Very Preterm Maturity of InfantNCT05949788
Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
An observational study of Very Preterm Maturity of Infant and The Risk Factors for Improving the Prognosis of VLBW Infants, run by Shenzhen Bao'an Maternal and Child Health Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Very Preterm Maturity of Infant, The Risk Factors for Improving the Prognosis of VLBW Infants
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 24 Mar 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Bao'an Maternal and Child Health Hospital
Shenzhen, Guangdong, 518102
About this study
Official title: Analyses of Anemia Risk Factors and Prognosis in 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.
Read the 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.
- Conditions
- Very Preterm Maturity of Infant, The Risk Factors for Improving the Prognosis of VLBW Infants
- Being tested
- No intervention
- Keywords
- VLBW, anemia, risk factors, prognosis
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Retrospect study, no direct intervention
| Study group | Role | What they receive |
|---|---|---|
| Anemia group | The very low birth weight (VLBW) infants meet the diagnostic criteria of neonatal anemia during hospitalization between January 2020 and January 2023. Receives: Other: No intervention | |
| Control group | The very low birth weight (VLBW) infants are included without anemia during hospitalization between January 2020 and January 2023. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 6 months
Secondary outcomes (2)
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)
Measured: Through study completion, an average of 6 months
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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Mar 2023
- Primary completion13 Mar 2024
- Study completion24 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Very Preterm Maturity of InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Bao'an Maternal and Child Health Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Longhua Hospital Of Baoan District, Shenzhen
- Responsible party
- Principal investigator, Jun Luo, Shenzhen Bao'an Maternal and Child Health Hospital
- Investigators
- Jun Luo, M.D., Study director, Shenzhen Bao'an Maternal and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949788
- Sponsor's protocol ID
- ShenzhenBMCHH
- Status last verified
- Jan 2025
- First submitted
- 3 Jul 2023
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The outcomes of this study, including the risk factors of anemia in different periods of hospitalization and the influence of anemia in different degrees on prognosis among the very low birth weight (VLBW) infants.
Publications
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.
PubMed 37350698Patel 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.
PubMed 26934258Bellach 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.
PubMed 35901846Nesterenko 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.
PubMed 34933821
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyses of Anemia Risk Factors and Prognosis in VLBW Infants.
- ClinicalTrials.gov ID
- NCT05949788
- Acronym / sponsor ID
- ShenzhenBMCHH
- Conditions
- Very Preterm Maturity of Infant, The Risk Factors for Improving the Prognosis of VLBW Infants
- Keywords
- VLBW, anemia, risk factors, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Shenzhen Bao'an Maternal and Child Health HospitalUniversity, hospital or other
- Collaborators
- Longhua Hospital Of Baoan District, Shenzhen
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Posted 27 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anemia group | – | Other: No interventionThe very low birth weight (VLBW) infants meet the diagnostic criteria of neonatal anemia during hospitalization between January 2020 and January 2023. |
| Control group | – | Other: No interventionThe very low birth weight (VLBW) infants are included without anemia during hospitalization between January 2020 and January 2023. |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionRetrospect study, no direct intervention | Other | Anemia group, Control group |
Primary outcome
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)
2 secondary outcomes
The Maternal Hb Levels Before Birth Among VLBW Infants With AOP.
Time frame: Through study completion, an average of 6 months
Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP)
Time frame: Through study completion, an average of 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37350698Everhart 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.
- Background: PubMed 26934258Patel 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.
- Background: PubMed 35901846Bellach 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.
- Background: PubMed 34933821Nesterenko 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.
- Individual participant dataSharing planned: Undecided. The outcomes of this study, including the risk factors of anemia in different periods of hospitalization and the influence of anemia in different degrees on prognosis among the very low birth weight (VLBW) infants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Luo, M.D. study director
Shenzhen Bao'an Maternal and Child Health Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Preterm Maturity of Infant and The Risk Factors for Improving the Prognosis of VLBW Infants, run by Shenzhen Bao'an Maternal and Child Health Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Early Onset Sepsis in VLBW Infants With AOP. (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05949788, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.