|- candidate number||18088|
|- NTR Number||NTR4643|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jun-2014|
|- Secondary IDs||ABR NL47657.044.14|
|- Public Title||Reducing breathing spells in preterm infants: air flow versus caffeine|
|- Scientific Title||Reducing Apneas in Preterm Infants:
Low-Flow versus Caffeine|
|- hypothesis||Low-Flow is non-inferior in reducing apneic spells to caffeine.|
|- Healt Condition(s) or Problem(s) studied||Prematurity, Apnea|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||10-jun-2014|
|- planned closingdate||1-jun-2017|
|- Target number of participants||290|
|- Interventions||The interventions in this study are Low-Flow and caffeine.
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.
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.
|- 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.|
|- Trial web site||-|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Mw. drs. A.G. Kaspers|
|- CONTACT for SCIENTIFIC QUERIES||Mw. drs. A.G. Kaspers|
|- Sponsor/Initiator ||Medisch Spectrum Twente, Ziekenhuisgroep Twente|
(Source(s) of Monetary or Material Support)
|Stichting Pediatric Research Enschede|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||11-jun-2014 - 26-jul-2014|