Caffeine treatment for late preterm infants with breathing difficulties

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of caffeine citrate on late preterm infants experiencing respiratory distress. Infants will be randomly assigned to receive either caffeine or a placebo, with the aim of assessing how caffeine impacts their respiratory support needs, hospital stay duration, and frequency of apnea events. The caffeine treatment group will receive a loading dose followed by a maintenance dose until they no longer require respiratory support. The study is designed to be double-blinded to ensure unbiased results.

Why it matters

Who can join: the full rules

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

Where it's running

• King Salman Bin Abdulaziz Medical City
  Madinah, Medina Region, Saudi Arabia Recruiting
• King Salman Bin Abdulaziz Medical City
  Madinah, Saudi Arabia Recruiting

Study contacts

• Principal investigator: Nehad Nasef — Neonatology Consultant
• Study coordinator: Ohoud Almoualled, Dr
• Email: o.doc2or@gmail.com
• Phone: +966500550679

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.