Fetal HemoglobinNCT05788562
The Relevance Between the Level of Fetal Hemoglobin and Short-term Complications in Extremely Preterm Infants
An observational study of Fetal Hemoglobin, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
A monocentric prospective study was conducted to find the relevance between the level of fetal hemoglobin and short-term complications in extremely preterm infants Read more about this study
- Who is it for?
- Ages 1 day to 2 months
- Conditions the study is for
- Fetal Hemoglobin
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day to 2 months
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants with gestational age <32 weeks or birth weight <1500g
Who may be able to join
- Preterm infants with gestational age <32 weeks or birth weight <1500g
- Parents agree to attend
Who cannot join
- serious functional or organic diseases
- severe congenital deformity
- parents reject to attend
Trial locations and contacts
1 site in 1 country.
China1 site
First hospital of Jilin University
Changchun, Jilin, 130000
Qu Yangming, +8615844092520, quym@jlu.edu.cn
About this study
A monocentric prospective study was conducted to find the relevance between the level of fetal hemoglobin and short-term complications in extremely preterm infants
- Conditions
- Fetal Hemoglobin
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Incorporate blood gas analysis indicators in D1-D7, after birth,1 week before and on the day of onset of early complications | |
| Control group | Incorporate blood gas analysis indicators in D1-D7,D14,D28after birth and the day of diacharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and severity of early complications in premature infants
include necrotizing enterocolitis,bronchopulmonary dysplasia,retinopathy, Intraventricular hemorrhage above degree Ⅱ,leukomalacia,late-onset sepsis
Measured: 2022.1-2023.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion18 Feb 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal HemoglobinStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788562
- Sponsor's protocol ID
- wu hui
- Status last verified
- Jun 2022
- First submitted
- 15 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relevance Between the Level of Fetal Hemoglobin and Short-term Complications in Extremely Preterm Infants
- ClinicalTrials.gov ID
- NCT05788562
- Acronym / sponsor ID
- wu hui
- Conditions
- Fetal Hemoglobin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 18 Feb 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A monocentric prospective study was conducted to find the relevance between the level of fetal hemoglobin and short-term complications in extremely preterm infants
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | –Incorporate blood gas analysis indicators in D1-D7, after birth,1 week before and on the day of onset of early complications |
| Control group | – | –Incorporate blood gas analysis indicators in D1-D7,D14,D28after birth and the day of diacharge |
Who may qualify
- Ages
- 1 day to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants with gestational age <32 weeks or birth weight <1500g
Key inclusion criteria (2 listed)
- Preterm infants with gestational age <32 weeks or birth weight <1500g
- Parents agree to attend
Key exclusion criteria (3 listed)
- serious functional or organic diseases
- severe congenital deformity
- parents reject to attend
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence and severity of early complications in premature infants
Time frame: 2022.1-2023.1
include necrotizing enterocolitis,bronchopulmonary dysplasia,retinopathy, Intraventricular hemorrhage above degree Ⅱ,leukomalacia,late-onset sepsis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No
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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.
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 Fetal Hemoglobin, run by The First Hospital of Jilin University 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 3 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qu Yangming (15844092520, quym@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence and severity of early complications in premature infants (time frame: 2022.1-2023.1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2023.