RecruitingPhase 2Phase 3NCT06026163

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

Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial

Sponsor

Ministry of Health, Saudi Arabia

Enrollment

134 participants

Start Date

Oct 12, 2023

Study Type

INTERVENTIONAL

Conditions

Respiratory Disease Ventilator Lung; Newborn Prematurity

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.

Eligibility

Min Age: 1 DayMax Age: 3 Days

Inclusion Criteria4

Newborn infants at gestational age 34 0/7 through 36 6/7
Presented with respiratory distress
Require respiratory support in the form of any of the following :
A) Invasive mechanical ventilation, B) Non-invasive positive pressure ventilation, C) Nasal cannula with FIO2 requirement over 50% to keep pre-ductal saturation between 90-95%.

Exclusion Criteria3

- Late preterm admitted for non-respiratory etiologies 2- Late preterm infants requiring nasal cannula on less than 50% FIO2 by 4 hours of age as they are less likely to require respiratory support for a long time.
- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with echocardiographic evidence of PPHN requiring medical intervention.
- Late preterm with history of maternal substance abuse

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCaffeine 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)

OTHERPlacebo

Equivalent volume of saline