Reducing breathing spells in preterm infants: air flow versus caffeine
- Conditions
- Apnea (Dutch: Apneus)Prematurity (Dutch: Prematuriteit)Low-Flow (Dutch: Low-Flow)Caffeine (Dutch: Coffeine)
- Registration Number
- NL-OMON20329
- Lead Sponsor
- MST & ZGT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 290
Preterm infants admitted to the department of neonatology are eligible for the study if they are born between 32 and 36 weeks of gestational age, are considered clinically stable off CPAP and if they experience either 4 or more apneic spells in 3 hours; 4 apneic spells in 12 hours or less or 8 apneic spells in 24 hours or less during the first 10 days after birth. The ways of being included will be explained in detail in chapter 8.
In this study an apneic spell is defined as a sudden cessation of breathing lasting for more than 20 seconds or less when associated with either oxygen desaturation (SpO2 <85%) or bradycardia (HR <80 bpm)2.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- If other forms of ventilation or CPAP are required;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is treatment failure. <br /> Treatment failure is defined as less than 50% reduction in apneic spells as measured over a period identical to the baseline measurement period. The minimum baseline duration will be three hours.<br /><br>Nature and extent of the burden and risks
- Secondary Outcome Measures
Name Time Method Secondary objectives are investigating the combined effect of Low-Flow and caffeine in reducing apneic spells and if these treatments have an effect on the need of supplemental ventilation and on the duration of hospitalisation.