The Risk Factors for Improving the Prognosis of VLBW Infants, Very Preterm Maturity of Infant
Conditions
Keywords
VLBW, anemia, risk factors, prognosis
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.
Interventions
OTHERNo intervention
Retrospect study, no direct intervention
Sponsors
Longhua Hospital Of Baoan District, Shenzhen
Shenzhen Bao'an Maternal and Child Health Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Participant flow
Recruitment details
This was a retrospective study on the maternal and infant clinical and electronic records.146 extremely preterm infants with a gestational age of less than 28 weeks were admitted to Bao'an Women's and Children's Hospital affiliated with Jinan University and Longhua District Women's and Children's Hospital from January 1, 2020 to December 31, 2022.
Pre-assignment details
45 extremely preterm infants were excluded due to severe birth deformity, twin-twin transfusion syndrome, neonatal hemolytic disease, death within 14 days after birth or transfer to another hospital.
Participants by arm
| Arm | Count |
|---|---|
| Anemia Group The very low birth weight (VLBW) infants meet the diagnostic criteria of neonatal anemia during hospitalization between January 2020 and January 2023.
No intervention: Retrospect study, no direct intervention | 25 |
| Control Group The very low birth weight (VLBW) infants are included without anemia during hospitalization between January 2020 and January 2023.
No intervention: Retrospect study, no direct intervention | 76 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | death within 14 days after birth | 2 | 6 |
| Overall Study | neonatal hemolytic disease | 3 | 8 |
| Overall Study | severe birth deformity | 2 | 7 |
| Overall Study | transfer to another hospital | 2 | 6 |
| Overall Study | twin-twin transfusion syndrome | 2 | 7 |
Baseline characteristics
| Characteristic | Control Group | Total | Anemia Group |
|---|---|---|---|
| Age, Continuous Gestational age | 26.79 weeks (gestational age) | 26.43 weeks (gestational age) | 26 weeks (gestational age) |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment China | 76 participants | 101 participants | 25 participants |
| Sex: Female, Male Female | 28 Participants | 39 Participants | 11 Participants |
| Sex: Female, Male Male | 48 Participants | 62 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 36 | 10 / 110 |
| other Total, other adverse events | 20 / 36 | 45 / 110 |
| serious Total, serious adverse events | 5 / 36 | 10 / 110 |
Outcome results
Primary
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)
Time frame: through study completion, an average of 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anemia Group | The Incidence of Early Onset Sepsis in VLBW Infants With AOP. | Early onset sepsis | 18 Participants |
| Anemia Group | The Incidence of Early Onset Sepsis in VLBW Infants With AOP. | Non-early onset sepsis | 7 Participants |
| Control Group | The Incidence of Early Onset Sepsis in VLBW Infants With AOP. | Early onset sepsis | 34 Participants |
| Control Group | The Incidence of Early Onset Sepsis in VLBW Infants With AOP. | Non-early onset sepsis | 42 Participants |
Secondary
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.
Time frame: Through study completion, an average of 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anemia Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | NEC | 3 Participants |
| Anemia Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | IVH | 7 Participants |
| Anemia Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | ROP (greater than II) | 12 Participants |
| Anemia Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | EUGR | 3 Participants |
| Anemia Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | neonatal sepsis | 17 Participants |
| Anemia Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | Death | 3 Participants |
| Anemia Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | moderate or severe BPD | 7 Participants |
| Control Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | Death | 4 Participants |
| Control Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | moderate or severe BPD | 20 Participants |
| Control Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | ROP (greater than II) | 39 Participants |
| Control Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | NEC | 6 Participants |
| Control Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | neonatal sepsis | 39 Participants |
| Control Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | IVH | 16 Participants |
| Control Group | Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) | EUGR | 14 Participants |
Secondary
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)
Time frame: Through study completion, an average of 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Anemia Group | The Maternal Hb Levels Before Birth Among VLBW Infants With AOP. | 111 g/L |
| Control Group | The Maternal Hb Levels Before Birth Among VLBW Infants With AOP. | 107 g/L |