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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10-14
SponsorUniversity of Alberta

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Caffeine citrate
  • Saline (NaCl 0,9 %) (placebo)

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators