No registrations found.
ID
Source
Brief title
Health condition
Apnea (Dutch: Apneus)
Prematurity (Dutch: Prematuriteit)
Low-Flow (Dutch: Low-Flow)
Caffeine (Dutch: Coffeine)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is treatment failure.
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.
Nature and extent of the burden and risks
Secondary outcome
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.
Study objective
Low-Flow is non-inferior in reducing apneic spells to caffeine.
Study design
-
Intervention
The interventions in this study are Low-Flow and caffeine.
Low-Flow
The study group treated with Low-Flow will receive Low-Flow with room air (21% oxygen), which will be administered via nasal cannula at a flow rate of 1.0 l/min determined using a flow-meter and an oxygen concentration determined with an air/oxygen blender. It will also be heated and humidified.
Caffeine
The study group treated with caffeine will receive a loading dose of caffeine base (10 mg/kg), given orally; then a daily maintenance dose (5 mg/kg) is given orally as per standard practice.
Paediatrician-neonatologist
Departement of Pediatrics
Haaksbergerstraat 55
Enschede 7513 ER
The Netherlands
(053)-4872310
A.kaspers@mst.nl
Paediatrician-neonatologist
Departement of Pediatrics
Haaksbergerstraat 55
Enschede 7513 ER
The Netherlands
(053)-4872310
A.kaspers@mst.nl
Inclusion criteria
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.
Exclusion criteria
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;
- If apneic spells are due to other causes of apneic spells than AOP, such as infection, metabolic disturbances, respiratory compromise, cardiovascular disturbances, central nervous system abnormalities, hematologic imbalance, gastrointestinal abnormalities, disturbance in thermoregulation, or side effects of medication.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4139 |
| NTR-old | NTR4643 |
| Other | NL47657.044.14 : ABR |