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

NCT06026163 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Prematurity
  • Respiratory Disease
  • Ventilator Lung; Newborn

Interventions

DRUG

Caffeine citrate

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)

OTHER

Placebo

Equivalent volume of saline

Sponsors & Collaborators

  • Ministry of Health, Saudi Arabia

    lead OTHER_GOV

Principal Investigators

  • Nehad Nasef · Neonatology Consultant

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-12
Primary Completion
2027-10-30
Completion
2028-01-01

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06026163 on ClinicalTrials.gov