Could caffeine help newborns with lung problems breathe easier?
NCT ID NCT06972108
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether caffeine can improve breathing in newborns with meconium aspiration syndrome, a condition where babies inhale their first stool into their lungs. Twenty babies who still need oxygen support at 10-14 days old will receive either caffeine or a placebo. Researchers will measure oxygen levels and use lung ultrasound to see if caffeine helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- caffeine citrate
- What this could lead to
- If it works, this could provide a simple, low-cost treatment to help newborns with meconium aspiration syndrome breathe easier and reduce their need for oxygen support.
- What could go wrong
- This is a very small pilot study with only 20 babies, so results may not be conclusive. Caffeine is generally safe but can cause side effects like jitteriness or fast heart rate in newborns.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 14 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
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A doctor treating you
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