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Completed

NCT Number: NCT05949788

Analyses of Anemia in Very Low Birth Weight (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.

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Key information

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Shenzhen Bao'an Maternal and Child Health Hospital

Shenzhen, Guangdong, 518102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Retrospect study, no direct intervention

Primary outcomes

  1. The Incidence of Early Onset Sepsis in VLBW Infants With AOP.

    Time frame: through study completion, an average of 6 months

    The incidence of early onset sepsis in very low birth weigh (VLBW) infants with anemia of prematurity (AOP)

Secondary outcomes

  1. The Maternal Hb Levels Before Birth Among VLBW Infants With AOP.

    Time frame: Through study completion, an average of 6 months

    The maternal hemoglobin (Hb) levels in very low birth weight (VLBW) infants with anemia of prematurity (AOP)

  2. Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP)

    Time frame: Through study completion, an average of 6 months

    The incidence of death and morbidity among extremely preterm infants with AOP and without.

Sponsors and collaborators

Lead sponsor

Shenzhen Bao'an Maternal and Child Health Hospital

Other

Collaborators

  • Longhua Hospital Of Baoan District, Shenzhen

Registry information

Official study title

Analyses of Anemia Risk Factors and Prognosis in VLBW Infants.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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