Preterm BirthNCT07305935
Comparison of Early Caffeine Administration Vs Supportive Therapy in Preventing Acute Kidney Injury
A study testing Caffeine and Supportive care in people with Preterm Birth, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Recent observational data point towards a reduced incidence of acute kidney injury (AKI) with early caffeine use, but high-quality randomized controlled trials comparing early caffeine initiation to supportive therapy alone are lacking. Read more about this study
- Who is it for?
- Ages 1 hour to 6 hours
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Caffeine and Supportive care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates of any gender
- Neonates with gestational age <32 weeks
- Admitted within 6 hours of birth
Who cannot join
- Major congenital anomalies
- Severe birth asphyxia (Apgar <3 at 10 min)
- Pre-existing renal anomalies
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The Children's Hospital & The Institute of Child Health
Multan, Punjab Province, 66000
About this study
Official title: Comparative Efficacy of Early Caffeine Administration Versus Supportive Therapy in Preventing Acute Kidney Injury in Preterm Neonates
Recent observational data point towards a reduced incidence of acute kidney injury (AKI) with early caffeine use, but high-quality randomized controlled trials comparing early caffeine initiation to supportive therapy alone are lacking. This study aims to fill this critical gap by comparing the efficacy of early caffeine administration versus supportive therapy in preventing AKI in preterm neonates.
Read the detailed description
There remains a debate about whether early initiation of caffeine therapy reduces the incidence and severity of AKI in preterm neonates compared to standard supportive care or not. Therefore, the incidence of AKI in preterm neonates will be compared between those receiving early caffeine therapy versus those receiving standard supportive therapy. The findings of this study would not only be a valuable addition to the statistics but also help clinicians to go for a better option in preterm neonates to prevent AKI, resulting in reducing the duration of mechanical ventilation, length of hospital stays, and all-cause neonatal mortality.
- Conditions
- Preterm Birth
- Being tested
- Caffeine, Supportive care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Neonates will receive caffeine citrate (IV or enteral) in 20 mg/kg loading dose within 24 hours of life, followed by a 5 mg/kg/day maintenance dose.
Supportive careDrug
Neonates will be given supportive care without caffeine.
| Study group | Role | What they receive |
|---|---|---|
| Early Caffeine Group | Experimental | Neonates will receive caffeine citrate (IV or enteral) in 20 mg/kg loading dose within 24 hours of life, followed by a 5 mg/kg/day maintenance dose. Receives: Drug: Caffeine |
| Supportive Care Group | Experimental | Neonates will be given supportive care without caffeine Receives: Drug: Supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
Incidence of AKI within the first 14 days of life.
Measured: 14 days
Secondary outcomes (3)
Duration of Acute Kidney Injury
Time duration between onset of AKI and resolution.
Measured: Up to 30 days
Length of Hospital Stay
Time duration from admission to discharge.
Measured: Up to 30 days
Mortality
Mortality will be labelled when a patient expires during a hospital stay.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Oct 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Nazia Fatima, FCPS, Principal investigator, The Children's Hospital & The Institute of Child Health, MultanRabia Saleem, FCPS, Principal investigator, The Children's Hospital & The Institute of Child Health, Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305935
- Sponsor's protocol ID
- DR-NAZIA-MULTAN
- Status last verified
- May 2026
- First submitted
- 5 Dec 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Early Caffeine Administration Versus Supportive Therapy in Preventing Acute Kidney Injury in Preterm Neonates
- ClinicalTrials.gov ID
- NCT07305935
- Acronym / sponsor ID
- DR-NAZIA-MULTAN
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent observational data point towards a reduced incidence of acute kidney injury (AKI) with early caffeine use, but high-quality randomized controlled trials comparing early caffeine initiation to supportive therapy alone are lacking. This study aims to fill this critical gap by comparing the efficacy of early caffeine administration versus supportive therapy in preventing AKI in preterm neonates.
Detailed description
There remains a debate about whether early initiation of caffeine therapy reduces the incidence and severity of AKI in preterm neonates compared to standard supportive care or not. Therefore, the incidence of AKI in preterm neonates will be compared between those receiving early caffeine therapy versus those receiving standard supportive therapy. The findings of this study would not only be a valuable addition to the statistics but also help clinicians to go for a better option in preterm neonates to prevent AKI, resulting in reducing the duration of mechanical ventilation, length of hospital stays, and all-cause neonatal mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Caffeine Group | Experimental | Drug: CaffeineNeonates will receive caffeine citrate (IV or enteral) in 20 mg/kg loading dose within 24 hours of life, followed by a 5 mg/kg/day maintenance dose. |
| Supportive Care Group | Experimental | Drug: Supportive careNeonates will be given supportive care without caffeine |
Who may qualify
- Ages
- 1 hour to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates of any gender
- Neonates with gestational age <32 weeks
- Admitted within 6 hours of birth
Key exclusion criteria (3 listed)
- Major congenital anomalies
- Severe birth asphyxia (Apgar <3 at 10 min)
- Pre-existing renal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaffeineNeonates will receive caffeine citrate (IV or enteral) in 20 mg/kg loading dose within 24 hours of life, followed by a 5 mg/kg/day maintenance dose. | Drug | Early Caffeine Group |
| Supportive careNeonates will be given supportive care without caffeine. | Drug | Supportive Care Group |
Primary outcome
Acute Kidney Injury
Time frame: 14 days
Incidence of AKI within the first 14 days of life.
3 secondary outcomes
Duration of Acute Kidney Injury
Time frame: Up to 30 days
Length of Hospital Stay
Time frame: Up to 30 days
Mortality
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Preterm Birth
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazia Fatima, FCPS principal investigator
The Children's Hospital & The Institute of Child Health, Multan
Rabia Saleem, FCPS principal investigator
The Children's Hospital & The Institute of Child Health, Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine and Supportive care in people with Preterm Birth, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.