The main objective of this study is to determine if Low-Flow is non inferior in reducing apneic spells compared to caffeine. Secondary objectives are investigating if these treatments have an effect on the need of supplemental ventilation and on the…
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
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).
Secondary outcome
A secondary objective of this study is to determine the combined effect of
Low-Flow and caffeine in reducing apneic spells. Other secondary objectives of
this study are to determine the effect of the therapies on the need of
supplemental ventilation and the duration of hospitalisation.
Other study parameters of this study are the use of ventilation before
inclusion and the use of maternal and co-medication during this study.
Background summary
Apnea of prematurity (AOP) is a common clinical development disorder of
respiratory control in preterm infants. Because of this prematurity these
infants sometimes experience a transient cessation of respiration, also called
apnea or apneic spell. Two interventions used in reducing apneic spells in
preterm infants with apnea of prematurity are caffeine and Low-Flow. Both
treatments are common practice and used frequently, separately and sometimes
even simultaneously. There is, however, no evidence which of these treatments
to start first and the choice often varies between the physicians and their
clinical expertise. To our knowledge caffeine therapy has never been compared
to Low-Flow therapy through nasal cannula in preterm infants with AOP.
Study objective
The main objective of this study is to determine if Low-Flow is non inferior in
reducing apneic spells compared to caffeine. Secondary objectives are
investigating if these treatments have an effect on the need of supplemental
ventilation and on the duration of hospitalisation.
Study design
This will be a multicenter, randomized controlled trial.
Intervention
The interventions in this study are Low-Flow and Caffeine.
Fase I:
Group I will receive Low-Flow with heated and humidified room air (21% oxygen),
which will be administered via nasal cannulae at a flow rate of 1.0 l/min.
Group II 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.
Fase II:
If treatment has failed in fase I the infant will move on to fase II and
receive both therapies.
Study burden and risks
The risks of participation are considered minimal. The procedures participants
undergo in this study are not different from regular treatment. The procedures
are anthropometric measurements (height, weight, head circumference), physical
examination (which includes auscultation) and treatment with either Low-Flow
and/or caffeine; all common practices in the neonatal care. For this reason we
believe that the interventions are neither stressfull nor harmfull to this
group of infants. This study is of great therapeutic relevance, because of the
lack of evidence of treatment of first choice for AOP.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
Inclusion criteria
Preterm infants admitted to the department of neonatology are eligible for the study if:
- born between 32 and 36 weeks of gestational age,
- are considered clinically stable, receive no CPAP,
- they experience 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.
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 continues positive airway pressure are required;
- If apneic spells are due to other causes of apnea 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
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2013-005568-24-NL |
| CCMO | NL47657.044.14 |