Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
NCT ID: NCT05949788
Last Updated: 2025-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
146 participants
OBSERVATIONAL
2023-03-01
2024-03-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
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
Interventions
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No intervention
Retrospect study, no direct intervention
Eligibility Criteria
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Inclusion Criteria
* Anemia was defined as a central venous hemoglobin harvested in the first 3 days of life less than two standard deviations below the mean for postnatal age.
Exclusion Criteria
* Twin-to twin-transfusion syndrome,
* Discordant twins (difference in birth weight \>20%),
* Major congenital anomalies or chromosomal anomalies,
* Disagree of parents.
4 Months
ALL
No
Sponsors
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Longhua Hospital Of Baoan District, Shenzhen
OTHER
Shenzhen Bao'an Maternal and Child Health Hospital
OTHER
Responsible Party
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Jun Luo
Principal Investigator
Principal Investigators
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Jun Luo, M.D.
Role: STUDY_DIRECTOR
Shenzhen Bao'an Maternal and Child Health Hospital
Locations
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Shenzhen Bao'an Maternal and Child Health Hospital
Shenzhen, Guangdong, China
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ShenzhenBMCHH
Identifier Type: -
Identifier Source: org_study_id
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