E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nasopharyngeal suctioning is a painful procedure that often becomes nessecary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is accompanied with multiple side effects these are usually being avoided. In this clinical trial the efficacy of glucose 20% for relieving the procedural pain of nasopharyngeal suctioning is tested. |
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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 |
It is the main objective of the trial to examine whether the oral aplication of Glucose 20% reduces the pain during nasopharyngeal suctioning in preterm infants > 1500g under CPAP-Therapy. The procedure of nasopharyngeal suctioning is recorded on video and the PIPP-Score, a validated pain-score, is used to measure the patient's pain. |
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E.2.2 | Secondary objectives of the trial |
The effectiveness of glucose is also measured by a second pain-score, the VAS. Furthermore heart rate and oxygen saturation are measured and interpreted as physiologic parameters of pain.
As a non-invasive physiologic parameter for the detection of pain and stress the skin conductance will be measured.
Through registration of all AE and SAE the safety of glucose/aqua administration during nasopharyngeal sunctioning is tested. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Preterm newborns (>1500g birth weight) up to a gestational age of 36+6 weeks 2. CPAP respiratory therapy 3. Parents' given written consent |
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E.4 | Principal exclusion criteria |
1. Diseases complicating neuromuscular evaluation. 2. Drug abuse by the mother 3. Administration of other analgetic or sedative drugs within the previous 48h. 4. Participation in another interventional clinical trial within 4 weeks before the beginning of this trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
A 30 % reduction of the pain-score (PIPP) in the group of preterm infants recieving glucose during nasopharyngeal suctioning in comparison to the group recieving aqua. |
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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 | Yes |
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 | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Information not present in EudraCT |
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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The trial ends after the second nasopharyngeal suctioning of the 40th patient included in the study. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |