Clinical trial NCT05949788: Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
Official title: Analyses of Anemia Risk Factors and Prognosis in VLBW Infants.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Very Preterm Maturity of Infant
The Risk Factors for Improving the Prognosis of VLBW Infants
Keywords: VLBW
anemia
risk factors
prognosis
Lead sponsor: Shenzhen Bao'an Maternal and Child Health Hospital
Sponsor class: OTHER
Collaborators: name: Longhua Hospital Of Baoan District, Shenzhen
First posted: 2023-07-18
Enrollment: 146
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Incidence of Early Onset Sepsis in VLBW Infants With AOP.
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: The Maternal Hb Levels Before Birth Among VLBW Infants With AOP.
timeFrame: Through study completion, an average of 6 months
measure: Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP)
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Bao'an Maternal and Child Health Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Bao'an Maternal and Child Health Hospital
name: Jun Luo, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.