Avoid Mechanical Ventilation: The AMV-trial

ISRCTN	ISRCTN05025922
DOI	https://doi.org/10.1186/ISRCTN05025922
Clinical Trials Information System (CTIS)	2006-006912-31
Protocol serial number	AMV-12_12_2006 Vers. 2
Sponsor	Schleswig-Holstein University Hospital (Universitatsklinikum Schleswig-Holstein) (Germany)
Funder	Chiesi Farmaceutici S.p.A. (Italy)

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

Universitatsklinikum Schleswig-Holstein
Ratzeburger Allee 160
Kinderklinik
Lubeck
D-23538
Germany

Email	goepel@paedia.ukl.mu-luebeck.de

Study information

Primary study design	Interventional
Study design	Prospective, interventional, randomised controlled multicentre trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Surfactant
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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