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

NCT ID: NCT01688674

Last Updated: 2012-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Bolus arm

two hourly dextrose boluses administered via an intravenous cannula

Group Type PLACEBO_COMPARATOR

10% dextrose

Intervention Type DRUG

infusion

10% dextrose infusion by burettes

Group Type EXPERIMENTAL

10% dextrose

Intervention Type DRUG

Interventions

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10% dextrose

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Makerere University

OTHER

Sponsor Role lead

Responsible Party

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KUTAMBA ELIZABETH

Elizabeth Kutamba.R

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mulago Hospital

Kampala, Mulago, Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type DERIVED
PMID: 25352865 (View on PubMed)

Other Identifiers

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2009/HD11/16712 U

Identifier Type: -

Identifier Source: org_study_id