Very Low Birth Weight InfantPhase 4NCT00962754
Fluid Balance Study in Sick Neonates
A Phase 4 study testing physician no insight in the fluid balance chart in people with Very Low Birth Weight Infant, run by Princess Amalia Children's Clinic at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine if routinely recording fluid balance in sick neonates admitted to the pediatric ward is reliable and useful. The investigators' hypothesis is that it is not useful and reliable. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Very Low Birth Weight Infant
- What is being tested?
- physician no insight in the fluid balance chart
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2009to Mar 2010
- Phase
- Phase 4
- 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 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Sick neonates admitted to the neonatal ward
Who cannot join
- Admitted elsewhere before admission to the neonatal ward
- Indication for recording fluid balance
- Impossibility to measure the weight every day
- No consent parents
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Princess Amalia Children's Clinic
Zwolle, Overijssel, 8000GK
About this study
Official title: Reliability and Utility of Fluid Balance Charting in Neonates Admitted to the Pediatric Ward.
The purpose of this study is to determine if routinely recording fluid balance in sick neonates admitted to the pediatric ward is reliable and useful. The investigators' hypothesis is that it is not useful and reliable.
Read the detailed description
Fluid balance charts are commonly used, in the Netherlands, to assess patient fluid volume status. Some disadvantages of recording fluid intake and output are that it is time-consuming and complex. If it would give reliable and accurate information about the fluid volume status there would be a good reason for all this effort. In the few researches that have investigated this subject a low correlation has been found between the fluid balance and the weight changes of an adult patient. Own experience gives reasons to doubt about the reliability of the fluid balance in children, not rarely there is a discrepancy between the fluid balance and the weight measurement. We are interested in the relevance of recording fluid balance in neonates.
- Conditions
- Very Low Birth Weight Infant
- Being tested
- physician no insight in the fluid balance chart
- Keywords
- recording fluid balance, reliability, utility, sick neonate, fluid balance, inpatient, sick
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physician no insight in the fluid balance chartProcedure or surgery
physician had no insight in the fluid balance chart during the first 3 days of admission of the patient when the balance is recorded
| Study group | Role | What they receive |
|---|---|---|
| physician insight fluid balance | No intervention | physician has insight in fluid balance chart, this is standard practice |
| fluid balance data masked to physician | Experimental | physician no insight in the fluid balance chart Receives: Procedure: physician no insight in the fluid balance chart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Admission at the Ward in Days
Duration of hospital stay in days or duration of admission at the pediatric ward in days
Measured: 1-8 months
Secondary outcomes (2)
Use of Diuretics
prescription of diuretic therapy
Measured: during days of admission
Complications
notifications of complications
Measured: duration of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2010
- Study completionMar 2010
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 (8)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Amalia Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolita Bekhof, Princess Amalia Children's Clinic
- Investigators
- J Bekhof, pediatrician, Study director, Princess Amalia Children's ClinicY v Asperen, MD, Principal investigator, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962754
- Sponsor's protocol ID
- NL26894.075.09
- Status last verified
- Apr 2014
- First submitted
- 18 Aug 2009
- Last updated
- 7 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Daffurn K, Hillman KM, Bauman A, Lum M, Crispin C, Ince L. Fluid balance charts: do they measure up? Br J Nurs. 1994 Sep 8-21;3(16):816-20. doi: 10.12968/bjon.1994.3.16.816.
PubMed 7950261Chung LH, Chong S, French P. The efficiency of fluid balance charting: an evidence-based management project. J Nurs Manag. 2002 Mar;10(2):103-13. doi: 10.1046/j.0966-0429.2001.00296.x.
PubMed 11882111Wise LC, Mersch J, Racioppi J, Crosier J, Thompson C. Evaluating the reliability and utility of cumulative intake and output. J Nurs Care Qual. 2000 Apr;14(3):37-42. doi: 10.1097/00001786-200004000-00005.
PubMed 10826233Eastwood GM. Evaluating the reliability of recorded fluid balance to approximate body weight change in patients undergoing cardiac surgery. Heart Lung. 2006 Jan-Feb;35(1):27-33. doi: 10.1016/j.hrtlng.2005.06.001.
PubMed 16426933Mank A, Semin-Goossens A, Lelie Jv, Bakker P, Vos R. Monitoring hyperhydration during high-dose chemotherapy: body weight or fluid balance? Acta Haematol. 2003;109(4):163-8. doi: 10.1159/000070964.
PubMed 12853687Pflaum SS. Investigation of intake-output as a means of assessing body fluid balance. Heart Lung. 1979 May-Jun;8(3):495-8.
PubMed 254670Scales K, Pilsworth J. The importance of fluid balance in clinical practice. Nurs Stand. 2008 Jul 30-Aug 5;22(47):50-7; quiz 58, 60. doi: 10.7748/ns2008.07.22.47.50.c6634.
PubMed 18777823Bekhof J, van Asperen Y, Brand PL. Usefulness of the fluid balance: a randomised controlled trial in neonates. J Paediatr Child Health. 2013 Jun;49(6):486-92. doi: 10.1111/jpc.12214. Epub 2013 May 2.
PubMed 23635344
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Utility of Fluid Balance Charting in Neonates Admitted to the Pediatric Ward.
- ClinicalTrials.gov ID
- NCT00962754
- Acronym / sponsor ID
- NL26894.075.09
- Conditions
- Very Low Birth Weight Infant
- Keywords
- recording fluid balance, reliability, utility, sick neonate, fluid balance, inpatient, sick
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Princess Amalia Children's ClinicUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 20 Aug 2009 (estimated)
- Results
- Posted 7 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if routinely recording fluid balance in sick neonates admitted to the pediatric ward is reliable and useful. The investigators' hypothesis is that it is not useful and reliable.
Detailed description
Fluid balance charts are commonly used, in the Netherlands, to assess patient fluid volume status. Some disadvantages of recording fluid intake and output are that it is time-consuming and complex. If it would give reliable and accurate information about the fluid volume status there would be a good reason for all this effort. In the few researches that have investigated this subject a low correlation has been found between the fluid balance and the weight changes of an adult patient. Own experience gives reasons to doubt about the reliability of the fluid balance in children, not rarely there is a discrepancy between the fluid balance and the weight measurement. We are interested in the relevance of recording fluid balance in neonates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physician insight fluid balance | No intervention | –physician has insight in fluid balance chart, this is standard practice |
| fluid balance data masked to physician | Experimental | Procedure: physician no insight in the fluid balance chartphysician no insight in the fluid balance chart |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Sick neonates admitted to the neonatal ward
Key exclusion criteria (4 listed)
- Admitted elsewhere before admission to the neonatal ward
- Indication for recording fluid balance
- Impossibility to measure the weight every day
- No consent 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 |
|---|---|---|
| physician no insight in the fluid balance chartphysician had no insight in the fluid balance chart during the first 3 days of admission of the patient when the balance is recorded | Procedure or surgery | fluid balance data masked to physician |
Primary outcome
Duration of Admission at the Ward in Days
Time frame: 1-8 months
Duration of hospital stay in days or duration of admission at the pediatric ward in days
2 secondary outcomes
Use of Diuretics
Time frame: during days of admission
Complications
Time frame: duration of admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7950261Daffurn K, Hillman KM, Bauman A, Lum M, Crispin C, Ince L. Fluid balance charts: do they measure up? Br J Nurs. 1994 Sep 8-21;3(16):816-20. doi: 10.12968/bjon.1994.3.16.816.
- Background: PubMed 11882111Chung LH, Chong S, French P. The efficiency of fluid balance charting: an evidence-based management project. J Nurs Manag. 2002 Mar;10(2):103-13. doi: 10.1046/j.0966-0429.2001.00296.x.
- Background: PubMed 10826233Wise LC, Mersch J, Racioppi J, Crosier J, Thompson C. Evaluating the reliability and utility of cumulative intake and output. J Nurs Care Qual. 2000 Apr;14(3):37-42. doi: 10.1097/00001786-200004000-00005.
- Background: PubMed 16426933Eastwood GM. Evaluating the reliability of recorded fluid balance to approximate body weight change in patients undergoing cardiac surgery. Heart Lung. 2006 Jan-Feb;35(1):27-33. doi: 10.1016/j.hrtlng.2005.06.001.
- Background: PubMed 12853687Mank A, Semin-Goossens A, Lelie Jv, Bakker P, Vos R. Monitoring hyperhydration during high-dose chemotherapy: body weight or fluid balance? Acta Haematol. 2003;109(4):163-8. doi: 10.1159/000070964.
- Background: PubMed 254670Pflaum SS. Investigation of intake-output as a means of assessing body fluid balance. Heart Lung. 1979 May-Jun;8(3):495-8.
- Background: PubMed 18777823Scales K, Pilsworth J. The importance of fluid balance in clinical practice. Nurs Stand. 2008 Jul 30-Aug 5;22(47):50-7; quiz 58, 60. doi: 10.7748/ns2008.07.22.47.50.c6634.
- Derived from this study: PubMed 23635344Bekhof J, van Asperen Y, Brand PL. Usefulness of the fluid balance: a randomised controlled trial in neonates. J Paediatr Child Health. 2013 Jun;49(6):486-92. doi: 10.1111/jpc.12214. Epub 2013 May 2.
Related trials for Very Low Birth Weight Infant
Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Active, not recruiting
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Premature Infant, Respiratory Distress Syndrome in Premature Infant
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
Recruiting
Donor Breast Milk 2
Iron Deficiency Anemia
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.
J Bekhof, pediatrician study director
Princess Amalia Children's Clinic
Y v Asperen, MD principal investigator
University of Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing physician no insight in the fluid balance chart in people with Very Low Birth Weight Infant, run by Princess Amalia Children's Clinic at 1 site in Netherlands.
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 4 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 7 May 2014. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2014). 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?
Duration of Admission at the Ward in Days (time frame: 1-8 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 NCT00962754, which also lists 8 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 7 May 2014.