Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Anemia group The very low birth weight (VLBW) infants meet the diagnostic criteria of neonatal anemia during hospitalization between January 2020 and January 2023. |
Other: 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. |
Other: No intervention
Retrospect study, no direct intervention
|
Outcome Measures
Primary Outcome Measures
- Anemia of prematurity (AOP) development in very low birth weight (VLBW) infants [Through study completion, an average of three months]
The incidence of AOP in the first 72 hours of life in VLBW infants
Secondary Outcome Measures
- Risk factor of AOP among VLBW infants [Through study completion, an average of three months]
The maternal hemoglobin (Hb) levels before birth among VLBW infants with AOP and without.
- Mortality or Bronchopulmonary Dysplasia (BPD) among VLBW infants with AOP [Through study completion, an average of three months]
The incidence of death or BPD among VLBW infants with AOP and without.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Preterm infants less than 32 weeks of gestational age and birth weight below 1500 g and who survive to NICU are eligible for the trial.
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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:
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Asphyxia (arterial pH <7.0, fifth minute Apgar score <3),
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Twin-to twin-transfusion syndrome,
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Discordant twins (difference in birth weight >20%),
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Major congenital anomalies or chromosomal anomalies,
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Disagree of parents.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shenzhen Bao'an Maternal and Child Health Hospital | Shenzhen | Guangdong | China | 518102 |
Sponsors and Collaborators
- Shenzhen Bao'an Maternal and Child Health Hospital
- Longhua Hospital Of Baoan District, Shenzhen
Investigators
- Study Director: Jun Luo, M.D., Shenzhen Bao'an Maternal and Child Health Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- ShenzhenBMCHH