Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress (CAT/LPT)

Ministry of Health, Saudi Arabia

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Prematurity; Respiratory Disease; Ventilator Lung; Newborn

Treatments: Other: Placebo; Drug: Caffeine citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT06026163

H-09-M-11

Details and patient eligibility

About

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.

Full description

late preterm infants will be randomized in a blinded manner to receive either caffeine 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) in Caffeine treatment group, or equivalent volume of saline in the placebo group. Caffeine will be continued until infants get off all forms of respiratory support.

Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.

Enrollment: 134 estimated patients

Sex: All

Ages: 1 to 3 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

1 - 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.

3- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with echocardiographic evidence of PPHN requiring medical intervention.

5- Late preterm with history of maternal substance abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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134 participants in 2 patient groups, including a placebo group

Caffeine citrate group

Experimental group

Description:

Infants receive either 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).

Treatment:

Drug: Caffeine citrate

Control group

Placebo Comparator group

Description:

Infants received equivalent volume of saline.

Treatment:

Other: Placebo