Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age1-3
SponsorMinistry of Health, Saudi Arabia

About this trial

Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively.

The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants.

The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.

Eligibility criteria

Qualifiers

Newborn infants at gestational age 34 0/7 through 36 6/7

Presented with respiratory distress

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Caffeine citrate
  • Placebo

Treatment groups

134 Participants
are divided into 2 treatment groups