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.: PACTR202206477083141 Date of Approval: 10/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EVALUATING THE EFFECTS OF SUPPLEMENTING WARD NURSES ON THE QUALITY OF NEWBORN CARE IN KENYAN NEONATAL UNITS
Official scientific title EVALUATING THE EFFECTS OF SUPPLEMENTING WARD NURSES ON THE QUALITY OF NEWBORN CARE IN KENYAN NEONATAL UNITS
Brief summary describing the background and objectives of the trial Adequately staffing hospitals continues to be a challenge in many resource-constrained Low-middle income countries. In these settings, health workers to patient ratios are extreme. The effect of adequate staffing is largely unknown in these settings as research linking hospital staffing and quality of patient care is almost non-existent. The primary aim of this study is to determine the effect of prospectively adding extra nursing staff to newborn units in a resource-constrained setting on the quality of patient care
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Improving quality of patient care
Anticipated trial start date 14/03/2022
Actual trial start date 14/03/2022
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 960
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 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
Experimental Group Adding extra nurses and ward assistants to newborn units Three extra nurses and 2 ward assistants will be added to the existing newborn unit nursing staff of 4 interventional neonatal units The nurses will be added for a period of 1 year while the ward assistants will be added for 6 months Three nurses will be added to the existing nursing staff of 4 intervention newborn units for a one year period. Six months after the addition of the new nurses, 2 ward assistants will be added to each of the units to complement the additional nurses. Across the 4 intervention sites. Observations of care will be carried out on 240 babies at each of baseline, at 6 months after the nurses are added and 6 months after the addition of the ward assistants. 720
Control Group Standard staffing 1 year In the non-intervention arm of this study. No additional nursing staff or ward assistants will be added to the newborn units. A single-time point assessment of observation of care will be carried out on 240 babies across 4 non-intervention hospitals 240 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Sick babies resident in the neonatal unit 2. Those whose parents/caregivers consent to the study 3. Babies on a shift where the nurse on duty has consented to observations 1. Babies who are severely ill and at risk of imminent death during observations of care 2. Babies with congenital anomalies 3. Babies with surgical conditions 4. Those whose parents decline consent New born: 0 Day-1 Month 0 Day(s) 28 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 25/11/2021 Oxford Tropical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Oxford Research Services, University Offices Wellington Square, Oxford Oxford OX1 2JD United Kingdom
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 27/05/2021 KEMRI Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
197 Lenana Place, Off Lenana Road, Nairobi, Kenya. Nairobi 54840-002 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in the magnitude of missed nursing care. Missed nursing care is care that is wholly or partially missed by nurses during the conduct of their duties Baseline, at 6 months and at 12 months after the intervention.
Secondary Outcome Number of vital sign recordings of respiratory rate, pulse rate, temperature and pulse oximetry in the first 48 hours of admission and newborn mortality rate derived from secondarily collected data 12 months before and up to 12 months after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Embu Level 5 hospital Embu - Nairobi Highway Opposite Izaak Walton Hotel Embu Kenya
Kiambu Level 5 hospital Kiambu Road Township Kiambu Kiambu Kenya
Machakos Level 5 hospital Muvuti/Kiima-Kimwe Machakos Wote Road Machakos Kenya
Nyeri County Referral Hospital Plot No 257 Municipality Kimathi Way Nyeri Kenya
Bungoma County Referral Hospital Moi Avenue Township Kanduyi Bungoma Kenya
Kerugoya county referral hospital P.O. Box 24-10300, Kerugoya Kerugoya Kenya
Nakuru Level 5 hospital Lokitang Road, Nakuru Town West, Rift Valley Nakuru Kenya
Thika Level 5 Hospital General Kago Road, Thika Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute for Health Research Guys campus, Kings College London, 4.01 Addison House London SE1 1UL United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford University Offices Wellington Square Oxford OX1 2JD United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
KEMRI Wellcome Trust Research Programme 97 Lenana Place, Off Lenana Road Nairobi 43640 Kenya
University of Oxford University offices, Wellington Square Oxford OX1 2JD United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Abdulazeez Imam abdulazeez.imam@spc.ox.ac.uk +447735292615 Oxford Centre for Global Health Research, Nuffield Department of Medicine, University of Oxford
City Postal code Country Position/Affiliation
Oxford OX1 3SY United Kingdom PhD researcher University of Oxford
Role Name Email Phone Street address
Principal Investigator Mike English menglish@kemri-wellcome.org +447305653484 Oxford Centre for Global Health Research, Nuffield Department of Medicine, University of Oxford
City Postal code Country Position/Affiliation
Oxford OX1 3SY United Kingdom Professor of International Child Health
Role Name Email Phone Street address
Public Enquiries Michuki Maina mmaina@kemri-wellcome.org +254722248890 KEMRI- Wellcome Trust, 197 Lenana Place, off Lenana Road, Kilimani
City Postal code Country Position/Affiliation
Nairobi 43640 Kenya Postdoctoral researcher KEMRI Wellcome trust
Role Name Email Phone Street address
Scientific Enquiries David Gathara david.gathara1@lshtm.ac.uk +254721659321 KEMRI Wellcome Trust, 197 Lenana Place, Lenana Road
City Postal code Country Position/Affiliation
Nairobi 43640 Kenya Assistant Professor London School of Hygiene and Tropical Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the trial will be shared in the form of text, tables, figures and appendices after deidentification Analytic Code,Study Protocol 12 months after study completion Not applicable
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