E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Apnea Of Prematurity |
Apneu's bij prematuriteit |
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E.1.1.1 | Medical condition in easily understood language |
breathing stops because of prematurity |
Ademstops door een onrijpe aansturing van de ademhaling op basis van vroeggeboorte. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to determine if Low-Flow is non inferior in reducing apneic spells compared to caffeine. |
De primaire vraagstelling van deze studie is om te bepalen of Low-Flow non-inferieur is in het reduceren van apneu's in vergelijking met coffeine. |
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E.2.2 | Secondary objectives of the trial |
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. |
Een secundaire vraagstelling van deze studie is het onderzoeken van het gecombineerde effect van Low-Flow en coffeïne in het reduceren van apneu's. Andere secundaire vraagstellingen van deze studie zijn het onderzoeken of deze interventies een effect hebben op de behoefte tot ademhalingsondersteuning en op de duur van opname. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
Prematuren die zijn opgenomen op de neonatologie afdeling zijn includeerbaar indien zij: - geboren zijn tussen AD 32 en 36 weken; - zij stabiel van de CPAP af zijn en - 4 of meer apneu's ervaren in 3 uur óf 4 apneu's ervaren in 12 uur of minder óf 8 apneu's ervaren in 24 uur of minder. |
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E.4 | Principal 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 is required; - If apneic spells are due to other causes of apnea than Apnea of Prematurity, 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; |
- indien andere vormen van ondersteuning/ventilatie/CPAP nodig zijn; - indien de apneu's worden veroorzaakt door secundaire oorzaken (anders dan AOP): infectiologisch, metabool, respiratoir, cardiovasculair, neurologisch, hematologisch, gastro-intestinaal of bijwerkingen door medicatie. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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). |
De primaire uitkomstmaat is therapiefalen. Therapie falen is gedefinieerd als minder dan 50% reductie in apneu's gedurende het onderzoek (gemeten over een periode identiek aan de baseline meetperiode). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
June 2014: start study/recruiting preterm infants. When experiencing the first apneic spell, the infant will be monitored for a baseline period (a minimum period of 3 hours and a maximum period of 24 hours). When meeting the inclusion criteria preterm infants are admitted to the study. The preterm infant will then be monitored over a period identical to the baseline measurement period (again a minimum period of 3 hours and a maximum period of 24 hours), to monitor the effect of the treatment (i.e. the percentage reduction in apneic spells). Therapy for AOP will be continued until it is no longer considered necessary (a maximum of 10 weeks). |
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E.5.2 | Secondary end point(s) |
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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
June 2014: start study/recruiting preterm infants. These end points will be measured at the end of study participation. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Low-Flow met kamerlucht (21% zuurstof) via een neusbril met een flow rate van 1.0 l/min |
Low-Flow with room air (21% oxygen) via nasal cannula at a flow rate of 1.0 l/min |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |