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

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201612001867999
• Date of registration: 13/11/2016
• Prospective Registration: No
• Primary sponsor: CUAMM Doctors with Africa
• Public title: The use of oral 10% Dextrose for Low Birth Weight newborns in resource poor setting for glycemic control- A Randomized Control Trial
• Scientific title: The use of oral 10% Dextrose for Low Birth Weight newborns in resource poor setting for glycemic control- A Randomized Control Trial
• Date of first enrolment: 04/01/2016
• Target sample size: 64
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1867
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program,Allocation was determined by the holder of the sequence who is situated off site
• Phase: Not Applicable

Countries of recruitment

Tanzania

Contacts

• Name: Dominik Metz
• Affiliation: Paediatrician Doctors with Africa (CUAMM)

• Name: Dominik Metz
• Affiliation: Paediatrician Doctors with Africa (CUAMM)

Key inclusion & exclusion criteria

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)

Age minimum: 0 Day(s)
Age maximum: 1 Day(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Paediatrics

Paediatrics
Hypoglycemia

Hypoglycemia

Intervention(s)

Breast milk only

Oral 10% Dextrose

Primary Outcome(s)

Hypoglycaemic episode- classified asmoderate (<2.6-1.1 mmol/l) and severe (<1.1mmol/l)

Secondary Outcome(s)

treatment of hypoglycemic episode with oral 10% dextrose

Body weight difference compared to birth

Episodes of diarrhoea

Source(s) of Monetary Support

CUAMM Doctors with Africa

Ethics review

Status: Approved
Approval date: 15/04/2016
Contact:

Tanzania Ethical Approval Committee