Avoid Mechanical Ventilation: The AMV-trial
| ISRCTN | ISRCTN05025922 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05025922 |
| EudraCT/CTIS number | 2006-006912-31 |
| Secondary identifying numbers | AMV-12_12_2006 Vers. 2 |
- Submission date
- 27/09/2007
- Registration date
- 15/11/2007
- Last edited
- 20/12/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Wolfgang Gopel
Scientific
Scientific
Universitatsklinikum Schleswig-Holstein
Ratzeburger Allee 160
Kinderklinik
Lubeck
D-23538
Germany
| goepel@paedia.ukl.mu-luebeck.de |
Study information
| Study design | Prospective, interventional, randomised controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | AMV |
| Study objectives | The primary objective of this study is to demonstrate that the treatment of preterm infants with intratracheal instillation of surfactant shortly before an expected intubation is able to reduce the frequency of mechanical ventilation. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee (Ethikkommission der medizinischen Fakultat der Universitat Lubeck) on the 3rd July 2007 (ref: 07-037). |
| Health condition(s) or problem(s) studied | Respiratory distress syndrome of preterm infants |
| Intervention | Please note that as of 25/08/10 the patient enrollment phase of this trial has been completed. Intervention: Surfactant is given at a dose of 100 mg surfactant per kg body weight via a thin gastric tube into the trachea of the spontaneously breathing infants. Surfactant without intubation will be given as a single dose at the first day of life. Repeated surfactant treatment without intubation is possible until the third day of life. Control group: Standard care. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Surfactant |
| Primary outcome measure | The primary outcome is a combined parameter which is measured between the 25th and 72nd hour of life (day 2 and 3 of life). The primary endpoint is positive if an infant is: 1. Intubated and ventilated between the 25th and the 72nd hour of life 2. Fraction of inspired Oxygen (FiO2) is greater than 0.6 for more than two hours between the 25th and the 72nd hour of life (to keep oxygen saturation above 85%) 3. Partial pressure of Carbon Dioxide (pCO2) greater than 65 mmHg for more than two hours between the 25th and 72nd hour of life |
| Secondary outcome measures | 1. Ventilation rate 2. Intraventricular Haemorrhage (IVH) 3. Periventricular Leukomalacia (PVL) 4. Bronchopulmonary Dysplasia (BPD) 5. Death 6. Operation due to retinopathy (Retinopathy Of Prematurity [ROP]) 7. Patent Ductus Arteriosus (PDA) 8. Necrotising Enterocolitis (NEC) 9. Intestinal perforation 10. Hydrocephalus and ventricular-peritoneal-shunt 11. Number of surfactant doses 12. Total surfactant (mg/kg bodyweight) 13. Days on assisted ventilation 14. Days on supplemental oxygen 15. Duration of hospitalisation 16. Weight gain per day 17. Pneumothorax 18. Other complications of prematurity All outcomes will be measured until discharge. Bronchopulmonary dysplasia will be assessed at 36 weeks + 0 days (+/- 5 days) of corrected gestational age. |
| Overall study start date | 27/09/2007 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 210 |
| Key inclusion criteria | 1. Preterm infants with a gestational age between 26 weeks + 0 days and 28 weeks + 6 days 2. Birth weight below 1500 g 3. Age less than 12 hours |
| Key exclusion criteria | 1. Lethal malformations 2. Prior surfactant treatment without intubation |
| Date of first enrolment | 27/09/2007 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
Universitatsklinikum Schleswig-Holstein
Lubeck
D-23538
Germany
D-23538
Germany
Sponsor information
Schleswig-Holstein University Hospital (Universitatsklinikum Schleswig-Holstein) (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Gopel
Ratzeburger Allee 160
Kinderklinik
Lubeck
D-23538
Germany
| goepel@paedia.ukl.mu-luebeck.de | |
| Website | http://www.uk-sh.de/ |
"ROR" |
https://ror.org/01tvm6f46 |
Funders
Funder type
Industry
Chiesi Farmaceutici S.p.A. (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/11/2011 | Yes | No |
