Status:
NOT_YET_RECRUITING
CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
Lead Sponsor:
University of Alberta
Conditions:
Meconium Aspiration Syndrome
Eligibility:
All Genders
10-14 years
Phase:
PHASE2
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06972108
Start Date
December 1 2025
End Date
December 31 2027
Last Update
November 18 2025
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