Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.

NCT ID: NCT05949788

Last Updated: 2025-01-27

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-03-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Very Preterm Maturity of Infant The Risk Factors for Improving the Prognosis of VLBW Infants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

Retrospect study, no direct intervention

Interventions

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No intervention

Retrospect study, no direct intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
* 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

* Asphyxia (arterial pH \<7.0, fifth minute Apgar score \<3),
* Twin-to twin-transfusion syndrome,
* Discordant twins (difference in birth weight \>20%),
* Major congenital anomalies or chromosomal anomalies,
* Disagree of parents.
Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Longhua Hospital Of Baoan District, Shenzhen

OTHER

Sponsor Role collaborator

Shenzhen Bao'an Maternal and Child Health Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jun Luo

Principal Investigator

Responsibility Role 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

Site Status

Countries

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China

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.

Reference Type BACKGROUND
PMID: 37350698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26934258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35901846 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34933821 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ShenzhenBMCHH

Identifier Type: -

Identifier Source: org_study_id

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