NCT01688674

Terminated

Dextrose Infusion by Burettes Versus Dextrose Boluses in Pre...

Makerere University Source

Makerere University

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

2009/HD11/16712 U

Study Type

interventional

Actual enrollment (reported)

140

Locations

1 country

Sites

1

Timeline

Study Start

February 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2012

Actual (reported)

Study Completion

April 2012

Actual (reported)

Brief 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. 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 140 participants
Study completion date: April 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)
Study Completion
April 2012
Actual (reported)
First Submitted
September 17, 2012
Actual (reported)
First Posted
September 20, 2012
Actual (reported)

Last Updated: September 20, 2012
Status Verified: September 2012
Last Update Submitted: September 17, 2012

Conditions

Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.

Outcome Measures

Primary Outcomes (1)

Incidence proportion of hypoglycemia
3months

Secondary Outcomes (1)

survival measured as a proportion
3months

Study Arms (2)

Bolus arm

PLACEBO COMPARATOR

two hourly dextrose boluses administered via an intravenous cannula

Drug: 10% dextrose

infusion

EXPERIMENTAL

10% dextrose infusion by burettes

Drug: 10% dextrose

Interventions

10% dextroseDrug

Bolus arminfusion

Eligibility Criteria

AgeUp to 24 Hours

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Preterms whose care givers/ mothers gave informed consent
Preterms whose age was \< 24 hours of life

Sponsors & Collaborators

Makerere University
Otherlead

Study Sites (1)

Mulago Hospital

Kampala, Mulago, +256, Uganda

Related Publications (1)

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.
PMID: 25352865DERIVED

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Enrollment

140 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Elizabeth Kutamba.R

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 20, 2012

Study Start

February 2012

Date type not reported

This date has not been verified as actual or estimated.

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Phase 4Completed

Preterms with birth weight ≥1kg

Preterms with random blood sugar ≥ 2.6 mmol/l at admission into SCU.

You may not qualify if:

Absence of a biological mother or abandoned baby
Presence of gross congenital abnormalities.
Very sick (Apgar score ≤ 5 at 5 minutes

Contact the study team to confirm eligibility.

Primary Completion

April 2012

Actual (reported)

Study Completion

April 2012

Actual (reported)

Last Updated

September 20, 2012

Record last verified: 2012-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01688674
Data provider: ClinicalTrials.gov
Source updated: 2012-09-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:34 UTC

Locations

UG(1)

Study Stopped

Dextrose Infusion by Burettes Versus Dextrose Boluses in Prevention of Neonatal Hypoglycemia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Bolus arm

infusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Bolus arm

infusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations