Shallow breathing because of prematurity
Conditions
Interventions
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
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.
Sponsors
Medisch Spectrum Twente
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed