Infant, PrematureNCT03136172
Monitoring of Systemic or Organ Perfusion for Preterm Infants
An observational study of Infant, Premature and Hypoperfusion in Newborn, run by Inha University Hospital at 1 site in South Korea.
Trial summary
To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Infant, Premature, Hypoperfusion in Newborn, Necrotizing Enterocolitis of Newborn
- What is being tested?
- NIRS (near Infra-red spectroscopy)
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 May 2017to 31 Dec 2018
- 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 Up to 2 months
- All sexes
- No healthy volunteers
- Child
Study population: premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight
Who may be able to join
- premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight
Who cannot join
- infants without the consent of their guardians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on Monitoring of Systemic or Organ Blood Circulation and Perfusion for Preterm Infants
To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants. It includes near-infrared spectroscopy (NIRS), pulse oximetry with perfusion index (PI) and pleth variability index (PVI) and functional echocardiography.
Read the detailed description
Hemodynamic observational comparisons will be performed in 6 episodes below on each patient.
- first 24 hours after birth
- during red blood cell (RBC) transfusion: from 4 hours before to 4 hours after the transfusion
- suspicion of necrotizing enterocolitis: from the suspicion point for 48 hours
- suspicion of sepsis: from the suspicion point for 48 hours
- oligouria (< 1 mL/kg/hour of urine): for 48 hours
- hypotension (mean blood pressure < 30 mmHg): for 48 hours
- Conditions
- Infant, Premature, Hypoperfusion in Newborn, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Oliguria, Hypotension
- Being tested
- NIRS (near Infra-red spectroscopy)
- Medical subject headings
- Premature Birth, Neonatal Sepsis, Oliguria, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS (near Infra-red spectroscopy)Device
Also called Pulse oximetry, Echocardiography
- NIRS, INVOS 5100 cerebral/somatic oximeter monitor (Somanetics Corp, Troy, Michigan, USA)
- Radical-7 pulse oximeter (Masimo Corp, Irvine, CA, USA)
- Echocardiography (Phillips HD 15 Ultrasound system, CA, USA)
| Study group | Role | What they receive |
|---|---|---|
| Premature infant | premature infants with 32 weeks or less gestational age or 1,500 g or less birth weight, who born in the Inha university hospital and admit to the neonatal intensive care unit of the Inha university hospital Receives: Device: NIRS (near Infra-red spectroscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value of each index on hypotension
Positive predictive value of each index which are recorded through the monitoring machines
Measured: first 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start8 May 2017
- Primary completion1 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juyoung Lee, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136172
- Sponsor's protocol ID
- Neoperfusion-2017
- Status last verified
- Feb 2019
- First submitted
- 27 Apr 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- 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 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Monitoring of Systemic or Organ Blood Circulation and Perfusion for Preterm Infants
- ClinicalTrials.gov ID
- NCT03136172
- Acronym / sponsor ID
- Neoperfusion-2017
- Conditions
- Infant, Premature, Hypoperfusion in Newborn, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Oliguria, Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 May 2017 (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.
To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants. It includes near-infrared spectroscopy (NIRS), pulse oximetry with perfusion index (PI) and pleth variability index (PVI) and functional echocardiography.
Detailed description
Hemodynamic observational comparisons will be performed in 6 episodes below on each patient.
- first 24 hours after birth
- during red blood cell (RBC) transfusion: from 4 hours before to 4 hours after the transfusion
- suspicion of necrotizing enterocolitis: from the suspicion point for 48 hours
- suspicion of sepsis: from the suspicion point for 48 hours
- oligouria (< 1 mL/kg/hour of urine): for 48 hours
- hypotension (mean blood pressure < 30 mmHg): for 48 hours
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature infant | – | Device: NIRS (near Infra-red spectroscopy)premature infants with 32 weeks or less gestational age or 1,500 g or less birth weight, who born in the Inha university hospital and admit to the neonatal intensive care unit of the Inha university hospital |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight
Key inclusion criteria (1 listed)
- premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight
Key exclusion criteria (1 listed)
- infants without the consent of their guardians
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 |
|---|---|---|
| NIRS (near Infra-red spectroscopy)Also: Pulse oximetry, Echocardiography1. NIRS, INVOS 5100 cerebral/somatic oximeter monitor (Somanetics Corp, Troy, Michigan, USA) 2. Radical-7 pulse oximeter (Masimo Corp, Irvine, CA, USA) 3. Echocardiography (Phillips HD 15 Ultrasound system, CA, USA) | Device | Premature infant |
Primary outcome
Positive predictive value of each index on hypotension
Time frame: first 24 hours after birth
Positive predictive value of each index which are recorded through the monitoring machines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infant, Premature and Hypoperfusion in Newborn, run by Inha University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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 Feb 2019. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive predictive value of each index on hypotension (time frame: first 24 hours after birth). 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 27 Feb 2019.