Health TrialsbyHealthPanel

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

ConditionsPrematurityRespiratory DiseaseVentilator Lung; Newborn
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

This trial does not accept healthy volunteers

Qualifiers

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

Presented with respiratory distress

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Caffeine citrate

    Drug

    Caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base)

  • Placebo

    Other intervention

    Equivalent volume of saline

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Caffeine citrate groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of respiratory support

cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)

Time frame
28 days

Secondary outcomes

1

Episodes of apnea

the cessation of breathing for more than 20 seconds or cessation of breathing for accompanied by bradycardia or desaturation

Time frame
28 gays
2

Failure of extubation

need of re-intubation within 72 h of extubation from mechanical ventilation

Time frame
28 days
3

Duration of caffeine

Days of caffeine treatment

Time frame
28 days
4

Length of hospital stay

days of hospital admission

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ministry of Health, Saudi Arabia

Lead sponsor

Source ClinicalTrials.gov
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