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.: PACTR202004835841980 Date of Approval: 24/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Optimising Nutrition to save the lives of those “Born too soon”
Official scientific title Optimising Nutrition to save the lives of those “born too soon” – a capacity-building collaboration to achieve high-quality newborn care in Kenya and India
Brief summary describing the background and objectives of the trial The United Nations Sustainable Development Goal 3 (UNSDG3), Good Health and Well-Being targets preventable deaths of newborn infants (goals within a goal 3.2) with an aim to reduce neonatal mortality to at least as low as 12 per 1000 live births globally. Prematurity (i.e. infants “born too soon”) is the leading cause of neonatal mortality. According to the WHO, progress in child survival cannot be achieved without addressing prematurity. Premature infants form a third of all those who die within the first month of life. The majority are born in low-and middle-income countries (LMICS); India, with over 3.5 million preterm births, has the largest number. Kenya, with nearly 200,000 preterm births per year is among the countries that account for two thirds of all preterm births globally. More than three-quarters of premature infants can be saved with feasible, cost-effective care which includes optimal feeding and nutrition in the early days of life. There is a lack of good quality evidence to determine the optimal way of feeding preterm infants. This study, therefore, aims to: 1. To investigate the current nutritional care and rate of infection and necrotising enterocolitis in infants “born too soon” in tertiary hospital settings in Kenya and India 2. To explore the opinions of parents, families and health care professionals in determining the priorities for improving care of infants “born too soon” 3. To determine the feasibility of conducting large randomised controlled trials of early feeding interventions in Kenya and India 4. To build research capacity at the partner institutions 5. To assess the effectiveness of the clinical trials training strategy by conducting a before and after methodological study
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/04/2020
Actual trial start date 01/08/2020
Anticipated date of last follow up 03/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status 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 Permuted block randomization Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Full milk feeds 60-80ml/kg/day initially As per clinical requirements based on local guidelines “full milk” – milk feeds will be started at 60-80ml/kg/day volume such that the total fluid requirement of the infant is given as milk. The intention will be to avoid using any IV fluids or parenteral nutrition unless feeds are not tolerated, or IV fluids become indicated for other reasons (e.g. hypoglycaemia). They will continue other IV medication required for ongoing medical care (e.g. antibiotics). 10
Control Group Standard practice Intravenous fluids as per standard practice As per clinical requirements Intravenous fluids transitioning to enteral feeds 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Infant weighing 1000-1800g at birth Be a mother of an infant within 24 hours of birth Be willing and able to provide written consent to take part for the duration of the study - Infants born with congenital anomalies that make enteral feeding unsafe - Infants who are well and ready to be fed full milk feeds as per current guidelines - Infants not likely to survive - Parents not willing to participate in the trial - Infants who are unwell such as those who require prolonged resuscitation, or have severe respiratory distress, or those with hemodynamic instability who cannot tolerate milk feeds as per the attending clinician’s judgement. New born: 0 Day-1 Month 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 28/02/2020 KNH UoN Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Road Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome All outcomes are for feasibility purposes and there are no primary outcome measures. These will be measures of the feasibility of conducting a large RCT related to recruitment, acceptability of randomisation, data collection, and training and support needs for sites. Daily until completion of the study period of 4 months
Secondary Outcome All outcomes are for feasibility purposes and there are no secondary outcome measures. All outcomes are for feasibility purposes and there are no secondary outcome measures.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital Hospital Road Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Nottingham GCRF Optimising Nutrition Project award Building 42 University of Nottingham, Nottingham NG7 2RD Nottingham United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Nairobi Hospital Road Nairobi 00202 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Nottingham Clinical Trials Unit Nottingham Clinical Trials Unit, Building 42 University of Nottingham, NG7 2RD Nottingham United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fred Were Frednwere@gmail.com +254722718770 Hospital Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Professor of Neonatology
Role Name Email Phone Street address
Public Enquiries Fred Were Frednwere@gmail.com +254722718770 Hospital Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Professor of Neonatology
Role Name Email Phone Street address
Scientific Enquiries Jalemba Aluvaala jaluvaala@uonbi.ac.ke +254722217034 Hospital Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Lecturer and Research Fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets analysed during the current study will be available upon request from the Nottingham Clinical Trials Unit (ctu@nottingham.ac.uk), a minimum of six months after publication of the main results paper. Access to the data will be subject to review of a data sharing and use request by a committee including the Chief Investigator, and will only be granted upon receipt of a data sharing and use agreement. Any data shared will be pseudoanonymised which may impact on the reproducibility of published analyses. Study Protocol A minimum of six months after publication of the main results paper Review of a data sharing and use request Data sharing and use agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
ctu@nottingham.ac.uk 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