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.: PACTR201612001867999 Date of Approval: 13/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The use of oral 10% Dextrose for Low Birth Weight newborns in resource poor setting for glycemic control- A Randomized Control Trial
Official scientific title The use of oral 10% Dextrose for Low Birth Weight newborns in resource poor setting for glycemic control- A Randomized Control Trial
Brief summary describing the background and objectives of the trial Over a million babies die due to complications of preterm and low birth weight (LBW), putting it as the second most common cause of death in children under 5 years. Care for preterm/LBW babies can be particularly challenging in resource poor settings where skills and equipment for their care is often lacking. Neonatal hypoglycaemia is a common condition, particularly affecting LBW newborns, and is associated with both acute and long standing complications such as convulsions, neuro-developmental delay and even death. Feeding low birth weight infants can be challenging if there is no breast milk available in the first days of life. These infants are already predisposed to hypoglycemia and thus the risk can be greater if not fed frequently. Ideally, the mother can provide breast milk as soon as possible, however, in many circumstances (poor nutrition of mother, post operative Caesarian section, etc) this may not be the case for hours or even days. If resources are available, this can be managed by providing the LBW neonate with artificial milk whilst waiting for breast milk. However, this is often not available in resource poor countries due to expense and difficulty in production (timely clean safe water, training in how to make the milk etc). Furthermore, in resourced hospitals, glucose is monitored in at risk babies, and should they develop hypoglycemia, IV 10% dextrose can be relatively simply administered. In resource poor settings, this is challenging- firstly, glucose monitoring and then the administration of IV 10% dextrose require resources, skills and nursing that are often not available. The primary aim of this study is to assess whether the use of oral 10% dextrose, is tolerable and reduces the incidence of hypoglycaemia in LBW newborns in the absence of sufficient maternal breast milk. 10% dextrose is readily available, inexpensive and can be stored at room temperature.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Hypoglycemia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 04/01/2016
Actual trial start date 22/02/2016
Anticipated date of last follow up 13/06/2016
Actual Last follow-up date 02/08/2016
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 72
Recruitment status Completed
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 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Breast milk only 2 hourly expressed breast milk (measured) together with breast feeding Until greater than 70% of daily intake achieved Expressed breast milk (measured) together with breast feeding was given to the babies every 2 hours and glucose levels were monitored 36
Experimental Group Oral 10% Dextrose 2 hourly, oral 10% dextrose together with expressed breast milk to calculated ideal requirement 72 hours or Until greater than 70% of daily intake achieved Oral 10% dextrose was added to each 2 hourly feed to make up for any deficiency of expressed breast milk that was calculated as per WHO recommendations. Babies were also allowed to breast feed 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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) 0 Day(s) 1 Day(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 15/04/2016 Tanzania Ethical Approval Committee
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar Es Salaam P.O. Box 11 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hypoglycaemic episode- classified asmoderate (<2.6-1.1 mmol/l) and severe (<1.1mmol/l) During first 72 hours. Measured prefeed at 1 hour 3 hours 5 hours 7 hours then 4 hourly for 48 hours then 6 hourly
Primary Outcome Hypoglycaemic episode- classified asmoderate (<2.6-1.1 mmol/l) and severe (<1.1mmol/l) During first 72 hours. Measured prefeed at 1 hour 3 hours 5 hours 7 hours then 4 hourly for 48 hours then 6 hourly
Secondary Outcome treatment of hypoglycemic episode with oral 10% dextrose 1 hour post hypoglycemic episode and administration of rescue 10% dextrose orally.
Secondary Outcome Body weight difference compared to birth Measured day 4.
Secondary Outcome Episodes of diarrhoea in the first 72 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tosamaganga District Hospital Tosamaganga Hospital Iringa PO BOX 11 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
CUAMM Doctors with Africa Via San Francesco, 126 Padova 35121 Italy
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CUAMM Doctors with Africa Via San Francesco, 126 Padova 35121 Italy Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Sara Chiurchiu Ipamba Hospital Tosamaganga P.O. Box 23447 Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dominik Metz metzdominik@gmail.com +39 049 8751279 Ipamba Hospital
City Postal code Country Position/Affiliation
Iringa S.L.P. 11 Tanzania Paediatrician Doctors with Africa (CUAMM)
Role Name Email Phone Street address
Public Enquiries Dominik Metz metzdominik@gmail.com +39 049 8751279 19 Earlswood Street
City Postal code Country Position/Affiliation
London SE109ET United Kingdom Paediatrician Doctors with Africa (CUAMM)
Role Name Email Phone Street address
Scientific Enquiries Dominik Metz metzdominik@gmail.com +39 049 8751279 19 Earlswood Street
City Postal code Country Position/Affiliation
London SE10 9ET Tanzania Paediatrician Doctors with Africa (CUAMM)
REPORTING
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