HyperbilirubinemiaEarly Phase 1NCT01550627
Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
A Early Phase 1 study testing extra fluid/iv fluid supplementation during phototherapy and Non extra fluid in people with Hyperbilirubinemia, run by University of Jena at 1 site in Germany.
Trial summary
The aim of the study was to evaluate the influence of a systematic extra intravenous fluid supplementation during phototherapy in comparison to a fluid supplementation due to short term demand in preterm infants. Read more about this study
- Who is it for?
- Ages 1 to 1 week
- Conditions the study is for
- Hyperbilirubinemia
- What is being tested?
- extra fluid/iv fluid supplementation during phototherapy and Non extra fluid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Jun 2009
- Phase
- Early Phase 1
- 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 to 1 week
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hyperbilirubinemia
Who cannot join
- Preterm infants > 33 weeks of gestation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Possible Effects of Intravenous Fluid Supplementation on Serum Bilirubin Levels and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
The aim of the study was to evaluate the influence of a systematic extra intravenous fluid supplementation during phototherapy in comparison to a fluid supplementation due to short term demand in preterm infants.
Read the detailed description
60 preterm infants (GA ≤ 32 week) were assigned randomly to either receive a fluid supplementation due to short term demand (control group, n=30;) or a 20% extra fluid supplementation (study group, n=30) during intermediate phototherapy.
Collected data:
- cardiorespiratory parameters(heart rate, blood pressure, SaO2 and capillary refill time, breathing rate, temperature) and a pain score was completed at the first day of phototherapy
- The maximum total serum bilirubin levels (TSB) within one week after onset of phototherapy
- Conditions
- Hyperbilirubinemia
- Being tested
- extra fluid/iv fluid supplementation during phototherapy, Non extra fluid
- Keywords
- preterm infants < 32 weeks of gestation
- Medical subject headings
- Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extra fluid/iv fluid supplementation during phototherapyOther
The study group received an extra intravenous fluid intake of 20% of the total fluid demand per 24 hours of NaCl 0,9% during each two hour period of phototherapy (12h total per day). The extra fluid intake was interrupted during the 12 hours break of phototherapy.
Non extra fluidOther
Control placebo The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake.
| Study group | Role | What they receive |
|---|---|---|
| extra-fluid | Active comparator | The study group received an extra intravenous fluid intake of 20% of the total fluid demand per 24 hours of NaCl 0,9% during each two hour period of phototherapy (12h total per day). Receives: Other: extra fluid/iv fluid supplementation during phototherapy |
| non extra fluid (control group) | Placebo comparator | The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake. Receives: Other: Non extra fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum total serum bilirubin levels
The maximum total serum bilirubin levels within on week after onset of phototherapy
Measured: within one week after onset of phototherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startNov 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperbilirubinemiaStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefanie Junge, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550627
- Sponsor's protocol ID
- 2127-10/09
- Status last verified
- Mar 2012
- First submitted
- 7 Feb 2012
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Possible Effects of Intravenous Fluid Supplementation on Serum Bilirubin Levels and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
- ClinicalTrials.gov ID
- NCT01550627
- Acronym / sponsor ID
- 2127-10/09
- Conditions
- Hyperbilirubinemia
- Keywords
- preterm infants < 32 weeks of gestation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 12 Mar 2012 (estimated)
- 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 aim of the study was to evaluate the influence of a systematic extra intravenous fluid supplementation during phototherapy in comparison to a fluid supplementation due to short term demand in preterm infants.
Detailed description
60 preterm infants (GA ≤ 32 week) were assigned randomly to either receive a fluid supplementation due to short term demand (control group, n=30;) or a 20% extra fluid supplementation (study group, n=30) during intermediate phototherapy.
Collected data:
- cardiorespiratory parameters(heart rate, blood pressure, SaO2 and capillary refill time, breathing rate, temperature) and a pain score was completed at the first day of phototherapy
- The maximum total serum bilirubin levels (TSB) within one week after onset of phototherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extra-fluid | Active comparator | Other: extra fluid/iv fluid supplementation during phototherapyThe study group received an extra intravenous fluid intake of 20% of the total fluid demand per 24 hours of NaCl 0,9% during each two hour period of phototherapy (12h total per day). |
| non extra fluid (control group) | Placebo comparator | Other: Non extra fluidThe control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake. |
Who may qualify
- Ages
- 1 to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Hyperbilirubinemia
Key exclusion criteria (1 listed)
- Preterm infants > 33 weeks of gestation
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 |
|---|---|---|
| extra fluid/iv fluid supplementation during phototherapyThe study group received an extra intravenous fluid intake of 20% of the total fluid demand per 24 hours of NaCl 0,9% during each two hour period of phototherapy (12h total per day). The extra fluid intake was interrupted during the 12 hours break of phototherapy. | Other | extra-fluid |
| Non extra fluidControl placebo The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake. | Other | non extra fluid (control group) |
Primary outcome
The maximum total serum bilirubin levels
Time frame: within one week after onset of phototherapy
The maximum total serum bilirubin levels within on week after onset of phototherapy
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 12 Mar 2012.
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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?
A Early Phase 1 study testing extra fluid/iv fluid supplementation during phototherapy and Non extra fluid in people with Hyperbilirubinemia, run by University of Jena at 1 site in Germany.
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 12 Mar 2012. 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The maximum total serum bilirubin levels (time frame: within one week after onset of phototherapy). 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 12 Mar 2012.