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

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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01688674
• Other study ID #: 2009/HD11/16712 U
• Status: Terminated
• Phase: N/A
• First received: September 17, 2012
• Last updated: September 17, 2012
• Start date: February 2012
• Est. completion date: April 2012

Study information

• Verified date: September 2012
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Research Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• 10% dextrose

Locations

Country	Name	City	State
Uganda	Mulago Hospital	Kampala	Mulago

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence proportion of hypoglycemia		3months	No
Secondary	survival measured as a proportion		3months	Yes