NCT05949788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 27, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

July 3, 2023

Results QC Date

June 26, 2024

Last Update Submit

January 23, 2025

Conditions

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

Keywords

VLBWanemiarisk factorsprognosis

Outcome Measures

Primary Outcomes (1)

  • 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)

    through study completion, an average of 6 months

Secondary Outcomes (2)

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

    Through study completion, an average of 6 months

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

    Through study completion, an average of 6 months

Study Arms (2)

Anemia group

The very low birth weight (VLBW) infants meet the diagnostic criteria of neonatal anemia during hospitalization between January 2020 and January 2023.

Other: No intervention

Control group

The very low birth weight (VLBW) infants are included without anemia during hospitalization between January 2020 and January 2023.

Other: No intervention

Interventions

No interventionOTHER

Retrospect study, no direct intervention

Anemia groupControl group

Eligibility Criteria

AgeUp to 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All the preterm infants less than 32 weeks of gestational age and birth weight below 1500 g and who survive to neonatal intensive care unit (NICU) are eligible for the trial between January 2020 and January 2023.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Bao'an Maternal and Child Health Hospital

Shenzhen, Guangdong, 518102, China

Location

Related Publications (4)

  • Everhart KC, Donevant SB, Iskersky VN, Wirth MD, Dail RB. Case Comparison of Preterm Infant Stability During Packed Red Blood Cell Transfusions. Nurs Res. 2023 Jul-Aug 01;72(4):301-309. doi: 10.1097/NNR.0000000000000658.

    PMID: 37350698BACKGROUND

  • Patel RM, Knezevic A, Shenvi N, Hinkes M, Keene S, Roback JD, Easley KA, Josephson CD. Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis in Very Low-Birth-Weight Infants. JAMA. 2016 Mar 1;315(9):889-97. doi: 10.1001/jama.2016.1204.

    PMID: 26934258BACKGROUND

  • Bellach L, Eigenschink M, Hassanein A, Savran D, Salzer U, Mullner EW, Repa A, Klebermass-Schrehof K, Wisgrill L, Giordano V, Berger A. Packed red blood cell transfusion in preterm infants. Lancet Haematol. 2022 Aug;9(8):e615-e626. doi: 10.1016/S2352-3026(22)00207-1.

    PMID: 35901846BACKGROUND

  • Nesterenko TH, Baliga N, Swaintek S, Abdelatif D, Aly H, Mohamed MA. The impact of a multifaceted quality improvement program on the incidence of necrotizing enterocolitis in very low birth weight infants. Pediatr Neonatol. 2022 Mar;63(2):181-187. doi: 10.1016/j.pedneo.2021.10.002. Epub 2021 Dec 5.

    PMID: 34933821BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Dr. Jun Luo
Organization
ShenzhenBMCHH
luojun-78@163.com
015818671195

Study Officials

  • Jun Luo, M.D.

    Shenzhen Bao'an Maternal and Child Health Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 18, 2023

Study Start

March 1, 2023

Primary Completion

March 13, 2024

Study Completion

March 24, 2024

Last Updated

January 27, 2025

Results First Posted

January 27, 2025

Record last verified: 2025-01

Locations

CN(1)