Necrotizing EnterocolitisPIPINCT06045130
PUFAs in Preterm Infants
An observational study of Necrotizing Enterocolitis and Intraventricular Hemorrhage, run by The First Hospital of Jilin University.
Trial summary
The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Necrotizing Enterocolitis, Intraventricular Hemorrhage, BPD - Bronchopulmonary Dysplasia
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2023to 31 Aug 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neonates born within 24 hours who were admitted to the Neonatology Department of the First Hospital of Jilin University, including premature infants born between 24 and 36 weeks of gestational age and full-term infants from September 2023 to August 2026, n
Who may be able to join
- Infants born between 24 and 36 weeks of gestational age who are admitted within 24 hours of birth, including both premature and full-term newborns.
- -
Who cannot join
- Infants with severe congenital developmental abnormalities, those requiring external supplementation of PUFAs in addition to standard intravenous nutrition and breastfeeding, and those with a severe prognosis indicating non-survival during their hospitalization.
- -
About this study
Official title: Characteristics of PUFAs Composition in Preterm Infants and Its Impact on Disease Prognosis
The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.
- Conditions
- Necrotizing Enterocolitis, Intraventricular Hemorrhage, BPD - Bronchopulmonary Dysplasia, Sepsis, Periventricular Leukomalacia, Patent Ductus Arteriosus
- Keywords
- PUFAs
- Medical subject headings
- Enterocolitis, Necrotizing, Bronchopulmonary Dysplasia, Sepsis, Leukomalacia, Periventricular, Ductus Arteriosus, Patent
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and severe complications of premature infants
incidence of death，NEC，PDA，BPD，IVH，PVL and sepsis
Measured: before discharge
Secondary outcomes (7)
Mortality
death
Measured: before discharge
NEC
Bell stage II or III
Measured: before discharge
PDA
confirmed by echocardiography
Measured: before discharge
BPD
nasal CPAP/NIPPV or invasive ventilation requirement at 36 weeks postmenstrual age or at discharge, transfer or death if before 36 weeks
Measured: before discharge
IVH
Papile grades 3-4
Measured: before discharge
PVL
periventricular cysts on cranial ultrasound or magnetic resonance imaging
Measured: before discharge
sepsis
blood culture positive
Measured: before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start21 Sep 2023 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies 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
- Prospective
- Enrolment
- 600 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
- NCT06045130
- Sponsor's protocol ID
- 2023-HS-050
- Acronym
- PIPI
- Status last verified
- Aug 2023
- First submitted
- 13 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of PUFAs Composition in Preterm Infants and Its Impact on Disease Prognosis
- ClinicalTrials.gov ID
- NCT06045130
- Acronym / sponsor ID
- PIPI / 2023-HS-050
- Conditions
- Necrotizing Enterocolitis, Intraventricular Hemorrhage, BPD - Bronchopulmonary Dysplasia, Sepsis, Periventricular Leukomalacia, Patent Ductus Arteriosus
- Keywords
- PUFAs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 21 Sep 2023 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 Sep 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.
The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neonates born within 24 hours who were admitted to the Neonatology Department of the First Hospital of Jilin University, including premature infants born between 24 and 36 weeks of gestational age and full-term infants from September 2023 to August 2026, n
Key inclusion criteria (2 listed)
- Infants born between 24 and 36 weeks of gestational age who are admitted within 24 hours of birth, including both premature and full-term newborns.
- -
Key exclusion criteria (2 listed)
- Infants with severe congenital developmental abnormalities, those requiring external supplementation of PUFAs in addition to standard intravenous nutrition and breastfeeding, and those with a severe prognosis indicating non-survival during their hospitalization.
- -
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
Mortality and severe complications of premature infants
Time frame: before discharge
incidence of death，NEC，PDA，BPD，IVH，PVL and sepsis
7 secondary outcomes
Mortality
Time frame: before discharge
NEC
Time frame: before discharge
PDA
Time frame: before discharge
BPD
Time frame: before discharge
IVH
Time frame: before discharge
PVL
Time frame: before discharge
sepsis
Time frame: before discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis and Intraventricular Hemorrhage, run by The First Hospital of Jilin University.
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 2 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Mortality and severe complications of premature infants (time frame: before discharge). 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 21 Sep 2023.