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

September 17, 2012 updated by: KUTAMBA ELIZABETH, Makerere University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
    • Mulago
      • Kampala, Mulago, Uganda, +256
        • Mulago Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Bolus arm
two hourly dextrose boluses administered via an intravenous cannula
Drug: 10% dextrose
EXPERIMENTAL: infusion
10% dextrose infusion by burettes
Drug: 10% dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence proportion of hypoglycemia
Time Frame: 3months
3months

Secondary Outcome Measures

Outcome Measure
Time Frame
survival measured as a proportion
Time Frame: 3months
3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (ESTIMATE)

September 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2012

Last Update Submitted That Met QC Criteria

September 17, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/HD11/16712 U

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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