Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.NCT01688674
Dextrose Infusion by Burettes Versus Dextrose Boluses in Prevention of Neonatal Hypoglycemia
A study testing 10% dextrose in people with Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period., run by Makerere University at 1 site in Uganda.
Trial summary
NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during the 72 hours of admission in Special Care Unit- Mulago Hospital. Read more about this study
- Who is it for?
- Ages Up to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.
- What is being tested?
- 10% dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUganda
- Study dates
- Feb 2012to Apr 2012
- Phase
- Interventional
- 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 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- SELECTION CRITERIA Inclusion criteria
- Preterms whose care givers/ mothers gave informed consent
- Preterms whose age was < 24 hours of life
- Preterms with birth weight ≥1kg
- Preterms with random blood sugar ≥ 2.6 mmol/l at admission into SCU.
Who cannot join
- Absence of a biological mother or abandoned baby
- Presence of gross congenital abnormalities.
- Very sick (Apgar score ≤ 5 at 5 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dextrose Boluses Versus Dextrose Infusions by Burettes in Prevention of Hypoglycemia Among Preterms Admitted at Mulago Hospital: An Open Label Randomized Clinical Trial
NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during the 72 hours of admission in Special Care Unit- Mulago Hospital.
ALTERNATE HYPOTHESIS
- Use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30% compared to 10% dextrose infusion by burettes among preterms admitted to Special Care Unit in the first 72 hours of admission.
- Conditions
- Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.
- Being tested
- 10% dextrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% dextroseDrug
| Study group | Role | What they receive |
|---|---|---|
| Bolus arm | Placebo comparator | two hourly dextrose boluses administered via an intravenous cannula Receives: Drug: 10% dextrose |
| infusion | Experimental | 10% dextrose infusion by burettes Receives: Drug: 10% dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence proportion of hypoglycemia
Measured: 3months
Secondary outcomes (1)
survival measured as a proportion
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: There was more benefit from the infusion arm compared to the bolus arm.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.Studies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KUTAMBA ELIZABETH, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688674
- Sponsor's protocol ID
- 2009/HD11/16712 U
- Status last verified
- Sep 2012
- First submitted
- 17 Sep 2012
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kutamba E, Lubega S, Mugalu J, Ouma J, Mupere E. Dextrose boluses versus burette dextrose infusions in prevention of hypoglycemia among preterms admitted at Mulago Hospital: an open label randomized clinical trial. Afr Health Sci. 2014 Sep;14(3):502-9. doi: 10.4314/ahs.v14i3.2.
PubMed 25352865
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextrose Boluses Versus Dextrose Infusions by Burettes in Prevention of Hypoglycemia Among Preterms Admitted at Mulago Hospital: An Open Label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01688674
- Acronym / sponsor ID
- 2009/HD11/16712 U
- Conditions
- Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was more benefit from the infusion arm compared to the bolus arm.
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Sep 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.
NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during the 72 hours of admission in Special Care Unit- Mulago Hospital.
ALTERNATE HYPOTHESIS
- Use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30% compared to 10% dextrose infusion by burettes among preterms admitted to Special Care Unit in the first 72 hours of admission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus arm | Placebo comparator | Drug: 10% dextrosetwo hourly dextrose boluses administered via an intravenous cannula |
| infusion | Experimental | Drug: 10% dextrose10% dextrose infusion by burettes |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- SELECTION CRITERIA Inclusion criteria
- Preterms whose care givers/ mothers gave informed consent
- Preterms whose age was < 24 hours of life
- Preterms with birth weight ≥1kg
- Preterms with random blood sugar ≥ 2.6 mmol/l at admission into SCU.
Key exclusion criteria (3 listed)
- Absence of a biological mother or abandoned baby
- Presence of gross congenital abnormalities.
- Very sick (Apgar score ≤ 5 at 5 minutes
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 |
|---|---|---|
| 10% dextrose | Drug | Bolus arm, infusion |
Primary outcome
Incidence proportion of hypoglycemia
Time frame: 3months
1 secondary outcome
survival measured as a proportion
Time frame: 3months
Results and safety
The study was stopped early (reason given: There was more benefit from the infusion arm compared to the bolus arm.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
- Derived from this study: PubMed 25352865Kutamba E, Lubega S, Mugalu J, Ouma J, Mupere E. Dextrose boluses versus burette dextrose infusions in prevention of hypoglycemia among preterms admitted at Mulago Hospital: an open label randomized clinical trial. Afr Health Sci. 2014 Sep;14(3):502-9. doi: 10.4314/ahs.v14i3.2.
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 study testing 10% dextrose in people with Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period., run by Makerere University at 1 site in Uganda.
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 5 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: stopped early, as of the sponsor's last update on 20 Sep 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 Uganda. 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.
Are results available for this study?
The study was stopped early (reason given: There was more benefit from the infusion arm compared to the bolus arm.). 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?
Incidence proportion of hypoglycemia (time frame: 3months). 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 NCT01688674, which also lists 1 linked publication.
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 20 Sep 2012.