PrematurityPhase 2/3CAT/LPTNCT06026163
Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
A Phase 2/3 study testing Caffeine citrate in people with Prematurity and Respiratory Disease, run by Ministry of Health, Saudi Arabia at 2 sites in Saudi Arabia.
Trial summary
Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent… Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Prematurity, Respiratory Disease, Ventilator Lung; Newborn
- What is being tested?
- Caffeine citrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 12 Oct 2023to 1 Jan 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn infants at gestational age 34 0/7 through 36 6/7
- Presented with respiratory distress
- Require respiratory support in the form of any of the following :
- Invasive mechanical ventilation, B) Non-invasive positive pressure ventilation, C) Nasal cannula with FIO2 requirement over 50% to keep pre-ductal saturation between 90-95%.
Who cannot join
- 1 - Late preterm admitted for non-respiratory etiologies 2- Late preterm infants requiring nasal cannula on less than 50% FIO2 by 4 hours of age as they are less likely to require respiratory support for a long time.
- 3- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with echocardiographic evidence of PPHN requiring medical intervention.
- 5- Late preterm with history of maternal substance abuse
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King Salman Bin Abdulaziz Medical City
Madinah, Medina Region, 42319
Yasmeen T Aljhani, +966148499629, med-ksamc-irb@moh.gov.sa
Nehad Nasef
- Recruiting
King Salman Bin Abdulaziz Medical City
Madinah
Yasmeen T Aljhani, +966148499629, med-ksamc-irb@moh.gov.sa
About this study
Official title: Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial
Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively.
The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants.
The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.
Read the detailed description
late preterm infants will be randomized in a blinded manner to receive either caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) in Caffeine treatment group, or equivalent volume of saline in the placebo group. Caffeine will be continued until infants get off all forms of respiratory support.
Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.
- Conditions
- Prematurity, Respiratory Disease, Ventilator Lung; Newborn
- Being tested
- Caffeine citrate, Placebo
- Keywords
- caffeine, preterm, newborn, respiratory support
- Medical subject headings
- Premature Birth, Respiration Disorders, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine citrateDrug
Also called Intervention group
Caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base)
PlaceboOther
Also called Saline
Equivalent volume of saline
| Study group | Role | What they receive |
|---|---|---|
| Caffeine citrate group | Experimental | Infants receive either caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base). Receives: Drug: Caffeine citrate |
| Control group | Placebo comparator | Infants received equivalent volume of saline. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of respiratory support
cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)
Measured: 28 days
Secondary outcomes (11)
Episodes of apnea
the cessation of breathing for more than 20 seconds or cessation of breathing for accompanied by bradycardia or desaturation
Measured: 28 gays
Failure of extubation
need of re-intubation within 72 h of extubation from mechanical ventilation
Measured: 28 days
Duration of caffeine
Days of caffeine treatment
Measured: 28 days
Length of hospital stay
days of hospital admission
Measured: 28 days
Time to full enteral and oral feeding
days to reach full enteral feeds
Measured: 28 days
Adverse effects of caffeine use
Tachycardia, irritability, feeding intolerance, hypertension
Measured: 28 days
Caffeine withhold
Caffeine withhold for suspected side effects
Measured: 28 days
Weight gain per day
Weight gain per day (gram)
Measured: 28 days
Mortality
Death before hospital discharge
Measured: 28 days
Readmission rate
Readmission to the hospital with respiratory related symptoms within 48 hours of hospital discharge
Measured: 28 days
Days of apnea
Days of apnea
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start12 Oct 2023
- Primary completion30 Oct 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Saudi Arabia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatema Sulaiman Alhazmi, Ministry of Health, Saudi Arabia
- Investigators
- Nehad Nasef, Principal investigator, Neonatology Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026163
- Sponsor's protocol ID
- H-09-M-11
- Acronym
- CAT/LPT
- Status last verified
- Jun 2025
- First submitted
- 27 Aug 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers for research and scientific purposes (i.e conduction of meta-analysis or systematic review). Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Davis PG, Schmidt B, Roberts RS, Doyle LW, Asztalos E, Haslam R, Sinha S, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine for Apnea of Prematurity trial: benefits may vary in subgroups. J Pediatr. 2010 Mar;156(3):382-7. doi: 10.1016/j.jpeds.2009.09.069. Epub 2009 Nov 18.
PubMed 19926098Eichenwald EC; Committee on Fetus and Newborn, American Academy of Pediatrics. Apnea of Prematurity. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-3757. Epub 2015 Dec 1.
PubMed 26628729
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06026163
- Acronym / sponsor ID
- CAT/LPT / H-09-M-11
- Conditions
- Prematurity, Respiratory Disease, Ventilator Lung; Newborn
- Keywords
- caffeine, preterm, newborn, respiratory support
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 6 Sep 2023 (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.
Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively.
The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants.
The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.
Detailed description
late preterm infants will be randomized in a blinded manner to receive either caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) in Caffeine treatment group, or equivalent volume of saline in the placebo group. Caffeine will be continued until infants get off all forms of respiratory support.
Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine citrate group | Experimental | Drug: Caffeine citrateInfants receive either caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base). |
| Control group | Placebo comparator | Other: PlaceboInfants received equivalent volume of saline. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborn infants at gestational age 34 0/7 through 36 6/7
- Presented with respiratory distress
- Require respiratory support in the form of any of the following :
- Invasive mechanical ventilation, B) Non-invasive positive pressure ventilation, C) Nasal cannula with FIO2 requirement over 50% to keep pre-ductal saturation between 90-95%.
Key exclusion criteria (3 listed)
- 1 - Late preterm admitted for non-respiratory etiologies 2- Late preterm infants requiring nasal cannula on less than 50% FIO2 by 4 hours of age as they are less likely to require respiratory support for a long time.
- 3- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with echocardiographic evidence of PPHN requiring medical intervention.
- 5- Late preterm with history of maternal substance abuse
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 |
|---|---|---|
| Caffeine citrateAlso: Intervention groupCaffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) | Drug | Caffeine citrate group |
| PlaceboAlso: SalineEquivalent volume of saline | Other | Control group |
Primary outcome
Duration of respiratory support
Time frame: 28 days
cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)
11 secondary outcomes
Episodes of apnea
Time frame: 28 gays
Failure of extubation
Time frame: 28 days
Duration of caffeine
Time frame: 28 days
Length of hospital stay
Time frame: 28 days
Time to full enteral and oral feeding
Time frame: 28 days
Adverse effects of caffeine use
Time frame: 28 days
Caffeine withhold
Time frame: 28 days
Weight gain per day
Time frame: 28 days
Mortality
Time frame: 28 days
Readmission rate
Time frame: 28 days
Days of apnea
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Background: PubMed 19926098Davis PG, Schmidt B, Roberts RS, Doyle LW, Asztalos E, Haslam R, Sinha S, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine for Apnea of Prematurity trial: benefits may vary in subgroups. J Pediatr. 2010 Mar;156(3):382-7. doi: 10.1016/j.jpeds.2009.09.069. Epub 2009 Nov 18.
- Background: PubMed 26628729Eichenwald EC; Committee on Fetus and Newborn, American Academy of Pediatrics. Apnea of Prematurity. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-3757. Epub 2015 Dec 1.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers for research and scientific purposes (i.e conduction of meta-analysis or systematic review). Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Nehad Nasef principal investigator
Neonatology Consultant
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Caffeine citrate in people with Prematurity and Respiratory Disease, run by Ministry of Health, Saudi Arabia at 2 sites in Saudi Arabia.
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 4 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: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ohoud Almoualled, Dr (+966500550679, o.doc2or@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of respiratory support (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06026163, which also lists 2 linked publications.
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 27 Jun 2025.