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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202502489638730 Date of Registration: 24/02/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PRETERM AFRICA STUDY
Official scientific title Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa
Brief summary describing the background and objectives of the trial Background: Respiratory distress syndrome is a leading cause of preterm deaths in low- and middle-income countries. Interventions such as continuous positive airway pressure (CPAP), caffeine citrate, and surfactant administered through less invasive techniques have been shown to improve respiratory distress and survival in high-income counties but have not been critically evaluated in LMICs. The trial objective is to determine the effect of implementing a standardized low-cost CPAP device, caffeine citrate, and surfactant administered through the Less Invasive Surfactant Administration (LISA) technique on preterm survival in SSA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PRETERM AFRICA STUDY
Disease(s) or condition(s) being studied Neonatal Diseases,Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2025
Actual trial start date 01/01/2025
Anticipated date of last follow up 01/11/2027
Actual Last follow-up date 31/01/2028
Anticipated target sample size (number of participants) 1512
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 Simple randomization using a randomization table created by a computer software program Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Vayu Bubble CPAP and Caffeine Citrate 1. CPAP between 5 and 8 cmH2O 2. Caffeine citrate: Loading dose of 20 mg/kg and maintenance dose of 10 mg/kg 1. CPAP: Until respiratory distress resolves as determined by the Silverman Anderson Score 2. Caffeine Citrate: At least the first two weeks of life or until the signs of apnea of prematurity resolve. 1. The Vayu bubble CPAP is a low-cost device that delivers humidified, filtered, pressurized, and oxygen-enriched air to the patient. The Vayu bCPAP utilizes a novel venturi oxygen blender that can adjust the fraction of inspired oxygen between 30 and 100% 2. Caffeine citrate is a methylxanthine used to treat apnea of prematurity. 756 Active-Treatment of Control Group
Experimental Group Vayu Bubble CPAP. Caffeine Citrate. Less Invasive Surfactant Administration 1. CPAP between 5 and 8 cmH2O 2. Caffeine citrate: Loading dose of 20 mg/kg and maintenance dose of 10 mg/kg 3. BLES surfactant: 5 ml/kg (at 27mg of phospholipids/mL, which equals 135mg phospholipid/kg) 1. CPAP: Until resolution of respiratory distress as determined by the Silverman Anderson Score. 2. Caffeine citrate: For at least the first two weeks of life or until the resolution of apnea of prematurity. 3. BLES surfactant: One time dose. 1. Vayu bubble CPAP: The Vayu bubble CPAP is a low-cost device that delivers humidified, filtered, pressurized, and oxygen-enriched air to the patient. he Vayu bCPAP utilizes a novel venturi oxygen blender that can adjust the fraction of inspired oxygen between 30 and 100% 2. Caffeine citrate is a methylxanthine used to treat apnea of prematurity. 3. BLES surfactant is a suspension of 27mg phospholipid/mL 756
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks. 2. Silverman Anderson Score ≥5 before or after CPAP treatment. 3. Admitted to a study site within 24 hours of life. 4. Parents provide written informed consent. 1. Major congenital or genetic anomalies. 2. Active pulmonary hemorrhage. 3. Major craniofacial anomalies that preclude the successful use of CPAP. 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
No 16/02/2024 Indiana University Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
509 E 3rd Street Bloomington 47401 United States of America
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 05/11/2024 Tamale Teaching Hospital Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Salaga Yendi Road Tamale 11111 Ghana
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 15/12/2024 Korle Bu Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Guggisberg Ave Accra 11111 Ghana
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 24/07/2024 Human Research and Ethics Committee Federal Teaching Hospital Ido Ekiti
Ethics Committee Address
Street address City Postal code Country
Ifaki Ido Road Ido-Ekiti 11111 Nigeria
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 14/02/2025 The Aga Khan University Nairobi Institutional Scientific and Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue Nairobi 11111 Kenya
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 14/08/2024 UITH Ethical Research Committee
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road Ilorin 11111 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 28/10/2024 Konfo Anokye Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Okomfo Anokye Road Kumasi 11111 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 04/12/2024 Comite Scientifique de Validation des Protocoles et Resultats de la Recherche en Sante
Ethics Committee Address
Street address City Postal code Country
Avenue des Martyrs Bangui 11111 Central African Republic
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Survival At hospital disposition: Death or discharge
Secondary Outcome Survival at 72 hours of life 72 hours of life
Secondary Outcome The incidence of major complications of prematurity including retinopathy of prematurity, neonatal sepsis, intracranial hemorrhage, necrotizing enterocolitis, bronchopulmonary dysplasia, and pneumothorax. At hospital disposition: Death or discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre Hospitalier Universitaire Communautaire 1st district of Bangui Bangui Central African Republic
Korle Bu Teaching Hospital Guggisberg Ave Accra Ghana
Komfo Anokye Teaching Hospital Okomfo Anokye Road Kumasi Ghana
Tamale Teaching Hospital Salaga Yendi Rd Tamale Ghana
Mama Lucy Kibaki Hospital Kangundo Road Umoja Nairobi Kenya
Coast Provincial General Hospital Kisauni Road Mombasa Kenya
Federal Teaching Hospital Ido Ekiti Ifaki Ido Road Ido Ekiti Nigeria
University of Ilorin Teaching Hospital Old Jeba Road Illorin Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Open Philanthropy 182 Howard Street 225 San Francisco 94105 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Indiana University Office for Research Administration 509 E 3rd Street Bloomington 47401 United States of America University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Osayame Ekhaguere osaekhag@iu.edu +2347088410529 1030 West Michigan Street
City Postal code Country Position/Affiliation
Indianapolis 46202 United States of America Assistant Professor
Role Name Email Phone Street address
Public Enquiries Olufunke Bolaji olufunke.bolaji@gmail.com +2347081007368 Federal Teaching Hospital
City Postal code Country Position/Affiliation
Ido Ekiti Nigeria Consultant Paediatrician
Role Name Email Phone Street address
Scientific Enquiries Helen Nabwera helen.nabwera@aku.edu +447900926893 3rd Parklands Ave
City Postal code Country Position/Affiliation
Nairobi Kenya Associate Professor
Role Name Email Phone Street address
Public Enquiries Naana Wireko Brobby mayiwah@yahoo.com +233550348764 Okomfo Anokye Road
City Postal code Country Position/Affiliation
Kumasi Ghana Consultant neonatologist
Role Name Email Phone Street address
Public Enquiries Synthia Ningatoloum cynthinaz@yahoo.fr +23675758227 1st district of Bangui
City Postal code Country Position/Affiliation
Bangui Central African Republic Consultant Pediatrician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices). Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 9 months and ending 36 months following publication Investigators whose proposed use of the data has been approved by an institutional review committee of the individual institutions of the participating site.
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
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 21/02/2025 In response to query Public Enquiries, Naana , Wireko Brobby, Dr., mayiwah@yahoo.com, , +233550348764, Okomfo Anokye Road, Kumasi, 11111, Ghana, Consultant neonatologist
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 21/02/2025 In response to query Public Enquiries, Naana , Wireko Brobby, Dr., mayiwah@yahoo.com, , +233550348764, Okomfo Anokye Road, Kumasi, 11111, Ghana, Consultant neonatologist Public Enquiries, Naana , Wireko Brobby, Dr., mayiwah@yahoo.com, , +233550348764, Okomfo Anokye Road, Kumasi, , Ghana, Consultant neonatologist
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 21/02/2025 In response to query Public Enquiries, Synthia, Ningatoloum, Dr., cynthinaz@yahoo.fr, , +23675758227, 1st district of Bangui, Bangui , , Central African Republic, Consultant Pediatrician