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

S

Shenzhen Bao'an Maternal and Child Health Hospital

Status

Completed

Conditions

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

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT05949788
ShenzhenBMCHH

Details and patient eligibility

About

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.

Full 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.

Enrollment

146 patients

Sex

All

Ages

Under 4 months old

Volunteers

No Healthy Volunteers

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.

Trial design

146 participants in 2 patient groups

Anemia group
Description:
The very low birth weight (VLBW) infants meet the diagnostic criteria of neonatal anemia during hospitalization between January 2020 and January 2023.
Treatment:
Other: No intervention
Control group
Description:
The very low birth weight (VLBW) infants are included without anemia during hospitalization between January 2020 and January 2023.
Treatment:
Other: No intervention

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Fen Xu, M.D.; Jun Luo, M.D.

Data sourced from clinicaltrials.gov

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