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.: PACTR201810856025709 Date of Approval: 03/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTS OF EARLY ENTERAL FEEDS WITH MOTHERS’ MILK AMONG VERY LOW BIRTH WEIGHT AND CRITICALLY ILL NEONATES ADMITTED AT REGIONAL HOSPITALS IN DAR ES SALAAM
Official scientific title EFFECTS OF EARLY ENTERAL FEEDS WITH MOTHERS’ MILK AMONG VERY LOW BIRTH WEIGHT AND CRITICALLY ILL NEONATES ADMITTED AT REGIONAL HOSPITALS IN DAR ES SALAAM
Brief summary describing the background and objectives of the trial Background: Early enteral feeding in neonates is usually delayed in very low birth weight (VLBW) and critically ill neonates in the regional hospitaals of Dar es Salaam due to unstable haemodynamics and the risk of necrotizing enterocolitis (NEC). This prevents these neonates from receiving beneficial effects of colostrum hence predisposing them to various health problems including increase risk of infections, poor growth and development and even mortality. Minimal enteral feeding (MEN) and oral mucosa colostrum (OMC) administration are other feeding options available and can be used safely among unstable neonates. But these methods are not utilized in most of neonatal intensive care units (NICU) leading to delayed feeding among unstable neonates which further increase the risk of mortality and morbidity. Broad objective: To determine effects of early enteral feeding using mother’s milk on neonatal outcomes compared to nil orally standard feeding practices amongst VLBW and critically ill neonates admitted at regional hospitals in Dar es Salaam
Type of trial CCT
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 01/10/2018
Actual trial start date 07/10/2018
Anticipated date of last follow up 31/03/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 260
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 Non-randomised 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 usual delayed feeding not applicable observation during neonatal period (28 days) or until discharge from hospital, which ever event is occurring first data collection of patients who do not receive any intervention and will be treated by the attending clinicians and nurses according to their standards 130 Historical
Experimental Group early enteral feeding 3 hourly mother milk feeding according to days of life and body weight Neonatal period (28 days) or discharge from hospital, which ever is occurring first standardized feeding guidelines will be applied according to study protocol neonates will receive either enteral feeding or oral colostrum swabbing on first day of life and then feeding will be gradually increased according to international standards 130
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Neonates with very low birth weight (VLBW) Neonates with moderate to severe birth asphyxia using the Thompson score for HIE Major congenital malformation Mother HIV infected and opting against breastfeeding Admitted to neonatal ward beyond the first 24 hours New born: 0 Day-1 Month 0 Day(s) 1 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 29/08/2018 Muhimbili University of Health and Allied Sciences MUHAS Institutional review board
Ethics Committee Address
Street address City Postal code Country
P.O.Box 65001 Dar es Salaam 65001 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of necrotizing enterocolitis within the neonatal period of 28 days
Secondary Outcome Neonatal mortality rate during neonatal period of 28 days
Secondary Outcome Duration until birth weight is regained neonatal period of 28 days
Secondary Outcome Duration until full enteral mothers milk feeding is reached neonatal period of 28 days
Secondary Outcome Duration of hospital stay neonatal period of 28 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Temeke Regional Referral Hospital P.O.Box 45232 Dar es Salaam Tanzania
Amana Regional Referral Hospital P.O.Box 25411 Dar es Salaam Tanzania
Mwananyamala Regional Referral Hospital P.O.Box 61665 Dar es Salaam Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Laerdal foundation Tanke Svilandgst. 30 Stavanger 4007 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CCBRT P.O.Box 23310 Dar es Salaam Tanzania Hospital
COLLABORATORS
Name Street address City Postal code Country
Regina Hyera P.O.Box 65001 Dar es Salaam Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Regina Hyera hyeraregina@gmail.com +255767865531 P.O.Box 65001
City Postal code Country Position/Affiliation
Dar es Salaam Tanzania Postgraduate student MUHAS
Role Name Email Phone Street address
Public Enquiries Antke Zuechner antke.zuechner@ccbrt.org +255785568916 P.O.Box 23310
City Postal code Country Position/Affiliation
Dar es Salaam Tanzania Neonatologist CCBRT
Role Name Email Phone Street address
Scientific Enquiries Germana Leyna gerryleyna@yahoo.com +255782847320 P.O.B 65001
City Postal code Country Position/Affiliation
Dar es Salaam Tanzania Epidemiologist MUHAS
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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