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

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
10% dextrose
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.

Eligibility Criteria

undefined - 24 Hours (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- 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.

Exclusion Criteria

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

Sites / Locations

  • Mulago Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Bolus arm

infusion

Arm Description

two hourly dextrose boluses administered via an intravenous cannula

10% dextrose infusion by burettes

Outcomes

Primary Outcome Measures

Incidence proportion of hypoglycemia

Secondary Outcome Measures

survival measured as a proportion

Full Information

First Posted
September 17, 2012
Last Updated
September 17, 2012
Sponsor
Makerere University
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1. Study Identification

Unique Protocol Identification Number
NCT01688674
Brief Title
Dextrose Infusion by Burettes Versus Dextrose Boluses in Prevention of Neonatal Hypoglycemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
There was more benefit from the infusion arm compared to the bolus arm.
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makerere University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bolus arm
Arm Type
Placebo Comparator
Arm Description
two hourly dextrose boluses administered via an intravenous cannula
Arm Title
infusion
Arm Type
Experimental
Arm Description
10% dextrose infusion by burettes
Intervention Type
Drug
Intervention Name(s)
10% dextrose
Primary Outcome Measure Information:
Title
Incidence proportion of hypoglycemia
Time Frame
3months
Secondary Outcome Measure Information:
Title
survival measured as a proportion
Time Frame
3months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - 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. Exclusion Criteria Absence of a biological mother or abandoned baby Presence of gross congenital abnormalities. Very sick (Apgar score ≤ 5 at 5 minutes
Facility Information:
Facility Name
Mulago Hospital
City
Kampala
State/Province
Mulago
ZIP/Postal Code
+256
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
25352865
Citation
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.
Results Reference
derived

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

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