NCT01688674

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

September 17, 2012

Last Update Submit

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Mulago Hospital

Kampala, Mulago, +256, Uganda

Location

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

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 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 20, 2012

Record last verified: 2012-09

Locations

UG(1)