Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
- Conditions
- The Risk Factors for Improving the Prognosis of VLBW InfantsVery Preterm Maturity of Infant
- Interventions
- Other: No intervention
- Registration Number
- NCT05949788
- Lead Sponsor
- Shenzhen Bao'an Maternal and Child Health Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group No intervention The very low birth weight (VLBW) infants are included without anemia during hospitalization between January 2020 and January 2023. Anemia group No intervention The very low birth weight (VLBW) infants meet the diagnostic criteria of neonatal anemia during hospitalization between January 2020 and January 2023.
- Primary Outcome Measures
Name Time Method The Incidence of Early Onset Sepsis in VLBW Infants With AOP. 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 Outcome Measures
Name Time Method The Maternal Hb Levels Before Birth Among VLBW Infants With AOP. 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)
Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) Through study completion, an average of 6 months The incidence of death and morbidity among extremely preterm infants with AOP and without.
Trial Locations
- Locations (1)
Shenzhen Bao'an Maternal and Child Health Hospital
🇨🇳Shenzhen, Guangdong, China