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NCT Number: NCT06026163

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Intervention group

Placebo

Other

Equivalent volume of saline

Other names: Saline

Primary outcomes

  1. Duration of respiratory support

    Time frame: 28 days

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

Secondary outcomes

  1. Episodes of apnea

    Time frame: 28 gays

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

  2. Failure of extubation

    Time frame: 28 days

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

  3. Duration of caffeine

    Time frame: 28 days

    Days of caffeine treatment

  4. Length of hospital stay

    Time frame: 28 days

    days of hospital admission

  5. Time to full enteral and oral feeding

    Time frame: 28 days

    days to reach full enteral feeds

  6. Adverse effects of caffeine use

    Time frame: 28 days

    Tachycardia, irritability, feeding intolerance, hypertension

  7. Caffeine withhold

    Time frame: 28 days

    Caffeine withhold for suspected side effects

  8. Weight gain per day

    Time frame: 28 days

    Weight gain per day (gram)

  9. Mortality

    Time frame: 28 days

    Death before hospital discharge

  10. Readmission rate

    Time frame: 28 days

    Readmission to the hospital with respiratory related symptoms within 48 hours of hospital discharge

  11. Days of apnea

    Time frame: 28 days

    Days of apnea

Study contacts

Contact information is provided by the study sponsor or research team.

Ohoud Almoualled, Dr

CONTACT

[email protected]

+966500550679

Sponsors and collaborators

Lead sponsor

Ministry of Health, Saudi Arabia

Other Gov

Registry information

Official study title

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

Acronym: CAT/LPT

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Sep 6, 2023
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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