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Not yet recruiting NCT06972108

CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)

Phase II Interventional Meconium Aspiration Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Caffeine citrate, Saline (NaCl 0,9 %) (placebo).
Who it may be relevant to
Registry conditions: Meconium Aspiration Syndrome. Basic parameters: 10 Days — 14 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Caffeine for Oxygen Dependent Meconium Aspiration Syndrome

Overview

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.

Interventions

  • Drug Caffeine citrate
    Caffeine citrate loading at 10 mg/kg, followed by daily maintenance of 5 mg/kg PO
  • Other Saline (NaCl 0,9 %) (placebo)
    Saline PO for loading and daily maintenance

Primary outcome measures

  • 24 hours oxygenation- 48-72 hours [Time frame: 48-72 hours before the administration of caffeine or placebo]
  • 24 hours oxygenation - 72 hours [Time frame: 72 hours after the administration of caffeine or placebo]
Secondary outcome measures (2)
  • Baseline point-of-care lung ultrasound (POCUS) [Time frame: At baseline]
  • Post randomization Point-of-care lung ultrasound (POCUS) [Time frame: 60-84 hours after the administration of caffeine or placebo]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 38576961

Identifiers

NCT: NCT06972108 · Pro00140244

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗