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.: PACTR202604505368563 Date of Registration: 24/04/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title High-dose vs. standard-dose caffeine therapy for apnea of prematurity.
Official scientific title High-dose vs. standard dose caffeine therapy for apnea of prematurity: a randomised control trial.
Brief summary describing the background and objectives of the trial Apnea of prematurity (AOP) is a common complication in premature newborns, and caffeine is the recommended methyl xanthine to prevent this complication; however, its optimal dose is not well investigated in low-resource settings. We aimed to compare the efficacy and safety of high-versus standard-dose caffeine on apnoea of prematurity among preterm infants ≤ 34 weeks’ gestation in the perinatal period. General objectives To compare the efficacy and safety of high-dose caffeine citrate (loading dose of 40 mg/kg/day and maintenance of 20 mg/kg/day) versus standard-dose (loading dose of 20 mg/kg/day and maintenance of 10 mg/kg/day) in preventing the occurrence and reducing the frequency of apneas among preterm infants ≤ 34 weeks’ gestation with AOP in the first 7 days of life. Specific Objective To determine the effect of high dose compared to standard dose of caffeine on preventing apnea of prematurity among preterm babies at St. Francis Hospital, Nsambya, and Uganda Martyrs’ Hospital, Lubaga.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HSDC
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 21/10/2025
Actual trial start date 24/10/2025
Anticipated date of last follow up 31/03/2026
Actual Last follow-up date 23/03/2026
Anticipated target sample size (number of participants) 122
Actual target sample size (number of participants) 70
Recruitment status Closed to recruitment,follow-up continuing
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 High dose group Loading dose: 40mg/kg maintenance dose : 20mg/kg First 7 days of life After recruitment, at admission or within the first 24 hours of admission, the high-dose group (experimental group) participants received 40mg/kg of caffeine as a loading dose. Maintenance dosage was initiated on day 2 of admission and continued once daily until the 7th day of admission. The maintenance doses were 20mg/kg/day for the high-dose group. 35
Control Group Standard dose Loading dose: 20mg/kg Maintenance dose: 10mg/kg First 7 days of life. After recruitment, at admission or within the first 24 hours of admission, the standard-dose group(control group) participants received 20mg/kg as a loading dose of caffeine, and a maintenance dosage of 10mg/kg was initiated on day 2 of admission and continued once daily until the 7th day of admission. 35 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Preterm babies with gestational age ≤ 34 weeks by the New Ballard Score. 2. Preterm babies admitted to the Newborn unit at St. Francis Hospital Nsambya and Uganda Martyrs Hospital, Lubaga during the study period. 1. Presence of congenital diaphragmatic hernia or Lung hypoplasia diagnosed prenatally. 2. Participants with a New Ballard score >34 weeks at admission. New born: 0 Day-1 Month 0 Day(s) 7 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 18/08/2025 St. Francis Hospital Nsambya Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Nsambya Road, Hill Kampala 7146 Uganda
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 21/10/2025 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala 6884 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Frequency and severity of apnea episodes. Apnea episodes were documented using standard criteria of the cessation of breathing for more than 20 seconds or the cessation of breathing for less than 20 seconds if it is accompanied by bradycardia (less than 100 beats per minute) or oxygen desaturation (less than 90 %). everyday for the first 7 days of life
Secondary Outcome Adverse events related to caffeine therapy at different dosages everyday , for the first 7 days of life
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St. Francis Hospital Nsambya Nsambya Road, Hill Kampala 7146 Uganda
Uganda Martyrs Hospital Lubaga Muteesa 1 Rd Kampala 14130 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Kyambadde Ronald Seguku Katale Kampala Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kyambadde Ronald seguku Wakiso Uganda Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kyambadde Ronald kyldas93@gmail.com +256755261454 Nsambya Road
City Postal code Country Position/Affiliation
Kampala Uganda Principal investigator
Role Name Email Phone Street address
Public Enquiries Kyambadde Ronald kyldas93@gmail.com +256771931295 Nsambya Road
City Postal code Country Position/Affiliation
Kampala Uganda medical doctor
Role Name Email Phone Street address
Scientific Enquiries Nakibuuka Victoria nakibuukarv@gmail.com +256757369325 Nsambya, Kampala
City Postal code Country Position/Affiliation
Kampala Uganda Neonatologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, data will be shared, and this will include all the participants' data that was collected during the study/trial period. all independent researchers will be able to access the data. Informed Consent Form,Study Protocol Data will be made available between 5 to 9 months after publication. An ongoing randomised clinical trial trial on caffeine therapy for apnea of prematurity.
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
Trial Information Public title 16/04/2026 Guidance by the trial reviewer HIGH DOSE VS STANDARD DOSE CAFFEINE THERAPY FOR APNEA OF PREMATURITY. High-dose vs. standard-dose caffeine therapy for apnea of prematurity.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 16/04/2026 Guidance by the trial reviewer HIGH DOSE VS STANDARD DOSE CAFFEINE THERAPY FOR APNEA OF PREMATURITY: A RANDOMISED CONTROL TRIAL High-dose vs. standard dose caffeine therapy for apnea of prematurity: a randomised control trial.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 16/04/2026 Guidance by the trial reviewer Apnea of prematurity (AOP) is a common complication in premature newborns, and caffeine is the recommended methyl xanthine to prevent this complication; however, its optimal dose is not well investigated in low-resource settings. We aimed to compare the efficacy and safety of high-versus standard-dose caffeine on apnoea of prematurity among preterm infants ≤ 34 weeks’ gestation in the perinatal period. Apnea of prematurity (AOP) is a common complication in premature newborns, and caffeine is the recommended methyl xanthine to prevent this complication; however, its optimal dose is not well investigated in low-resource settings. We aimed to compare the efficacy and safety of high-versus standard-dose caffeine on apnoea of prematurity among preterm infants ≤ 34 weeks’ gestation in the perinatal period. General objectives To compare the efficacy and safety of high-dose caffeine citrate (loading dose of 40 mg/kg/day and maintenance of 20 mg/kg/day) versus standard-dose (loading dose of 20 mg/kg/day and maintenance of 10 mg/kg/day) in preventing the occurrence and reducing the frequency of apneas among preterm infants ≤ 34 weeks’ gestation with AOP in the first 7 days of life. Specific Objective To determine the effect of high dose compared to standard dose of caffeine on preventing apnea of prematurity among preterm babies at St. Francis Hospital, Nsambya, and Uganda Martyrs’ Hospital, Lubaga.
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 16/04/2026 guidance from the reviewer self, Seguku Katale, Kampala, , Uganda, Self Funded, Kyambadde Ronald, Seguku Katale, Kampala, , Uganda, Self Funded,