Condition category
Neonatal Diseases
Date applied
27/09/2007
Date assigned
15/11/2007
Last edited
20/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wolfgang Gopel

ORCID ID

Contact details

Universitatsklinikum Schleswig-Holstein
Ratzeburger Allee 160
Kinderklinik
Lubeck
D-23538
Germany
goepel@paedia.ukl.mu-luebeck.de

Additional identifiers

EudraCT number

2006-006912-31

ClinicalTrials.gov number

Protocol/serial number

AMV-12_12_2006 Vers. 2

Study information

Scientific title

Acronym

AMV

Study hypothesis

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

Ethics approval received from the local medical ethics committee (Ethikkommission der medizinischen Fakultat der Universitat Lubeck) on the 3rd July 2007 (ref: 07-037).

Study design

Prospective, interventional, randomised controlled multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Surfactant

Primary outcome measures

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 trial start date

27/09/2007

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

210

Participant exclusion criteria

1. Lethal malformations
2. Prior surfactant treatment without intubation

Recruitment start date

27/09/2007

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Universitatsklinikum Schleswig-Holstein
Lubeck
D-23538
Germany

Sponsor information

Organisation

Schleswig-Holstein University Hospital (Universitatsklinikum Schleswig-Holstein) (Germany)

Sponsor details

c/o Dr Gopel
Ratzeburger Allee 160
Kinderklinik
Lubeck
D-23538
Germany
goepel@paedia.ukl.mu-luebeck.de

Sponsor type

Hospital/treatment centre

Website

http://www.uk-sh.de/

Funders

Funder type

Industry

Funder name

Chiesi Farmaceutici S.p.A. (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21963186

Publication citations

  1. Results

    Göpel W, Kribs A, Ziegler A, Laux R, Hoehn T, Wieg C, Siegel J, Avenarius S, von der Wense A, Vochem M, Groneck P, Weller U, Möller J, Härtel C, Haller S, Roth B, Herting E, , Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial., Lancet, 2011, 378, 9803, 1627-1634, doi: 10.1016/S0140-6736(11)60986-0.

Additional files

Editorial Notes