The use of oral 10% Dextrose for Low Birth Weight newborns in resource poor setting for glycemic control- A Randomized Control Trial

Not Applicable

• Conditions: Paediatrics; Hypoglycemia

• Registration Number: PACTR201612001867999
• Lead Sponsor: CUAMM Doctors with Africa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Neonates in the first day of life satisfying the following inclusion criteria will be eligible to participate in the study:
1. Birth weight <2500 g
2. Parental consent; a written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian before treatment.

Exclusion Criteria

Neonates with any of the below criteria will be excluded from the study
1. Parental refusal to participate to the study
2. Major congenital malformations
3. Birth weight less than 1500 g (VLBW)
4. Signs of significant respiratory distress syndrome (Respiratory Rate >80, grunting)
5. Birth Asphyxia (classified by APGAR score less than 7 at 10 minutes)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypoglycaemic episode- classified asmoderate (<2.6-1.1 mmol/l) and severe (<1.1mmol/l);Hypoglycaemic episode- classified asmoderate (<2.6-1.1 mmol/l) and severe (<1.1mmol/l)

Secondary Outcome Measures

Name	Time	Method
treatment of hypoglycemic episode with oral 10% dextrose;Body weight difference compared to birth;Episodes of diarrhoea