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NCT Number: NCT06972108

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

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.

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Key information

Conditions

Meconium Aspiration Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Infant, Newborn, Diseases Lung Diseases Lung Injury Pregnancy Complications Respiration Disorders Respiratory Tract Diseases Urogenital Diseases

Age range

10 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caffeine citrate

Drug

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

Primary outcomes

  1. 24 hours oxygenation- 48-72 hours

    Time frame: 48-72 hours before the administration of caffeine or placebo

    24 hours oxygenation (SpO2) at 48-72 hours before the administration of caffeine or placebo

  2. 24 hours oxygenation - 72 hours

    Time frame: 72 hours after the administration of caffeine or placebo

    24 hours oxygenation (SpO2) at 72 hours after the administration of caffeine or placebo

Secondary outcomes

  1. Baseline point-of-care lung ultrasound (POCUS)

    Time frame: At baseline

    Diaphragmatic function and lung aeration scores (0-18, 0=best and 18=worst) via POCUS at baseline

  2. Post randomization Point-of-care lung ultrasound (POCUS)

    Time frame: 60-84 hours after the administration of caffeine or placebo

    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

Other outcomes

  1. Hospital Stay

    Time frame: Up to 10 weeks

    Duration of hospital stay

  2. Duration of respiratory support

    Time frame: Up to 10 weeks

    Respiratory support during the hospital stay

  3. Duration of oxygen therapy

    Time frame: Up to 10 weeks

    Oxygen therapy during the hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Po-Yin Cheung

CONTACT

[email protected]

1-780-716-2818

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Caffeine for Oxygen Dependent Meconium Aspiration Syndrome

Acronym: CAPUCINO

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 14, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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