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

Makerere University

Status: Terminated

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

Treatments: Drug: 10% dextrose

Study type: Interventional

Funder types: Other

Identifiers

NCT01688674

2009/HD11/16712 U

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: Under 24 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups, including a placebo group

Bolus arm

Placebo Comparator group

Description:

two hourly dextrose boluses administered via an intravenous cannula

Treatment:

Drug: 10% dextrose

infusion

Experimental group

Description:

10% dextrose infusion by burettes

Treatment:

Drug: 10% dextrose