Clinical trial NCT06972108: CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
Official title: Caffeine for Oxygen Dependent Meconium Aspiration Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Meconium Aspiration Syndrome
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. Infants born through meconium-stained amniotic fluid, and
2. Gestational age at or greater than 35+0 weeks at birth, and
3. Postnatal age of 10 to 14 days-old, and
4. Full enteral feeds either at semi-demand with a mix of gavage or oral feeds or at full-demand feeds by oral method, and
5. 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

   1. High flow nasal cannula of less than or equal to 2L/min/Kg and FiO2 \<0.25, or
   2. Low flow nasal cannula at \<100 ml/min

Exclusion Criteria:

1. Preterm infants of less than 35+0 weeks gestation, or
2. Postnatal age younger than 9 day-old or older than 15 day-old, or
3. Parenteral nutrition supplementation or full enteral feeds by gavage, or
4. Received caffeine within 5 days prior to enrolment, or
5. Currently, receiving invasive respiratory support or continuous positive airway pressure (CPAP), or
6. 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
7. 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
8. Congenital anomalies including but not limited to respiratory tract malformations, congenital heart diseases, and syndromal abnormalities.

Primary outcomes:
measure: 24 hours oxygenation- 48-72 hours
timeFrame: 48-72 hours before the administration of caffeine or placebo
measure: 24 hours oxygenation - 72 hours
timeFrame: 72 hours after the administration of caffeine or placebo
Secondary outcomes:
measure: Baseline point-of-care lung ultrasound (POCUS)
timeFrame: At baseline
measure: Post randomization Point-of-care lung ultrasound (POCUS)
timeFrame: 60-84 hours after the administration of caffeine or placebo
Other outcomes:
measure: Hospital Stay
timeFrame: Up to 10 weeks
measure: Duration of respiratory support
timeFrame: Up to 10 weeks
measure: Duration of oxygen therapy
timeFrame: Up to 10 weeks
Locations:
Study officials:
References:
citation: 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.