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

Analyses of Anemia Risk Factors and Prognosis in VLBW Infants.

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.

Study Overview

• Status: Completed
• Conditions: Very Preterm Maturity of Infant; The Risk Factors for Improving the Prognosis of VLBW Infants
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518102
      • Shenzhen Bao'an Maternal and Child Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	The incidence of death and morbidity among extremely preterm infants with AOP and without.	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Shenzhen Bao'an Maternal and Child Health Hospital
• Collaborators: Longhua Hospital Of Baoan District, Shenzhen
• Investigators: Study Director: Jun Luo, M.D., Shenzhen Bao'an Maternal and Child Health Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): March 13, 2024
• Study Completion (Actual): March 24, 2024

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 16, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: prognosis; anemia; risk factors; VLBW
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: ShenzhenBMCHH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No