Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202110635504187 Date of Approval: 13/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SUBLINGUAL SUGAR FOR THE TREATMENT OF HYPOGLYCEMIA AMONG CHILDREN WITH SEVERE ACUTE MALNUTRITION
Official scientific title THE EFFECT OF SUBLINGUAL SUGAR FOR THE TREATMENT OF HYPOGLYCEMIA AMONG CHILDREN WITH SEVERE ACUTE MALNUTRITION ADIMITTED TO REFFERRAL HOSPITALS IN AMHARA REGION, NORTHWEST ETHIOPIA,2020: A NON-INFERIORITY RANDOMIZED CLINICAL TRIAL
Brief summary describing the background and objectives of the trial Sublingual sugar (SLS) is an alternative approach to the enteral or perenteral drug delivery and is recommended for the treatment of child Hypoglycemia; but evidence is lacking regarding children with Severe-acute malnutrition (SAM) . So the Objective is to assess the patient’s recovery to normal glycemia comparing SLS and glucose intravenous as first line treatment,
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/11/2021
Actual trial start date
Anticipated date of last follow up 31/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group sublingual sugar Ordinary granulated sugar will be used: A teaspoon of sugar (level teaspoon for those under 15 kg, heaped teaspoon for those above that weight, which approximates to 2.5 g and 3.5 g of sugar, respectively) moistened with one or two drops of water. Gently placed under the tongue, repeated every 10 minutes for the first 40 minutes and then every 20 minutes. Two hours. After placing sugar under the tongue, children will be placed in the recovery position to prevent inhalation. Every 10 minutes, the child will be clinically assessed. Family will be advised to inform the nurses to see whether the sugar had been swallowed. If it is the case, this will be recorded and the dose of sublingual sugar will be repeated if no sugar is visible under the tongue. Children who increase their blood glucose concentration (BGC) by 10mg/dl or who remain above hypoglycemia (54mg/dl) in 40 minutes can continue with Sublingual sugar (SLS) . Children who become critical state after 20 minutes or during the course of study will be switched to intravenous glucose (IVG) whatever their glucose level. When the child is able to drink, record the time, check the latest available BGC and then start give 50 ml of 10% glucose or sucrose solution (one rounded teaspoon of sugar in three tablespoons of water) and then start feeding F-75 half an hour after giving glucose and give it every half-hour during the first 2 hours. Then follow the standard feeding protocole. 70
Control Group IVorNG IV dextrose as per hospital current treatment protocol: 5 ml/kg body weight of sterile 10% glucose by IV. If the IVG dose cannot be given immediately, give dose first through NG tube. 2 hours Children in the Control group will receive IV dextrose as per hospital current treatment protocol. In this group, treatment is 5 ml/kg body weight of sterile 10% glucose by IV. If the IVG dose cannot be given immediately, give dose first through NG tube[79]. As in SLS, When the child is able to drink, record the time, check the latest available BGC and then start give 50 ml of 10% glucose or sucrose solution (one rounded teaspoon of sugar in three tablespoons of water) and then start feeding F-75 half an hour after giving glucose and give it every half-hour during the first 2 hours 70 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children admitted to the study hospitals will be eligible if they are --aged 6–59 months, --have Severe Acute Malnutrition --with hypoglycemia (blood glucose concentration (BGC) < 54 mg/dl , < 3 mmol/l), -- are in a condition that would need an IVG or alternative treatment for the same indication: lethargic, unconscious, or convulsing or repeated vomiting; or if they are alert but unable to drink. --and if families or caregivers provide oral and/or written informed consent . Children will be excluded if they are --able to drink properly and do not need IVG. This means children whose blood glucose can be raised through drinking sugary liquid. --have congenital anomalies such as congenital heart disease, physical deformities, --known diabetes, hemophilia or history of neonatal hypoglycemia, --critically ill (such as dying children, children with chock or premortem dyspnea etc) --unable to give blood sample --had been previously enrolled in the study. --have parents or guardians who did not give consent Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/09/2021 Ministry of Science and Higher Education
Ethics Committee Address
Street address City Postal code Country
Front of Ethiopian Aviation Academy addis Abeba 1000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reaching a normal glucose concentration over 60 mg/dl after in 40 minutes. Significant blood glucose gain (> 10 mg/dl) in 40 minutes 40 minutes
Secondary Outcome  Time to normal glycemia: defined as the time to the first normal glycemia  Time to become alert, time to able to drink  Relapse, defined as children who reached a normal glycaemia 3.3 mmol/L (60 mg/dl), but failed to maintain during the study period. Early relapse is before 40 minutes and late relapse between 40 and 120 minutes  Maximal blood glucose concentration (BGC) gain (CGmax), defined as the peak serum glucose concentration within the first line treatment of the first 40 minutes minus the baseline serum glucose concentration  Sustain CGmax defined as the difference between serum glucose concentration at the end of study (2 hours) and the baseline serum glucose concentration  Tolerance and side effects 40 and 120 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Debre Markos referral hospital hospitals location and street 3 Gondar and two others Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Antenna foundation and local facilities Grenade 224 Geneva 1207 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Antenna foundation Grenade 24 Geneva 1207 Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Debre Markos University University street 1 Debre Markos Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aster Tadesse astutadesse84@gmail.com +251581780033 University Street 1
City Postal code Country Position/Affiliation
Gondar 6300 Ethiopia Professor soon to be
Role Name Email Phone Street address
Scientific Enquiries graz bertrand bertrand.graz@unige.ch +41227371240 Grenade 24
City Postal code Country Position/Affiliation
Geneva Switzerland Scientific advisor
Role Name Email Phone Street address
Scientific Enquiries fasil wagnew fasilw.n@gmail.com +251581780033 University street 1
City Postal code Country Position/Affiliation
Debre Markos Ethiopia Scientific and Organisational Supervisor
Role Name Email Phone Street address
Public Enquiries AnneLaure Cavin alcavin@antenna.ch 141227371242 Genade 22
City Postal code Country Position/Affiliation
Geneva Switzerland Scientific followup
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD Will be kept in a safe location in the University hospitals involved in the study. It will be available in an anomymous manner upon request Study Protocol It will be available in an anomymous manner upon request from January 2023 to December 2032 will be accessible to any researchers or reveiwer who might review the data and perhaps perform some new data anlysis, the decision will be in the hands of the Principal investigator and colleagues in University hopitals involved, plus health and ethical authorities following legislation.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information