| 5 |
| 36 |
| 5 |
| 36 |
| 20 |
| 36 |
| EG001 | Control Group | The very low birth weight (VLBW) infants are included without anemia during hospitalization between January 2020 and January 2023. No intervention: Retrospect study, no direct intervention | 10 | 110 | 10 | 110 | 45 | 110 |
|
| Death | Reproductive system and breast disorders | Systematic Assessment | One in anemia group and two in non-anemia group were died from respiratory failure within 14 days after birth.One in anemia group and two in non-anemia group were died from pneumothorax within 14 days after birth. |
|
| Death | Gastrointestinal disorders | Systematic Assessment | One in anemia group died from necrotizing enterocolitis. |
|
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| NEC | Gastrointestinal disorders | Systematic Assessment | NEC was defined as stage 2 or higher based on Bell's criteria. |
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| NEC |
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| neonatal sepsis |
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| IVH |
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| EUGR |
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| Death |
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