Meconium Aspiration SyndromePhase 2CAPUCINONCT06972108
CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
A Phase 2 study testing Caffeine citrate in people with Meconium Aspiration Syndrome, run by University of Alberta.
Trial summary
When babies are stressed in the womb, they sometimes pass meconium in the amniotic fluid. When this happens, they may swallow the meconium-stained fluid into their lungs which may cause them to have poor oxygen levels and require resuscitation and significant breathing support in the early hours after birth. Read more about this study
- Who is it for?
- Ages 10 to 14 days
- Conditions the study is for
- Meconium Aspiration Syndrome
- What is being tested?
- Caffeine citrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Phase 2
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 10 to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born through meconium-stained amniotic fluid, and
- Gestational age at or greater than 35+0 weeks at birth, and
- Postnatal age of 10 to 14 days-old, and
- Full enteral feeds either at semi-demand with a mix of gavage or oral feeds or at full-demand feeds by oral method, and
- Stable respiratory condition for 24-48 hours prior to enrolment, and require respiratory support defined as: receiving non-invasive respiratory support including one of the following
- High flow nasal cannula of less than or equal to 2L/min/Kg and FiO2 <0.25, or
- Low flow nasal cannula at <100 ml/min
Who cannot join
- Preterm infants of less than 35+0 weeks gestation, or
- Postnatal age younger than 9 day-old or older than 15 day-old, or
- Parenteral nutrition supplementation or full enteral feeds by gavage, or
- Received caffeine within 5 days prior to enrolment, or
- Currently, receiving invasive respiratory support or continuous positive airway pressure (CPAP), or
- During the study period with the administration of study medication, the infant cannot receive steroids including dexamethasone, hydrocortisone and budesonide by intravenous, enteral or inhalational route, or
- Medical diseases including infections, electrolytes or acid-base imbalances, significant anemia, systematic and metabolic disorders that contribute to respiratory insufficiency other than meconium aspiration syndrome, or
- Congenital anomalies including but not limited to respiratory tract malformations, congenital heart diseases, and syndromal abnormalities.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Caffeine for Oxygen Dependent Meconium Aspiration Syndrome
When babies are stressed in the womb, they sometimes pass meconium in the amniotic fluid. When this happens, they may swallow the meconium-stained fluid into their lungs which may cause them to have poor oxygen levels and require resuscitation and significant breathing support in the early hours after birth. This is referred to as Meconium Aspiration Syndrome (MAS). Some babies may recover slowly and require breathing and/or oxygen support for days. Caffeine is a drug that can help improve breathing efforts and is commonly used in premature babies who do not have regular or strong breathing efforts. Caffeine has been used in babies with MAS who recovered slowly (i.e. requiring breathing or oxygen support for a longer period) for several years now. Despite having success in many babies, there is no evidence to examine its effectiveness and mechanism of action. This pilot study proposes to look at the effects of caffeine in babies with MAS who require ongoing breathing and oxygen support. There will also be examination of whether caffeine improves breathing efforts with better lung opening using ultrasound images of the lungs.
- Conditions
- Meconium Aspiration Syndrome
- Being tested
- Caffeine citrate, Saline (NaCl 0,9 %) (placebo)
- Medical subject headings
- Meconium Aspiration Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine citrateDrug
Caffeine citrate loading at 10 mg/kg, followed by daily maintenance of 5 mg/kg PO
Saline (NaCl 0,9 %) (placebo)Other
Saline PO for loading and daily maintenance
| Study group | Role | What they receive |
|---|---|---|
| Caffeine arm | Experimental | Caffeine at standard doses Receives: Drug: Caffeine citrate |
| Placebo arm | Placebo comparator | Not described Receives: Other: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours oxygenation- 48-72 hours
24 hours oxygenation (SpO2) at 48-72 hours before the administration of caffeine or placebo
Measured: 48-72 hours before the administration of caffeine or placebo
24 hours oxygenation - 72 hours
24 hours oxygenation (SpO2) at 72 hours after the administration of caffeine or placebo
Measured: 72 hours after the administration of caffeine or placebo
Secondary outcomes (2)
Baseline point-of-care lung ultrasound (POCUS)
Diaphragmatic function and lung aeration scores (0-18, 0=best and 18=worst) via POCUS at baseline
Measured: At baseline
Post randomization Point-of-care lung ultrasound (POCUS)
Diaphragmatic function and lung aeration scores (0-18, 0=best and 18=worst) via POCUS 60-84 hours after the administration of caffeine or placebo
Measured: 60-84 hours after the administration of caffeine or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meconium Aspiration SyndromeStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972108
- Sponsor's protocol ID
- Pro00140244
- Acronym
- CAPUCINO
- Status last verified
- May 2026
- First submitted
- 21 Apr 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon approval of the researcher group, de-identified individual participant data (IPD) collected in this study available to other researchers. IPD includes individual participant data collected throughout the course of the study and may include the analyzable data set.
Publications
Dini G, Ceccarelli S, Celi F, Semeraro CM, Gorello P, Verrotti A. Meconium aspiration syndrome: from pathophysiology to treatment. Ann Med Surg (Lond). 2024 Feb 15;86(4):2023-2031. doi: 10.1097/MS9.0000000000001835. eCollection 2024 Apr.
PubMed 38576961