Trial Outcomes & Findings for Analyses of Anemia in Very Low Birth Weight (VLBW) Infants. (NCT NCT05949788)

NCT ID: NCT05949788

Last Updated: 2025-01-27

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 146 participants
• Primary outcome timeframe: through study completion, an average of 6 months
• Results posted on: 2025-01-27

Participant Flow

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.

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.

Participant milestones

Measure	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	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
Overall Study STARTED	36	110
Overall Study COMPLETED	25	76
Overall Study NOT COMPLETED	11	34

Reasons for withdrawal

Measure	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	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
Overall Study severe birth deformity	2	7
Overall Study twin-twin transfusion syndrome	2	7
Overall Study neonatal hemolytic disease	3	8
Overall Study death within 14 days after birth	2	6
Overall Study transfer to another hospital	2	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Anemia Group n=25 Participants 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	Control Group n=76 Participants 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	Total n=101 Participants Total of all reporting groups
Age, Continuous Gestational age	26 weeks (gestational age) n=25 Participants	26.79 weeks (gestational age) n=76 Participants	26.43 weeks (gestational age) n=101 Participants
Sex: Female, Male Female	11 Participants n=25 Participants	28 Participants n=76 Participants	39 Participants n=101 Participants
Sex: Female, Male Male	14 Participants n=25 Participants	48 Participants n=76 Participants	62 Participants n=101 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	25 participants n=25 Participants	76 participants n=76 Participants	101 participants n=101 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Anemia Group n=25 Participants 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	Control Group n=76 Participants 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
The Incidence of Early Onset Sepsis in VLBW Infants With AOP. Early onset sepsis	18 Participants	34 Participants
The Incidence of Early Onset Sepsis in VLBW Infants With AOP. Non-early onset sepsis	7 Participants	42 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Anemia Group n=25 Participants 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	Control Group n=76 Participants 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
The Maternal Hb Levels Before Birth Among VLBW Infants With AOP.	111 g/L Interval 94.5 to 120.5	107 g/L Interval 97.5 to 119.5

SECONDARY outcome

Timeframe: Through study completion, an average of 6 months

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

Outcome measures

Measure	Anemia Group n=25 Participants 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	Control Group n=76 Participants 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
Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) moderate or severe BPD	7 Participants	20 Participants
Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) ROP (greater than II)	12 Participants	39 Participants
Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) NEC	3 Participants	6 Participants
Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) Death	3 Participants	4 Participants
Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) neonatal sepsis	17 Participants	39 Participants
Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) IVH	7 Participants	16 Participants
Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP) EUGR	3 Participants	14 Participants

Adverse Events

Anemia Group

Serious events: 5 serious events

Other events: 20 other events

Deaths: 5 deaths

Control Group

Serious events: 10 serious events

Other events: 45 other events

Deaths: 10 deaths

Serious adverse events

Measure	Anemia Group n=36 participants at risk 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	Control Group n=110 participants at risk 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
Infections and infestations Death	5.6% 2/36 • Number of events 2 • "through study completion, an average of 6 months" Two in anemia group and six in non-anemia group were excluded due to death within 14 days after birth. Three of 25 patients in anemia group were died, and four of 76 patients in non-anemia group were died. In anemia group: Two died from late onset sepsis, another died from necrotizing enterocolitis. In non-anemia group: Four died from late onset sepsis.	5.5% 6/110 • Number of events 6 • "through study completion, an average of 6 months" Two in anemia group and six in non-anemia group were excluded due to death within 14 days after birth. Three of 25 patients in anemia group were died, and four of 76 patients in non-anemia group were died. In anemia group: Two died from late onset sepsis, another died from necrotizing enterocolitis. In non-anemia group: Four died from late onset sepsis.
Reproductive system and breast disorders Death	5.6% 2/36 • Number of events 2 • "through study completion, an average of 6 months" Two in anemia group and six in non-anemia group were excluded due to death within 14 days after birth. Three of 25 patients in anemia group were died, and four of 76 patients in non-anemia group were died. In anemia group: Two died from late onset sepsis, another died from necrotizing enterocolitis. In non-anemia group: Four died from late onset sepsis.	3.6% 4/110 • Number of events 4 • "through study completion, an average of 6 months" Two in anemia group and six in non-anemia group were excluded due to death within 14 days after birth. Three of 25 patients in anemia group were died, and four of 76 patients in non-anemia group were died. In anemia group: Two died from late onset sepsis, another died from necrotizing enterocolitis. In non-anemia group: Four died from late onset sepsis.
Gastrointestinal disorders Death	2.8% 1/36 • Number of events 1 • "through study completion, an average of 6 months" Two in anemia group and six in non-anemia group were excluded due to death within 14 days after birth. Three of 25 patients in anemia group were died, and four of 76 patients in non-anemia group were died. In anemia group: Two died from late onset sepsis, another died from necrotizing enterocolitis. In non-anemia group: Four died from late onset sepsis.	0.00% 0/110 • "through study completion, an average of 6 months" Two in anemia group and six in non-anemia group were excluded due to death within 14 days after birth. Three of 25 patients in anemia group were died, and four of 76 patients in non-anemia group were died. In anemia group: Two died from late onset sepsis, another died from necrotizing enterocolitis. In non-anemia group: Four died from late onset sepsis.

Other adverse events

Measure	Anemia Group n=36 participants at risk 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	Control Group n=110 participants at risk 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
Infections and infestations Neonatal sepsis	47.2% 17/36 • Number of events 17 • "through study completion, an average of 6 months" Two in anemia group and six in non-anemia group were excluded due to death within 14 days after birth. Three of 25 patients in anemia group were died, and four of 76 patients in non-anemia group were died. In anemia group: Two died from late onset sepsis, another died from necrotizing enterocolitis. In non-anemia group: Four died from late onset sepsis.	35.5% 39/110 • Number of events 39 • "through study completion, an average of 6 months" Two in anemia group and six in non-anemia group were excluded due to death within 14 days after birth. Three of 25 patients in anemia group were died, and four of 76 patients in non-anemia group were died. In anemia group: Two died from late onset sepsis, another died from necrotizing enterocolitis. In non-anemia group: Four died from late onset sepsis.
Gastrointestinal disorders NEC	8.3% 3/36 • Number of events 3 • "through study completion, an average of 6 months" Two in anemia group and six in non-anemia group were excluded due to death within 14 days after birth. Three of 25 patients in anemia group were died, and four of 76 patients in non-anemia group were died. In anemia group: Two died from late onset sepsis, another died from necrotizing enterocolitis. In non-anemia group: Four died from late onset sepsis.	5.5% 6/110 • Number of events 6 • "through study completion, an average of 6 months" Two in anemia group and six in non-anemia group were excluded due to death within 14 days after birth. Three of 25 patients in anemia group were died, and four of 76 patients in non-anemia group were died. In anemia group: Two died from late onset sepsis, another died from necrotizing enterocolitis. In non-anemia group: Four died from late onset sepsis.

Additional Information

Dr. Jun Luo

ShenzhenBMCHH

Phone: 015818671195

Email: luojun-78@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place